Plasmid Preparation:Article Title: Potential Rapid Diagnostics, Vaccine and Therapeutics for 2019 Novel Coronavirus (2019-nCoV): A Systematic Review
Article Snippet: 4 , GeneOne Life Science and Inovio Pharmaceuticals; GLS-5300 , United States (Maryland) Phase I clinical trial; Open-label, single-arm, dose-escalation study; 3 doses of 0·67 mg, 2 mg, or 6 mg GLS-5300; intramuscular 1 mL injection followed immediately by co-localised intramuscular electroporation with CELLECTRA ® -5P device at week 0, 4 and 12 with follow-up through to 48 weeks after dose 3 , 75 healthy adults between 18 and 50 years old (mean age 32.2 years), with normal screening electrocardiogram, screening laboratory findings within normal limits or be grade 0–1 findings, and have no history of clinically significant immunosuppressive or autoimmune disease, HIV, hepatitis B or C virus infection; 25 subjects were randomised into each dose group and 65 subjects completed the study, and per protocol analysis was used. , No vaccine-associated serious adverse events. 97% participants reported at least one solicited adverse event, but most solicited symptoms were reported as mild and were self-limiting (19 [76%] with 0·67 mg, 20 [80%] with 2 mg, and 17 [68%] with 6 mg); injection site reactions were the most common adverse event [92%]. , Seroconversion measured by S1-ELISA occurred in 86% and 94% participants after 2 and 3 doses, respectively, and was maintained in 79% participants up to study end at week 60. Neutralising antibodies were detected in 50% participants at one or more time points during the study, but only 3% maintained neutralisation activity to end of study. T-cell responses were detected in 71% and 76% participants after 2 and 3 doses, respectively. There were no differences in immune responses between dose groups after 6 weeks and vaccine-induced humoral and cellular responses were respectively detected in 77% and 64% participants at week 60. , [ ] .
Article Title: Development of Middle East Respiratory Syndrome Coronavirus vaccines – advances and challenges
Article Snippet: Vaccine candidates under development are listed in and include: DNA vaccines, protein subunit and peptide vaccines, vector-based vaccines, and live attenuated vaccines. table ft1 table-wrap mode="anchored" t5 Table 1. caption a7 Vaccine platform Vaccine name Viral antigen/Product design Status Animal models Institution Ref. DNA GLS-5300 Full-length S Phase I C57BL/6 mice, camels, rhesus GeneOne Life Science, South Korea 53 Protein subunit S-RBD-Fc S1-RBD fused with human Fc Preclinical BALB/c mice, rabbits, hDPP4-mice New York Blood Center, U.S.A., Fudan University, China 47,69 MERS-CoV rRBD Truncated S1-RBD Preclinical BALB/c mice China CDC 59 rNTD rNTD Preclinical BALB/c mice China CDC 70 MERS-S Nanoparticles Preclinical BALB/c mice Novavax, U.S.A. 74,75 Heterologous prime-boost S-DNA/S1 Protein Full-length S (prime) + S1 subunit (boost) Preclinical BALB/c mice, Rhesus U.S. National Institute of Health 55 Vector ChAdOx1-MERS-S Full-length S Preclinical Mice Jenner Institute, UK 84,99 Ad5-S, Ad41-S Full-length S Preclinical Mice China CDC 79 BNSP333-S1 RABV-S1 Preclinical hDPP4-mice Thomas Jefferson Univ., Univ. of Maryland, NIH, U.S.A. 100 MERS-S/MERS-solS Measles-full-length S/solS Preclinical IFNAR-/-mice Paul Ehrlich Institute 78 GreMERSfi Ad5-full-length S/S1 Preclinical BALB/c Mice Greffex, U.S.A. 101 MVA-MERS-S Full-length S Preclinical hDPP4-mice, planning for phase I German Center for Infection Research (DIFZ) 80 Live attenuated rMERS-CoV-ΔE Recombinant MERS-CoV without E In vitro — Universidad Autonoma de Madrid, Spain 90 Open in a separate window MERS-CoV vaccines under development.
Article Title: Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial
Article Snippet: The Research Monitor will provide an unbiased written report of all unanticipated problems involving risks to participants or others, and related SAEs and deaths, within 10 working days to the WRAIR IRB by email (Usarmy.detrick.medcom-wrair.mbx.hspb@mail.mil), or by mail at the following address: Walter Reed Army Institute of Research, ATTN: Human Subjects Protection Branch, 503 Robert Grant Ave, Silver Spring, MD 20910.
Article Title: Harnessing Recent Advances in Synthetic DNA and Electroporation Technologies for Rapid Vaccine Development Against COVID-19 and Other Emerging Infectious Diseases
Article Snippet: MERS , GLS-5300 , MERS S protein , Phase I , NCT02670187 , IM-EP , GeneOne Life Science; Inovio Pharmaceuticals , Yes , 94 and 50% subjects developed binding and neutralizing antibody responses by the third vaccination , 76% Subjects developed T-cell responses by the third vaccination , ( ) .
Article Title: Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial
Article Snippet: GLS-5300 GeneOne Life Science, Inc. Clinical Protocol Date:13Nov2017 v10.0 -36-
Article Title: Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial
Article Snippet: U.S. BB-IND 16711 Version 10.0 GLS-5300 GeneOne Life Science, Inc. WRAIR 2274, HRPO Log A#19272 Clinical Protocol V10.0 -- Date: 13Nov2017 PHASE I, OPEN-LABEL, DOSE RANGING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF GLS-5300, ADMINISTERED IM FOLLOWED BY ELECTROPORATION IN HEALTHY VOLUNTEERS Drug: GLS-5300 Protocol Number: WRAIR #2274 Sponsor: GeneOne Life Science, Inc. 1040 DeKalb Pike, Suite 200 Blue Bell, PA 19422 Principal Investigator Kayvon Modjarrad, MD, PhD Sponsor Medical Monitor: Joel Maslow, MD PhD MBA FACP Institutional Review Boards WRAIR Institutional Review Board (IRB) Walter Reed Army Institute of Research 503 Robert Grant Avenue Silver Spring, Maryland 20910-7500 Telephone: 301-319-9940 / Fax: 301-319-9961 Email: usarmy.detrick.medcom-wrair.list.humansubjects-protection@mail.mil FWA#: 00000015; IRB#: 00000794 Version and Date: Version 10.0 13Nov2017 CONFIDENTIAL The information in this document is considered privileged and confidential by GeneOne Life Science, Inc. and may not be disclosed to others except to the extent necessary to obtain Institutional Review Board/Ethics committee approval and informed consent, or as required by local regulatory authorities.
Article Title: Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial
Article Snippet: GLS-5300 GeneOne Life Science, Inc. Clinical Protocol Date:13Nov2017 v10.0 -33-
Article Title: Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial
Article Snippet: GLS-5300 GeneOne Life Science, Inc. Clinical Protocol Date:13Nov2017 v10.0 -44-
Mouse Assay:Article Title: Potential Rapid Diagnostics, Vaccine and Therapeutics for 2019 Novel Coronavirus (2019-nCoV): A Systematic Review
Article Snippet: 4 , GeneOne Life Science and Inovio Pharmaceuticals; GLS-5300 , United States (Maryland) Phase I clinical trial; Open-label, single-arm, dose-escalation study; 3 doses of 0·67 mg, 2 mg, or 6 mg GLS-5300; intramuscular 1 mL injection followed immediately by co-localised intramuscular electroporation with CELLECTRA ® -5P device at week 0, 4 and 12 with follow-up through to 48 weeks after dose 3 , 75 healthy adults between 18 and 50 years old (mean age 32.2 years), with normal screening electrocardiogram, screening laboratory findings within normal limits or be grade 0–1 findings, and have no history of clinically significant immunosuppressive or autoimmune disease, HIV, hepatitis B or C virus infection; 25 subjects were randomised into each dose group and 65 subjects completed the study, and per protocol analysis was used. , No vaccine-associated serious adverse events. 97% participants reported at least one solicited adverse event, but most solicited symptoms were reported as mild and were self-limiting (19 [76%] with 0·67 mg, 20 [80%] with 2 mg, and 17 [68%] with 6 mg); injection site reactions were the most common adverse event [92%]. , Seroconversion measured by S1-ELISA occurred in 86% and 94% participants after 2 and 3 doses, respectively, and was maintained in 79% participants up to study end at week 60. Neutralising antibodies were detected in 50% participants at one or more time points during the study, but only 3% maintained neutralisation activity to end of study. T-cell responses were detected in 71% and 76% participants after 2 and 3 doses, respectively. There were no differences in immune responses between dose groups after 6 weeks and vaccine-induced humoral and cellular responses were respectively detected in 77% and 64% participants at week 60. , [ ] .
Article Title: Development of Middle East Respiratory Syndrome Coronavirus vaccines – advances and challenges
Article Snippet: Vaccine candidates under development are listed in and include: DNA vaccines, protein subunit and peptide vaccines, vector-based vaccines, and live attenuated vaccines. table ft1 table-wrap mode="anchored" t5 Table 1. caption a7 Vaccine platform Vaccine name Viral antigen/Product design Status Animal models Institution Ref. DNA GLS-5300 Full-length S Phase I C57BL/6 mice, camels, rhesus GeneOne Life Science, South Korea 53 Protein subunit S-RBD-Fc S1-RBD fused with human Fc Preclinical BALB/c mice, rabbits, hDPP4-mice New York Blood Center, U.S.A., Fudan University, China 47,69 MERS-CoV rRBD Truncated S1-RBD Preclinical BALB/c mice China CDC 59 rNTD rNTD Preclinical BALB/c mice China CDC 70 MERS-S Nanoparticles Preclinical BALB/c mice Novavax, U.S.A. 74,75 Heterologous prime-boost S-DNA/S1 Protein Full-length S (prime) + S1 subunit (boost) Preclinical BALB/c mice, Rhesus U.S. National Institute of Health 55 Vector ChAdOx1-MERS-S Full-length S Preclinical Mice Jenner Institute, UK 84,99 Ad5-S, Ad41-S Full-length S Preclinical Mice China CDC 79 BNSP333-S1 RABV-S1 Preclinical hDPP4-mice Thomas Jefferson Univ., Univ. of Maryland, NIH, U.S.A. 100 MERS-S/MERS-solS Measles-full-length S/solS Preclinical IFNAR-/-mice Paul Ehrlich Institute 78 GreMERSfi Ad5-full-length S/S1 Preclinical BALB/c Mice Greffex, U.S.A. 101 MVA-MERS-S Full-length S Preclinical hDPP4-mice, planning for phase I German Center for Infection Research (DIFZ) 80 Live attenuated rMERS-CoV-ΔE Recombinant MERS-CoV without E In vitro — Universidad Autonoma de Madrid, Spain 90 Open in a separate window MERS-CoV vaccines under development.
Article Title: Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial
Article Snippet: The Research Monitor will provide an unbiased written report of all unanticipated problems involving risks to participants or others, and related SAEs and deaths, within 10 working days to the WRAIR IRB by email (Usarmy.detrick.medcom-wrair.mbx.hspb@mail.mil), or by mail at the following address: Walter Reed Army Institute of Research, ATTN: Human Subjects Protection Branch, 503 Robert Grant Ave, Silver Spring, MD 20910.
Article Title: Harnessing Recent Advances in Synthetic DNA and Electroporation Technologies for Rapid Vaccine Development Against COVID-19 and Other Emerging Infectious Diseases
Article Snippet: MERS , GLS-5300 , MERS S protein , Phase I , NCT02670187 , IM-EP , GeneOne Life Science; Inovio Pharmaceuticals , Yes , 94 and 50% subjects developed binding and neutralizing antibody responses by the third vaccination , 76% Subjects developed T-cell responses by the third vaccination , ( ) .
Article Title: Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial
Article Snippet: GLS-5300 GeneOne Life Science, Inc. Clinical Protocol Date:13Nov2017 v10.0 -36-
Article Title: Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial
Article Snippet: U.S. BB-IND 16711 Version 10.0 GLS-5300 GeneOne Life Science, Inc. WRAIR 2274, HRPO Log A#19272 Clinical Protocol V10.0 -- Date: 13Nov2017 PHASE I, OPEN-LABEL, DOSE RANGING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF GLS-5300, ADMINISTERED IM FOLLOWED BY ELECTROPORATION IN HEALTHY VOLUNTEERS Drug: GLS-5300 Protocol Number: WRAIR #2274 Sponsor: GeneOne Life Science, Inc. 1040 DeKalb Pike, Suite 200 Blue Bell, PA 19422 Principal Investigator Kayvon Modjarrad, MD, PhD Sponsor Medical Monitor: Joel Maslow, MD PhD MBA FACP Institutional Review Boards WRAIR Institutional Review Board (IRB) Walter Reed Army Institute of Research 503 Robert Grant Avenue Silver Spring, Maryland 20910-7500 Telephone: 301-319-9940 / Fax: 301-319-9961 Email: usarmy.detrick.medcom-wrair.list.humansubjects-protection@mail.mil FWA#: 00000015; IRB#: 00000794 Version and Date: Version 10.0 13Nov2017 CONFIDENTIAL The information in this document is considered privileged and confidential by GeneOne Life Science, Inc. and may not be disclosed to others except to the extent necessary to obtain Institutional Review Board/Ethics committee approval and informed consent, or as required by local regulatory authorities.
Article Title: Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial
Article Snippet: GLS-5300 GeneOne Life Science, Inc. Clinical Protocol Date:13Nov2017 v10.0 -33-
Article Title: Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial
Article Snippet: GLS-5300 GeneOne Life Science, Inc. Clinical Protocol Date:13Nov2017 v10.0 -44-
Infection:Article Title: Potential Rapid Diagnostics, Vaccine and Therapeutics for 2019 Novel Coronavirus (2019-nCoV): A Systematic Review
Article Snippet: 4 , GeneOne Life Science and Inovio Pharmaceuticals; GLS-5300 , United States (Maryland) Phase I clinical trial; Open-label, single-arm, dose-escalation study; 3 doses of 0·67 mg, 2 mg, or 6 mg GLS-5300; intramuscular 1 mL injection followed immediately by co-localised intramuscular electroporation with CELLECTRA ® -5P device at week 0, 4 and 12 with follow-up through to 48 weeks after dose 3 , 75 healthy adults between 18 and 50 years old (mean age 32.2 years), with normal screening electrocardiogram, screening laboratory findings within normal limits or be grade 0–1 findings, and have no history of clinically significant immunosuppressive or autoimmune disease, HIV, hepatitis B or C virus infection; 25 subjects were randomised into each dose group and 65 subjects completed the study, and per protocol analysis was used. , No vaccine-associated serious adverse events. 97% participants reported at least one solicited adverse event, but most solicited symptoms were reported as mild and were self-limiting (19 [76%] with 0·67 mg, 20 [80%] with 2 mg, and 17 [68%] with 6 mg); injection site reactions were the most common adverse event [92%]. , Seroconversion measured by S1-ELISA occurred in 86% and 94% participants after 2 and 3 doses, respectively, and was maintained in 79% participants up to study end at week 60. Neutralising antibodies were detected in 50% participants at one or more time points during the study, but only 3% maintained neutralisation activity to end of study. T-cell responses were detected in 71% and 76% participants after 2 and 3 doses, respectively. There were no differences in immune responses between dose groups after 6 weeks and vaccine-induced humoral and cellular responses were respectively detected in 77% and 64% participants at week 60. , [ ] .
Article Title: Development of Middle East Respiratory Syndrome Coronavirus vaccines – advances and challenges
Article Snippet: Vaccine candidates under development are listed in and include: DNA vaccines, protein subunit and peptide vaccines, vector-based vaccines, and live attenuated vaccines. table ft1 table-wrap mode="anchored" t5 Table 1. caption a7 Vaccine platform Vaccine name Viral antigen/Product design Status Animal models Institution Ref. DNA GLS-5300 Full-length S Phase I C57BL/6 mice, camels, rhesus GeneOne Life Science, South Korea 53 Protein subunit S-RBD-Fc S1-RBD fused with human Fc Preclinical BALB/c mice, rabbits, hDPP4-mice New York Blood Center, U.S.A., Fudan University, China 47,69 MERS-CoV rRBD Truncated S1-RBD Preclinical BALB/c mice China CDC 59 rNTD rNTD Preclinical BALB/c mice China CDC 70 MERS-S Nanoparticles Preclinical BALB/c mice Novavax, U.S.A. 74,75 Heterologous prime-boost S-DNA/S1 Protein Full-length S (prime) + S1 subunit (boost) Preclinical BALB/c mice, Rhesus U.S. National Institute of Health 55 Vector ChAdOx1-MERS-S Full-length S Preclinical Mice Jenner Institute, UK 84,99 Ad5-S, Ad41-S Full-length S Preclinical Mice China CDC 79 BNSP333-S1 RABV-S1 Preclinical hDPP4-mice Thomas Jefferson Univ., Univ. of Maryland, NIH, U.S.A. 100 MERS-S/MERS-solS Measles-full-length S/solS Preclinical IFNAR-/-mice Paul Ehrlich Institute 78 GreMERSfi Ad5-full-length S/S1 Preclinical BALB/c Mice Greffex, U.S.A. 101 MVA-MERS-S Full-length S Preclinical hDPP4-mice, planning for phase I German Center for Infection Research (DIFZ) 80 Live attenuated rMERS-CoV-ΔE Recombinant MERS-CoV without E In vitro — Universidad Autonoma de Madrid, Spain 90 Open in a separate window MERS-CoV vaccines under development.
Article Title: Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial
Article Snippet: The Research Monitor will provide an unbiased written report of all unanticipated problems involving risks to participants or others, and related SAEs and deaths, within 10 working days to the WRAIR IRB by email (Usarmy.detrick.medcom-wrair.mbx.hspb@mail.mil), or by mail at the following address: Walter Reed Army Institute of Research, ATTN: Human Subjects Protection Branch, 503 Robert Grant Ave, Silver Spring, MD 20910.
Article Title: Harnessing Recent Advances in Synthetic DNA and Electroporation Technologies for Rapid Vaccine Development Against COVID-19 and Other Emerging Infectious Diseases
Article Snippet: MERS , GLS-5300 , MERS S protein , Phase I , NCT02670187 , IM-EP , GeneOne Life Science; Inovio Pharmaceuticals , Yes , 94 and 50% subjects developed binding and neutralizing antibody responses by the third vaccination , 76% Subjects developed T-cell responses by the third vaccination , ( ) .
Article Title: Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial
Article Snippet: GLS-5300 GeneOne Life Science, Inc. Clinical Protocol Date:13Nov2017 v10.0 -36-
Article Title: Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial
Article Snippet: U.S. BB-IND 16711 Version 10.0 GLS-5300 GeneOne Life Science, Inc. WRAIR 2274, HRPO Log A#19272 Clinical Protocol V10.0 -- Date: 13Nov2017 PHASE I, OPEN-LABEL, DOSE RANGING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF GLS-5300, ADMINISTERED IM FOLLOWED BY ELECTROPORATION IN HEALTHY VOLUNTEERS Drug: GLS-5300 Protocol Number: WRAIR #2274 Sponsor: GeneOne Life Science, Inc. 1040 DeKalb Pike, Suite 200 Blue Bell, PA 19422 Principal Investigator Kayvon Modjarrad, MD, PhD Sponsor Medical Monitor: Joel Maslow, MD PhD MBA FACP Institutional Review Boards WRAIR Institutional Review Board (IRB) Walter Reed Army Institute of Research 503 Robert Grant Avenue Silver Spring, Maryland 20910-7500 Telephone: 301-319-9940 / Fax: 301-319-9961 Email: usarmy.detrick.medcom-wrair.list.humansubjects-protection@mail.mil FWA#: 00000015; IRB#: 00000794 Version and Date: Version 10.0 13Nov2017 CONFIDENTIAL The information in this document is considered privileged and confidential by GeneOne Life Science, Inc. and may not be disclosed to others except to the extent necessary to obtain Institutional Review Board/Ethics committee approval and informed consent, or as required by local regulatory authorities.
Article Title: Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial
Article Snippet: GLS-5300 GeneOne Life Science, Inc. Clinical Protocol Date:13Nov2017 v10.0 -33-
Article Title: Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial
Article Snippet: GLS-5300 GeneOne Life Science, Inc. Clinical Protocol Date:13Nov2017 v10.0 -44-
Recombinant:Article Title: Potential Rapid Diagnostics, Vaccine and Therapeutics for 2019 Novel Coronavirus (2019-nCoV): A Systematic Review
Article Snippet: 4 , GeneOne Life Science and Inovio Pharmaceuticals; GLS-5300 , United States (Maryland) Phase I clinical trial; Open-label, single-arm, dose-escalation study; 3 doses of 0·67 mg, 2 mg, or 6 mg GLS-5300; intramuscular 1 mL injection followed immediately by co-localised intramuscular electroporation with CELLECTRA ® -5P device at week 0, 4 and 12 with follow-up through to 48 weeks after dose 3 , 75 healthy adults between 18 and 50 years old (mean age 32.2 years), with normal screening electrocardiogram, screening laboratory findings within normal limits or be grade 0–1 findings, and have no history of clinically significant immunosuppressive or autoimmune disease, HIV, hepatitis B or C virus infection; 25 subjects were randomised into each dose group and 65 subjects completed the study, and per protocol analysis was used. , No vaccine-associated serious adverse events. 97% participants reported at least one solicited adverse event, but most solicited symptoms were reported as mild and were self-limiting (19 [76%] with 0·67 mg, 20 [80%] with 2 mg, and 17 [68%] with 6 mg); injection site reactions were the most common adverse event [92%]. , Seroconversion measured by S1-ELISA occurred in 86% and 94% participants after 2 and 3 doses, respectively, and was maintained in 79% participants up to study end at week 60. Neutralising antibodies were detected in 50% participants at one or more time points during the study, but only 3% maintained neutralisation activity to end of study. T-cell responses were detected in 71% and 76% participants after 2 and 3 doses, respectively. There were no differences in immune responses between dose groups after 6 weeks and vaccine-induced humoral and cellular responses were respectively detected in 77% and 64% participants at week 60. , [ ] .
Article Title: Development of Middle East Respiratory Syndrome Coronavirus vaccines – advances and challenges
Article Snippet: Vaccine candidates under development are listed in and include: DNA vaccines, protein subunit and peptide vaccines, vector-based vaccines, and live attenuated vaccines. table ft1 table-wrap mode="anchored" t5 Table 1. caption a7 Vaccine platform Vaccine name Viral antigen/Product design Status Animal models Institution Ref. DNA GLS-5300 Full-length S Phase I C57BL/6 mice, camels, rhesus GeneOne Life Science, South Korea 53 Protein subunit S-RBD-Fc S1-RBD fused with human Fc Preclinical BALB/c mice, rabbits, hDPP4-mice New York Blood Center, U.S.A., Fudan University, China 47,69 MERS-CoV rRBD Truncated S1-RBD Preclinical BALB/c mice China CDC 59 rNTD rNTD Preclinical BALB/c mice China CDC 70 MERS-S Nanoparticles Preclinical BALB/c mice Novavax, U.S.A. 74,75 Heterologous prime-boost S-DNA/S1 Protein Full-length S (prime) + S1 subunit (boost) Preclinical BALB/c mice, Rhesus U.S. National Institute of Health 55 Vector ChAdOx1-MERS-S Full-length S Preclinical Mice Jenner Institute, UK 84,99 Ad5-S, Ad41-S Full-length S Preclinical Mice China CDC 79 BNSP333-S1 RABV-S1 Preclinical hDPP4-mice Thomas Jefferson Univ., Univ. of Maryland, NIH, U.S.A. 100 MERS-S/MERS-solS Measles-full-length S/solS Preclinical IFNAR-/-mice Paul Ehrlich Institute 78 GreMERSfi Ad5-full-length S/S1 Preclinical BALB/c Mice Greffex, U.S.A. 101 MVA-MERS-S Full-length S Preclinical hDPP4-mice, planning for phase I German Center for Infection Research (DIFZ) 80 Live attenuated rMERS-CoV-ΔE Recombinant MERS-CoV without E In vitro — Universidad Autonoma de Madrid, Spain 90 Open in a separate window MERS-CoV vaccines under development.
Article Title: Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial
Article Snippet: The Research Monitor will provide an unbiased written report of all unanticipated problems involving risks to participants or others, and related SAEs and deaths, within 10 working days to the WRAIR IRB by email (Usarmy.detrick.medcom-wrair.mbx.hspb@mail.mil), or by mail at the following address: Walter Reed Army Institute of Research, ATTN: Human Subjects Protection Branch, 503 Robert Grant Ave, Silver Spring, MD 20910.
Article Title: Harnessing Recent Advances in Synthetic DNA and Electroporation Technologies for Rapid Vaccine Development Against COVID-19 and Other Emerging Infectious Diseases
Article Snippet: MERS , GLS-5300 , MERS S protein , Phase I , NCT02670187 , IM-EP , GeneOne Life Science; Inovio Pharmaceuticals , Yes , 94 and 50% subjects developed binding and neutralizing antibody responses by the third vaccination , 76% Subjects developed T-cell responses by the third vaccination , ( ) .
Article Title: Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial
Article Snippet: GLS-5300 GeneOne Life Science, Inc. Clinical Protocol Date:13Nov2017 v10.0 -36-
Article Title: Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial
Article Snippet: U.S. BB-IND 16711 Version 10.0 GLS-5300 GeneOne Life Science, Inc. WRAIR 2274, HRPO Log A#19272 Clinical Protocol V10.0 -- Date: 13Nov2017 PHASE I, OPEN-LABEL, DOSE RANGING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF GLS-5300, ADMINISTERED IM FOLLOWED BY ELECTROPORATION IN HEALTHY VOLUNTEERS Drug: GLS-5300 Protocol Number: WRAIR #2274 Sponsor: GeneOne Life Science, Inc. 1040 DeKalb Pike, Suite 200 Blue Bell, PA 19422 Principal Investigator Kayvon Modjarrad, MD, PhD Sponsor Medical Monitor: Joel Maslow, MD PhD MBA FACP Institutional Review Boards WRAIR Institutional Review Board (IRB) Walter Reed Army Institute of Research 503 Robert Grant Avenue Silver Spring, Maryland 20910-7500 Telephone: 301-319-9940 / Fax: 301-319-9961 Email: usarmy.detrick.medcom-wrair.list.humansubjects-protection@mail.mil FWA#: 00000015; IRB#: 00000794 Version and Date: Version 10.0 13Nov2017 CONFIDENTIAL The information in this document is considered privileged and confidential by GeneOne Life Science, Inc. and may not be disclosed to others except to the extent necessary to obtain Institutional Review Board/Ethics committee approval and informed consent, or as required by local regulatory authorities.
Article Title: Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial
Article Snippet: GLS-5300 GeneOne Life Science, Inc. Clinical Protocol Date:13Nov2017 v10.0 -33-
Article Title: Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial
Article Snippet: GLS-5300 GeneOne Life Science, Inc. Clinical Protocol Date:13Nov2017 v10.0 -44-
In Vitro:Article Title: Potential Rapid Diagnostics, Vaccine and Therapeutics for 2019 Novel Coronavirus (2019-nCoV): A Systematic Review
Article Snippet: 4 , GeneOne Life Science and Inovio Pharmaceuticals; GLS-5300 , United States (Maryland) Phase I clinical trial; Open-label, single-arm, dose-escalation study; 3 doses of 0·67 mg, 2 mg, or 6 mg GLS-5300; intramuscular 1 mL injection followed immediately by co-localised intramuscular electroporation with CELLECTRA ® -5P device at week 0, 4 and 12 with follow-up through to 48 weeks after dose 3 , 75 healthy adults between 18 and 50 years old (mean age 32.2 years), with normal screening electrocardiogram, screening laboratory findings within normal limits or be grade 0–1 findings, and have no history of clinically significant immunosuppressive or autoimmune disease, HIV, hepatitis B or C virus infection; 25 subjects were randomised into each dose group and 65 subjects completed the study, and per protocol analysis was used. , No vaccine-associated serious adverse events. 97% participants reported at least one solicited adverse event, but most solicited symptoms were reported as mild and were self-limiting (19 [76%] with 0·67 mg, 20 [80%] with 2 mg, and 17 [68%] with 6 mg); injection site reactions were the most common adverse event [92%]. , Seroconversion measured by S1-ELISA occurred in 86% and 94% participants after 2 and 3 doses, respectively, and was maintained in 79% participants up to study end at week 60. Neutralising antibodies were detected in 50% participants at one or more time points during the study, but only 3% maintained neutralisation activity to end of study. T-cell responses were detected in 71% and 76% participants after 2 and 3 doses, respectively. There were no differences in immune responses between dose groups after 6 weeks and vaccine-induced humoral and cellular responses were respectively detected in 77% and 64% participants at week 60. , [ ] .
Article Title: Development of Middle East Respiratory Syndrome Coronavirus vaccines – advances and challenges
Article Snippet: Vaccine candidates under development are listed in and include: DNA vaccines, protein subunit and peptide vaccines, vector-based vaccines, and live attenuated vaccines. table ft1 table-wrap mode="anchored" t5 Table 1. caption a7 Vaccine platform Vaccine name Viral antigen/Product design Status Animal models Institution Ref. DNA GLS-5300 Full-length S Phase I C57BL/6 mice, camels, rhesus GeneOne Life Science, South Korea 53 Protein subunit S-RBD-Fc S1-RBD fused with human Fc Preclinical BALB/c mice, rabbits, hDPP4-mice New York Blood Center, U.S.A., Fudan University, China 47,69 MERS-CoV rRBD Truncated S1-RBD Preclinical BALB/c mice China CDC 59 rNTD rNTD Preclinical BALB/c mice China CDC 70 MERS-S Nanoparticles Preclinical BALB/c mice Novavax, U.S.A. 74,75 Heterologous prime-boost S-DNA/S1 Protein Full-length S (prime) + S1 subunit (boost) Preclinical BALB/c mice, Rhesus U.S. National Institute of Health 55 Vector ChAdOx1-MERS-S Full-length S Preclinical Mice Jenner Institute, UK 84,99 Ad5-S, Ad41-S Full-length S Preclinical Mice China CDC 79 BNSP333-S1 RABV-S1 Preclinical hDPP4-mice Thomas Jefferson Univ., Univ. of Maryland, NIH, U.S.A. 100 MERS-S/MERS-solS Measles-full-length S/solS Preclinical IFNAR-/-mice Paul Ehrlich Institute 78 GreMERSfi Ad5-full-length S/S1 Preclinical BALB/c Mice Greffex, U.S.A. 101 MVA-MERS-S Full-length S Preclinical hDPP4-mice, planning for phase I German Center for Infection Research (DIFZ) 80 Live attenuated rMERS-CoV-ΔE Recombinant MERS-CoV without E In vitro — Universidad Autonoma de Madrid, Spain 90 Open in a separate window MERS-CoV vaccines under development.
Article Title: Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial
Article Snippet: The Research Monitor will provide an unbiased written report of all unanticipated problems involving risks to participants or others, and related SAEs and deaths, within 10 working days to the WRAIR IRB by email (Usarmy.detrick.medcom-wrair.mbx.hspb@mail.mil), or by mail at the following address: Walter Reed Army Institute of Research, ATTN: Human Subjects Protection Branch, 503 Robert Grant Ave, Silver Spring, MD 20910.
Article Title: Harnessing Recent Advances in Synthetic DNA and Electroporation Technologies for Rapid Vaccine Development Against COVID-19 and Other Emerging Infectious Diseases
Article Snippet: MERS , GLS-5300 , MERS S protein , Phase I , NCT02670187 , IM-EP , GeneOne Life Science; Inovio Pharmaceuticals , Yes , 94 and 50% subjects developed binding and neutralizing antibody responses by the third vaccination , 76% Subjects developed T-cell responses by the third vaccination , ( ) .
Article Title: Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial
Article Snippet: GLS-5300 GeneOne Life Science, Inc. Clinical Protocol Date:13Nov2017 v10.0 -36-
Article Title: Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial
Article Snippet: U.S. BB-IND 16711 Version 10.0 GLS-5300 GeneOne Life Science, Inc. WRAIR 2274, HRPO Log A#19272 Clinical Protocol V10.0 -- Date: 13Nov2017 PHASE I, OPEN-LABEL, DOSE RANGING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF GLS-5300, ADMINISTERED IM FOLLOWED BY ELECTROPORATION IN HEALTHY VOLUNTEERS Drug: GLS-5300 Protocol Number: WRAIR #2274 Sponsor: GeneOne Life Science, Inc. 1040 DeKalb Pike, Suite 200 Blue Bell, PA 19422 Principal Investigator Kayvon Modjarrad, MD, PhD Sponsor Medical Monitor: Joel Maslow, MD PhD MBA FACP Institutional Review Boards WRAIR Institutional Review Board (IRB) Walter Reed Army Institute of Research 503 Robert Grant Avenue Silver Spring, Maryland 20910-7500 Telephone: 301-319-9940 / Fax: 301-319-9961 Email: usarmy.detrick.medcom-wrair.list.humansubjects-protection@mail.mil FWA#: 00000015; IRB#: 00000794 Version and Date: Version 10.0 13Nov2017 CONFIDENTIAL The information in this document is considered privileged and confidential by GeneOne Life Science, Inc. and may not be disclosed to others except to the extent necessary to obtain Institutional Review Board/Ethics committee approval and informed consent, or as required by local regulatory authorities.
Article Title: Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial
Article Snippet: GLS-5300 GeneOne Life Science, Inc. Clinical Protocol Date:13Nov2017 v10.0 -33-
Article Title: Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial
Article Snippet: GLS-5300 GeneOne Life Science, Inc. Clinical Protocol Date:13Nov2017 v10.0 -44-
Injection:Article Title: Potential Rapid Diagnostics, Vaccine and Therapeutics for 2019 Novel Coronavirus (2019-nCoV): A Systematic Review
Article Snippet: 4 , GeneOne Life Science and Inovio Pharmaceuticals; GLS-5300 , United States (Maryland) Phase I clinical trial; Open-label, single-arm, dose-escalation study; 3 doses of 0·67 mg, 2 mg, or 6 mg GLS-5300; intramuscular 1 mL injection followed immediately by co-localised intramuscular electroporation with CELLECTRA ® -5P device at week 0, 4 and 12 with follow-up through to 48 weeks after dose 3 , 75 healthy adults between 18 and 50 years old (mean age 32.2 years), with normal screening electrocardiogram, screening laboratory findings within normal limits or be grade 0–1 findings, and have no history of clinically significant immunosuppressive or autoimmune disease, HIV, hepatitis B or C virus infection; 25 subjects were randomised into each dose group and 65 subjects completed the study, and per protocol analysis was used. , No vaccine-associated serious adverse events. 97% participants reported at least one solicited adverse event, but most solicited symptoms were reported as mild and were self-limiting (19 [76%] with 0·67 mg, 20 [80%] with 2 mg, and 17 [68%] with 6 mg); injection site reactions were the most common adverse event [92%]. , Seroconversion measured by S1-ELISA occurred in 86% and 94% participants after 2 and 3 doses, respectively, and was maintained in 79% participants up to study end at week 60. Neutralising antibodies were detected in 50% participants at one or more time points during the study, but only 3% maintained neutralisation activity to end of study. T-cell responses were detected in 71% and 76% participants after 2 and 3 doses, respectively. There were no differences in immune responses between dose groups after 6 weeks and vaccine-induced humoral and cellular responses were respectively detected in 77% and 64% participants at week 60. , [ ] .
Article Title: Development of Middle East Respiratory Syndrome Coronavirus vaccines – advances and challenges
Article Snippet: Vaccine candidates under development are listed in and include: DNA vaccines, protein subunit and peptide vaccines, vector-based vaccines, and live attenuated vaccines. table ft1 table-wrap mode="anchored" t5 Table 1. caption a7 Vaccine platform Vaccine name Viral antigen/Product design Status Animal models Institution Ref. DNA GLS-5300 Full-length S Phase I C57BL/6 mice, camels, rhesus GeneOne Life Science, South Korea 53 Protein subunit S-RBD-Fc S1-RBD fused with human Fc Preclinical BALB/c mice, rabbits, hDPP4-mice New York Blood Center, U.S.A., Fudan University, China 47,69 MERS-CoV rRBD Truncated S1-RBD Preclinical BALB/c mice China CDC 59 rNTD rNTD Preclinical BALB/c mice China CDC 70 MERS-S Nanoparticles Preclinical BALB/c mice Novavax, U.S.A. 74,75 Heterologous prime-boost S-DNA/S1 Protein Full-length S (prime) + S1 subunit (boost) Preclinical BALB/c mice, Rhesus U.S. National Institute of Health 55 Vector ChAdOx1-MERS-S Full-length S Preclinical Mice Jenner Institute, UK 84,99 Ad5-S, Ad41-S Full-length S Preclinical Mice China CDC 79 BNSP333-S1 RABV-S1 Preclinical hDPP4-mice Thomas Jefferson Univ., Univ. of Maryland, NIH, U.S.A. 100 MERS-S/MERS-solS Measles-full-length S/solS Preclinical IFNAR-/-mice Paul Ehrlich Institute 78 GreMERSfi Ad5-full-length S/S1 Preclinical BALB/c Mice Greffex, U.S.A. 101 MVA-MERS-S Full-length S Preclinical hDPP4-mice, planning for phase I German Center for Infection Research (DIFZ) 80 Live attenuated rMERS-CoV-ΔE Recombinant MERS-CoV without E In vitro — Universidad Autonoma de Madrid, Spain 90 Open in a separate window MERS-CoV vaccines under development.
Article Title: Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial
Article Snippet: The Research Monitor will provide an unbiased written report of all unanticipated problems involving risks to participants or others, and related SAEs and deaths, within 10 working days to the WRAIR IRB by email (Usarmy.detrick.medcom-wrair.mbx.hspb@mail.mil), or by mail at the following address: Walter Reed Army Institute of Research, ATTN: Human Subjects Protection Branch, 503 Robert Grant Ave, Silver Spring, MD 20910.
Article Title: Harnessing Recent Advances in Synthetic DNA and Electroporation Technologies for Rapid Vaccine Development Against COVID-19 and Other Emerging Infectious Diseases
Article Snippet: MERS , GLS-5300 , MERS S protein , Phase I , NCT02670187 , IM-EP , GeneOne Life Science; Inovio Pharmaceuticals , Yes , 94 and 50% subjects developed binding and neutralizing antibody responses by the third vaccination , 76% Subjects developed T-cell responses by the third vaccination , ( ) .
Article Title: Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial
Article Snippet: GLS-5300 GeneOne Life Science, Inc. Clinical Protocol Date:13Nov2017 v10.0 -36-
Article Title: Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial
Article Snippet: U.S. BB-IND 16711 Version 10.0 GLS-5300 GeneOne Life Science, Inc. WRAIR 2274, HRPO Log A#19272 Clinical Protocol V10.0 -- Date: 13Nov2017 PHASE I, OPEN-LABEL, DOSE RANGING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF GLS-5300, ADMINISTERED IM FOLLOWED BY ELECTROPORATION IN HEALTHY VOLUNTEERS Drug: GLS-5300 Protocol Number: WRAIR #2274 Sponsor: GeneOne Life Science, Inc. 1040 DeKalb Pike, Suite 200 Blue Bell, PA 19422 Principal Investigator Kayvon Modjarrad, MD, PhD Sponsor Medical Monitor: Joel Maslow, MD PhD MBA FACP Institutional Review Boards WRAIR Institutional Review Board (IRB) Walter Reed Army Institute of Research 503 Robert Grant Avenue Silver Spring, Maryland 20910-7500 Telephone: 301-319-9940 / Fax: 301-319-9961 Email: usarmy.detrick.medcom-wrair.list.humansubjects-protection@mail.mil FWA#: 00000015; IRB#: 00000794 Version and Date: Version 10.0 13Nov2017 CONFIDENTIAL The information in this document is considered privileged and confidential by GeneOne Life Science, Inc. and may not be disclosed to others except to the extent necessary to obtain Institutional Review Board/Ethics committee approval and informed consent, or as required by local regulatory authorities.
Article Title: Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial
Article Snippet: GLS-5300 GeneOne Life Science, Inc. Clinical Protocol Date:13Nov2017 v10.0 -33-
Article Title: Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial
Article Snippet: GLS-5300 GeneOne Life Science, Inc. Clinical Protocol Date:13Nov2017 v10.0 -44-
Electroporation:Article Title: Potential Rapid Diagnostics, Vaccine and Therapeutics for 2019 Novel Coronavirus (2019-nCoV): A Systematic Review
Article Snippet: 4 , GeneOne Life Science and Inovio Pharmaceuticals; GLS-5300 , United States (Maryland) Phase I clinical trial; Open-label, single-arm, dose-escalation study; 3 doses of 0·67 mg, 2 mg, or 6 mg GLS-5300; intramuscular 1 mL injection followed immediately by co-localised intramuscular electroporation with CELLECTRA ® -5P device at week 0, 4 and 12 with follow-up through to 48 weeks after dose 3 , 75 healthy adults between 18 and 50 years old (mean age 32.2 years), with normal screening electrocardiogram, screening laboratory findings within normal limits or be grade 0–1 findings, and have no history of clinically significant immunosuppressive or autoimmune disease, HIV, hepatitis B or C virus infection; 25 subjects were randomised into each dose group and 65 subjects completed the study, and per protocol analysis was used. , No vaccine-associated serious adverse events. 97% participants reported at least one solicited adverse event, but most solicited symptoms were reported as mild and were self-limiting (19 [76%] with 0·67 mg, 20 [80%] with 2 mg, and 17 [68%] with 6 mg); injection site reactions were the most common adverse event [92%]. , Seroconversion measured by S1-ELISA occurred in 86% and 94% participants after 2 and 3 doses, respectively, and was maintained in 79% participants up to study end at week 60. Neutralising antibodies were detected in 50% participants at one or more time points during the study, but only 3% maintained neutralisation activity to end of study. T-cell responses were detected in 71% and 76% participants after 2 and 3 doses, respectively. There were no differences in immune responses between dose groups after 6 weeks and vaccine-induced humoral and cellular responses were respectively detected in 77% and 64% participants at week 60. , [ ] .
Article Title: Development of Middle East Respiratory Syndrome Coronavirus vaccines – advances and challenges
Article Snippet: Vaccine candidates under development are listed in and include: DNA vaccines, protein subunit and peptide vaccines, vector-based vaccines, and live attenuated vaccines. table ft1 table-wrap mode="anchored" t5 Table 1. caption a7 Vaccine platform Vaccine name Viral antigen/Product design Status Animal models Institution Ref. DNA GLS-5300 Full-length S Phase I C57BL/6 mice, camels, rhesus GeneOne Life Science, South Korea 53 Protein subunit S-RBD-Fc S1-RBD fused with human Fc Preclinical BALB/c mice, rabbits, hDPP4-mice New York Blood Center, U.S.A., Fudan University, China 47,69 MERS-CoV rRBD Truncated S1-RBD Preclinical BALB/c mice China CDC 59 rNTD rNTD Preclinical BALB/c mice China CDC 70 MERS-S Nanoparticles Preclinical BALB/c mice Novavax, U.S.A. 74,75 Heterologous prime-boost S-DNA/S1 Protein Full-length S (prime) + S1 subunit (boost) Preclinical BALB/c mice, Rhesus U.S. National Institute of Health 55 Vector ChAdOx1-MERS-S Full-length S Preclinical Mice Jenner Institute, UK 84,99 Ad5-S, Ad41-S Full-length S Preclinical Mice China CDC 79 BNSP333-S1 RABV-S1 Preclinical hDPP4-mice Thomas Jefferson Univ., Univ. of Maryland, NIH, U.S.A. 100 MERS-S/MERS-solS Measles-full-length S/solS Preclinical IFNAR-/-mice Paul Ehrlich Institute 78 GreMERSfi Ad5-full-length S/S1 Preclinical BALB/c Mice Greffex, U.S.A. 101 MVA-MERS-S Full-length S Preclinical hDPP4-mice, planning for phase I German Center for Infection Research (DIFZ) 80 Live attenuated rMERS-CoV-ΔE Recombinant MERS-CoV without E In vitro — Universidad Autonoma de Madrid, Spain 90 Open in a separate window MERS-CoV vaccines under development.
Article Title: Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial
Article Snippet: The Research Monitor will provide an unbiased written report of all unanticipated problems involving risks to participants or others, and related SAEs and deaths, within 10 working days to the WRAIR IRB by email (Usarmy.detrick.medcom-wrair.mbx.hspb@mail.mil), or by mail at the following address: Walter Reed Army Institute of Research, ATTN: Human Subjects Protection Branch, 503 Robert Grant Ave, Silver Spring, MD 20910.
Article Title: Harnessing Recent Advances in Synthetic DNA and Electroporation Technologies for Rapid Vaccine Development Against COVID-19 and Other Emerging Infectious Diseases
Article Snippet: MERS , GLS-5300 , MERS S protein , Phase I , NCT02670187 , IM-EP , GeneOne Life Science; Inovio Pharmaceuticals , Yes , 94 and 50% subjects developed binding and neutralizing antibody responses by the third vaccination , 76% Subjects developed T-cell responses by the third vaccination , ( ) .
Article Title: Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial
Article Snippet: GLS-5300 GeneOne Life Science, Inc. Clinical Protocol Date:13Nov2017 v10.0 -36-
Article Title: Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial
Article Snippet: U.S. BB-IND 16711 Version 10.0 GLS-5300 GeneOne Life Science, Inc. WRAIR 2274, HRPO Log A#19272 Clinical Protocol V10.0 -- Date: 13Nov2017 PHASE I, OPEN-LABEL, DOSE RANGING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF GLS-5300, ADMINISTERED IM FOLLOWED BY ELECTROPORATION IN HEALTHY VOLUNTEERS Drug: GLS-5300 Protocol Number: WRAIR #2274 Sponsor: GeneOne Life Science, Inc. 1040 DeKalb Pike, Suite 200 Blue Bell, PA 19422 Principal Investigator Kayvon Modjarrad, MD, PhD Sponsor Medical Monitor: Joel Maslow, MD PhD MBA FACP Institutional Review Boards WRAIR Institutional Review Board (IRB) Walter Reed Army Institute of Research 503 Robert Grant Avenue Silver Spring, Maryland 20910-7500 Telephone: 301-319-9940 / Fax: 301-319-9961 Email: usarmy.detrick.medcom-wrair.list.humansubjects-protection@mail.mil FWA#: 00000015; IRB#: 00000794 Version and Date: Version 10.0 13Nov2017 CONFIDENTIAL The information in this document is considered privileged and confidential by GeneOne Life Science, Inc. and may not be disclosed to others except to the extent necessary to obtain Institutional Review Board/Ethics committee approval and informed consent, or as required by local regulatory authorities.
Article Title: Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial
Article Snippet: GLS-5300 GeneOne Life Science, Inc. Clinical Protocol Date:13Nov2017 v10.0 -33-
Article Title: Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial
Article Snippet: GLS-5300 GeneOne Life Science, Inc. Clinical Protocol Date:13Nov2017 v10.0 -44-
Virus:Article Title: Potential Rapid Diagnostics, Vaccine and Therapeutics for 2019 Novel Coronavirus (2019-nCoV): A Systematic Review
Article Snippet: 4 , GeneOne Life Science and Inovio Pharmaceuticals; GLS-5300 , United States (Maryland) Phase I clinical trial; Open-label, single-arm, dose-escalation study; 3 doses of 0·67 mg, 2 mg, or 6 mg GLS-5300; intramuscular 1 mL injection followed immediately by co-localised intramuscular electroporation with CELLECTRA ® -5P device at week 0, 4 and 12 with follow-up through to 48 weeks after dose 3 , 75 healthy adults between 18 and 50 years old (mean age 32.2 years), with normal screening electrocardiogram, screening laboratory findings within normal limits or be grade 0–1 findings, and have no history of clinically significant immunosuppressive or autoimmune disease, HIV, hepatitis B or C virus infection; 25 subjects were randomised into each dose group and 65 subjects completed the study, and per protocol analysis was used. , No vaccine-associated serious adverse events. 97% participants reported at least one solicited adverse event, but most solicited symptoms were reported as mild and were self-limiting (19 [76%] with 0·67 mg, 20 [80%] with 2 mg, and 17 [68%] with 6 mg); injection site reactions were the most common adverse event [92%]. , Seroconversion measured by S1-ELISA occurred in 86% and 94% participants after 2 and 3 doses, respectively, and was maintained in 79% participants up to study end at week 60. Neutralising antibodies were detected in 50% participants at one or more time points during the study, but only 3% maintained neutralisation activity to end of study. T-cell responses were detected in 71% and 76% participants after 2 and 3 doses, respectively. There were no differences in immune responses between dose groups after 6 weeks and vaccine-induced humoral and cellular responses were respectively detected in 77% and 64% participants at week 60. , [ ] .
Article Title: Development of Middle East Respiratory Syndrome Coronavirus vaccines – advances and challenges
Article Snippet: Vaccine candidates under development are listed in and include: DNA vaccines, protein subunit and peptide vaccines, vector-based vaccines, and live attenuated vaccines. table ft1 table-wrap mode="anchored" t5 Table 1. caption a7 Vaccine platform Vaccine name Viral antigen/Product design Status Animal models Institution Ref. DNA GLS-5300 Full-length S Phase I C57BL/6 mice, camels, rhesus GeneOne Life Science, South Korea 53 Protein subunit S-RBD-Fc S1-RBD fused with human Fc Preclinical BALB/c mice, rabbits, hDPP4-mice New York Blood Center, U.S.A., Fudan University, China 47,69 MERS-CoV rRBD Truncated S1-RBD Preclinical BALB/c mice China CDC 59 rNTD rNTD Preclinical BALB/c mice China CDC 70 MERS-S Nanoparticles Preclinical BALB/c mice Novavax, U.S.A. 74,75 Heterologous prime-boost S-DNA/S1 Protein Full-length S (prime) + S1 subunit (boost) Preclinical BALB/c mice, Rhesus U.S. National Institute of Health 55 Vector ChAdOx1-MERS-S Full-length S Preclinical Mice Jenner Institute, UK 84,99 Ad5-S, Ad41-S Full-length S Preclinical Mice China CDC 79 BNSP333-S1 RABV-S1 Preclinical hDPP4-mice Thomas Jefferson Univ., Univ. of Maryland, NIH, U.S.A. 100 MERS-S/MERS-solS Measles-full-length S/solS Preclinical IFNAR-/-mice Paul Ehrlich Institute 78 GreMERSfi Ad5-full-length S/S1 Preclinical BALB/c Mice Greffex, U.S.A. 101 MVA-MERS-S Full-length S Preclinical hDPP4-mice, planning for phase I German Center for Infection Research (DIFZ) 80 Live attenuated rMERS-CoV-ΔE Recombinant MERS-CoV without E In vitro — Universidad Autonoma de Madrid, Spain 90 Open in a separate window MERS-CoV vaccines under development.
Article Title: Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial
Article Snippet: The Research Monitor will provide an unbiased written report of all unanticipated problems involving risks to participants or others, and related SAEs and deaths, within 10 working days to the WRAIR IRB by email (Usarmy.detrick.medcom-wrair.mbx.hspb@mail.mil), or by mail at the following address: Walter Reed Army Institute of Research, ATTN: Human Subjects Protection Branch, 503 Robert Grant Ave, Silver Spring, MD 20910.
Article Title: Harnessing Recent Advances in Synthetic DNA and Electroporation Technologies for Rapid Vaccine Development Against COVID-19 and Other Emerging Infectious Diseases
Article Snippet: MERS , GLS-5300 , MERS S protein , Phase I , NCT02670187 , IM-EP , GeneOne Life Science; Inovio Pharmaceuticals , Yes , 94 and 50% subjects developed binding and neutralizing antibody responses by the third vaccination , 76% Subjects developed T-cell responses by the third vaccination , ( ) .
Article Title: Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial
Article Snippet: GLS-5300 GeneOne Life Science, Inc. Clinical Protocol Date:13Nov2017 v10.0 -36-
Article Title: Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial
Article Snippet: U.S. BB-IND 16711 Version 10.0 GLS-5300 GeneOne Life Science, Inc. WRAIR 2274, HRPO Log A#19272 Clinical Protocol V10.0 -- Date: 13Nov2017 PHASE I, OPEN-LABEL, DOSE RANGING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF GLS-5300, ADMINISTERED IM FOLLOWED BY ELECTROPORATION IN HEALTHY VOLUNTEERS Drug: GLS-5300 Protocol Number: WRAIR #2274 Sponsor: GeneOne Life Science, Inc. 1040 DeKalb Pike, Suite 200 Blue Bell, PA 19422 Principal Investigator Kayvon Modjarrad, MD, PhD Sponsor Medical Monitor: Joel Maslow, MD PhD MBA FACP Institutional Review Boards WRAIR Institutional Review Board (IRB) Walter Reed Army Institute of Research 503 Robert Grant Avenue Silver Spring, Maryland 20910-7500 Telephone: 301-319-9940 / Fax: 301-319-9961 Email: usarmy.detrick.medcom-wrair.list.humansubjects-protection@mail.mil FWA#: 00000015; IRB#: 00000794 Version and Date: Version 10.0 13Nov2017 CONFIDENTIAL The information in this document is considered privileged and confidential by GeneOne Life Science, Inc. and may not be disclosed to others except to the extent necessary to obtain Institutional Review Board/Ethics committee approval and informed consent, or as required by local regulatory authorities.
Article Title: Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial
Article Snippet: GLS-5300 GeneOne Life Science, Inc. Clinical Protocol Date:13Nov2017 v10.0 -33-
Article Title: Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial
Article Snippet: GLS-5300 GeneOne Life Science, Inc. Clinical Protocol Date:13Nov2017 v10.0 -44-
Activity Assay:Article Title: Potential Rapid Diagnostics, Vaccine and Therapeutics for 2019 Novel Coronavirus (2019-nCoV): A Systematic Review
Article Snippet: 4 , GeneOne Life Science and Inovio Pharmaceuticals; GLS-5300 , United States (Maryland) Phase I clinical trial; Open-label, single-arm, dose-escalation study; 3 doses of 0·67 mg, 2 mg, or 6 mg GLS-5300; intramuscular 1 mL injection followed immediately by co-localised intramuscular electroporation with CELLECTRA ® -5P device at week 0, 4 and 12 with follow-up through to 48 weeks after dose 3 , 75 healthy adults between 18 and 50 years old (mean age 32.2 years), with normal screening electrocardiogram, screening laboratory findings within normal limits or be grade 0–1 findings, and have no history of clinically significant immunosuppressive or autoimmune disease, HIV, hepatitis B or C virus infection; 25 subjects were randomised into each dose group and 65 subjects completed the study, and per protocol analysis was used. , No vaccine-associated serious adverse events. 97% participants reported at least one solicited adverse event, but most solicited symptoms were reported as mild and were self-limiting (19 [76%] with 0·67 mg, 20 [80%] with 2 mg, and 17 [68%] with 6 mg); injection site reactions were the most common adverse event [92%]. , Seroconversion measured by S1-ELISA occurred in 86% and 94% participants after 2 and 3 doses, respectively, and was maintained in 79% participants up to study end at week 60. Neutralising antibodies were detected in 50% participants at one or more time points during the study, but only 3% maintained neutralisation activity to end of study. T-cell responses were detected in 71% and 76% participants after 2 and 3 doses, respectively. There were no differences in immune responses between dose groups after 6 weeks and vaccine-induced humoral and cellular responses were respectively detected in 77% and 64% participants at week 60. , [ ] .
Article Title: Development of Middle East Respiratory Syndrome Coronavirus vaccines – advances and challenges
Article Snippet: Vaccine candidates under development are listed in and include: DNA vaccines, protein subunit and peptide vaccines, vector-based vaccines, and live attenuated vaccines. table ft1 table-wrap mode="anchored" t5 Table 1. caption a7 Vaccine platform Vaccine name Viral antigen/Product design Status Animal models Institution Ref. DNA GLS-5300 Full-length S Phase I C57BL/6 mice, camels, rhesus GeneOne Life Science, South Korea 53 Protein subunit S-RBD-Fc S1-RBD fused with human Fc Preclinical BALB/c mice, rabbits, hDPP4-mice New York Blood Center, U.S.A., Fudan University, China 47,69 MERS-CoV rRBD Truncated S1-RBD Preclinical BALB/c mice China CDC 59 rNTD rNTD Preclinical BALB/c mice China CDC 70 MERS-S Nanoparticles Preclinical BALB/c mice Novavax, U.S.A. 74,75 Heterologous prime-boost S-DNA/S1 Protein Full-length S (prime) + S1 subunit (boost) Preclinical BALB/c mice, Rhesus U.S. National Institute of Health 55 Vector ChAdOx1-MERS-S Full-length S Preclinical Mice Jenner Institute, UK 84,99 Ad5-S, Ad41-S Full-length S Preclinical Mice China CDC 79 BNSP333-S1 RABV-S1 Preclinical hDPP4-mice Thomas Jefferson Univ., Univ. of Maryland, NIH, U.S.A. 100 MERS-S/MERS-solS Measles-full-length S/solS Preclinical IFNAR-/-mice Paul Ehrlich Institute 78 GreMERSfi Ad5-full-length S/S1 Preclinical BALB/c Mice Greffex, U.S.A. 101 MVA-MERS-S Full-length S Preclinical hDPP4-mice, planning for phase I German Center for Infection Research (DIFZ) 80 Live attenuated rMERS-CoV-ΔE Recombinant MERS-CoV without E In vitro — Universidad Autonoma de Madrid, Spain 90 Open in a separate window MERS-CoV vaccines under development.
Article Title: Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial
Article Snippet: The Research Monitor will provide an unbiased written report of all unanticipated problems involving risks to participants or others, and related SAEs and deaths, within 10 working days to the WRAIR IRB by email (Usarmy.detrick.medcom-wrair.mbx.hspb@mail.mil), or by mail at the following address: Walter Reed Army Institute of Research, ATTN: Human Subjects Protection Branch, 503 Robert Grant Ave, Silver Spring, MD 20910.
Article Title: Harnessing Recent Advances in Synthetic DNA and Electroporation Technologies for Rapid Vaccine Development Against COVID-19 and Other Emerging Infectious Diseases
Article Snippet: MERS , GLS-5300 , MERS S protein , Phase I , NCT02670187 , IM-EP , GeneOne Life Science; Inovio Pharmaceuticals , Yes , 94 and 50% subjects developed binding and neutralizing antibody responses by the third vaccination , 76% Subjects developed T-cell responses by the third vaccination , ( ) .
Article Title: Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial
Article Snippet: GLS-5300 GeneOne Life Science, Inc. Clinical Protocol Date:13Nov2017 v10.0 -36-
Article Title: Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial
Article Snippet: U.S. BB-IND 16711 Version 10.0 GLS-5300 GeneOne Life Science, Inc. WRAIR 2274, HRPO Log A#19272 Clinical Protocol V10.0 -- Date: 13Nov2017 PHASE I, OPEN-LABEL, DOSE RANGING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF GLS-5300, ADMINISTERED IM FOLLOWED BY ELECTROPORATION IN HEALTHY VOLUNTEERS Drug: GLS-5300 Protocol Number: WRAIR #2274 Sponsor: GeneOne Life Science, Inc. 1040 DeKalb Pike, Suite 200 Blue Bell, PA 19422 Principal Investigator Kayvon Modjarrad, MD, PhD Sponsor Medical Monitor: Joel Maslow, MD PhD MBA FACP Institutional Review Boards WRAIR Institutional Review Board (IRB) Walter Reed Army Institute of Research 503 Robert Grant Avenue Silver Spring, Maryland 20910-7500 Telephone: 301-319-9940 / Fax: 301-319-9961 Email: usarmy.detrick.medcom-wrair.list.humansubjects-protection@mail.mil FWA#: 00000015; IRB#: 00000794 Version and Date: Version 10.0 13Nov2017 CONFIDENTIAL The information in this document is considered privileged and confidential by GeneOne Life Science, Inc. and may not be disclosed to others except to the extent necessary to obtain Institutional Review Board/Ethics committee approval and informed consent, or as required by local regulatory authorities.
Article Title: Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial
Article Snippet: GLS-5300 GeneOne Life Science, Inc. Clinical Protocol Date:13Nov2017 v10.0 -33-
Article Title: Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial
Article Snippet: GLS-5300 GeneOne Life Science, Inc. Clinical Protocol Date:13Nov2017 v10.0 -44-
Immunopeptidomics:Article Title: Potential Rapid Diagnostics, Vaccine and Therapeutics for 2019 Novel Coronavirus (2019-nCoV): A Systematic Review
Article Snippet: 4 , GeneOne Life Science and Inovio Pharmaceuticals; GLS-5300 , United States (Maryland) Phase I clinical trial; Open-label, single-arm, dose-escalation study; 3 doses of 0·67 mg, 2 mg, or 6 mg GLS-5300; intramuscular 1 mL injection followed immediately by co-localised intramuscular electroporation with CELLECTRA ® -5P device at week 0, 4 and 12 with follow-up through to 48 weeks after dose 3 , 75 healthy adults between 18 and 50 years old (mean age 32.2 years), with normal screening electrocardiogram, screening laboratory findings within normal limits or be grade 0–1 findings, and have no history of clinically significant immunosuppressive or autoimmune disease, HIV, hepatitis B or C virus infection; 25 subjects were randomised into each dose group and 65 subjects completed the study, and per protocol analysis was used. , No vaccine-associated serious adverse events. 97% participants reported at least one solicited adverse event, but most solicited symptoms were reported as mild and were self-limiting (19 [76%] with 0·67 mg, 20 [80%] with 2 mg, and 17 [68%] with 6 mg); injection site reactions were the most common adverse event [92%]. , Seroconversion measured by S1-ELISA occurred in 86% and 94% participants after 2 and 3 doses, respectively, and was maintained in 79% participants up to study end at week 60. Neutralising antibodies were detected in 50% participants at one or more time points during the study, but only 3% maintained neutralisation activity to end of study. T-cell responses were detected in 71% and 76% participants after 2 and 3 doses, respectively. There were no differences in immune responses between dose groups after 6 weeks and vaccine-induced humoral and cellular responses were respectively detected in 77% and 64% participants at week 60. , [ ] .
Article Title: Development of Middle East Respiratory Syndrome Coronavirus vaccines – advances and challenges
Article Snippet: Vaccine candidates under development are listed in and include: DNA vaccines, protein subunit and peptide vaccines, vector-based vaccines, and live attenuated vaccines. table ft1 table-wrap mode="anchored" t5 Table 1. caption a7 Vaccine platform Vaccine name Viral antigen/Product design Status Animal models Institution Ref. DNA GLS-5300 Full-length S Phase I C57BL/6 mice, camels, rhesus GeneOne Life Science, South Korea 53 Protein subunit S-RBD-Fc S1-RBD fused with human Fc Preclinical BALB/c mice, rabbits, hDPP4-mice New York Blood Center, U.S.A., Fudan University, China 47,69 MERS-CoV rRBD Truncated S1-RBD Preclinical BALB/c mice China CDC 59 rNTD rNTD Preclinical BALB/c mice China CDC 70 MERS-S Nanoparticles Preclinical BALB/c mice Novavax, U.S.A. 74,75 Heterologous prime-boost S-DNA/S1 Protein Full-length S (prime) + S1 subunit (boost) Preclinical BALB/c mice, Rhesus U.S. National Institute of Health 55 Vector ChAdOx1-MERS-S Full-length S Preclinical Mice Jenner Institute, UK 84,99 Ad5-S, Ad41-S Full-length S Preclinical Mice China CDC 79 BNSP333-S1 RABV-S1 Preclinical hDPP4-mice Thomas Jefferson Univ., Univ. of Maryland, NIH, U.S.A. 100 MERS-S/MERS-solS Measles-full-length S/solS Preclinical IFNAR-/-mice Paul Ehrlich Institute 78 GreMERSfi Ad5-full-length S/S1 Preclinical BALB/c Mice Greffex, U.S.A. 101 MVA-MERS-S Full-length S Preclinical hDPP4-mice, planning for phase I German Center for Infection Research (DIFZ) 80 Live attenuated rMERS-CoV-ΔE Recombinant MERS-CoV without E In vitro — Universidad Autonoma de Madrid, Spain 90 Open in a separate window MERS-CoV vaccines under development.
Article Title: Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial
Article Snippet: The Research Monitor will provide an unbiased written report of all unanticipated problems involving risks to participants or others, and related SAEs and deaths, within 10 working days to the WRAIR IRB by email (Usarmy.detrick.medcom-wrair.mbx.hspb@mail.mil), or by mail at the following address: Walter Reed Army Institute of Research, ATTN: Human Subjects Protection Branch, 503 Robert Grant Ave, Silver Spring, MD 20910.
Article Title: Harnessing Recent Advances in Synthetic DNA and Electroporation Technologies for Rapid Vaccine Development Against COVID-19 and Other Emerging Infectious Diseases
Article Snippet: MERS , GLS-5300 , MERS S protein , Phase I , NCT02670187 , IM-EP , GeneOne Life Science; Inovio Pharmaceuticals , Yes , 94 and 50% subjects developed binding and neutralizing antibody responses by the third vaccination , 76% Subjects developed T-cell responses by the third vaccination , ( ) .
Article Title: Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial
Article Snippet: GLS-5300 GeneOne Life Science, Inc. Clinical Protocol Date:13Nov2017 v10.0 -36-
Article Title: Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial
Article Snippet: U.S. BB-IND 16711 Version 10.0 GLS-5300 GeneOne Life Science, Inc. WRAIR 2274, HRPO Log A#19272 Clinical Protocol V10.0 -- Date: 13Nov2017 PHASE I, OPEN-LABEL, DOSE RANGING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF GLS-5300, ADMINISTERED IM FOLLOWED BY ELECTROPORATION IN HEALTHY VOLUNTEERS Drug: GLS-5300 Protocol Number: WRAIR #2274 Sponsor: GeneOne Life Science, Inc. 1040 DeKalb Pike, Suite 200 Blue Bell, PA 19422 Principal Investigator Kayvon Modjarrad, MD, PhD Sponsor Medical Monitor: Joel Maslow, MD PhD MBA FACP Institutional Review Boards WRAIR Institutional Review Board (IRB) Walter Reed Army Institute of Research 503 Robert Grant Avenue Silver Spring, Maryland 20910-7500 Telephone: 301-319-9940 / Fax: 301-319-9961 Email: usarmy.detrick.medcom-wrair.list.humansubjects-protection@mail.mil FWA#: 00000015; IRB#: 00000794 Version and Date: Version 10.0 13Nov2017 CONFIDENTIAL The information in this document is considered privileged and confidential by GeneOne Life Science, Inc. and may not be disclosed to others except to the extent necessary to obtain Institutional Review Board/Ethics committee approval and informed consent, or as required by local regulatory authorities.
Article Title: Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial
Article Snippet: GLS-5300 GeneOne Life Science, Inc. Clinical Protocol Date:13Nov2017 v10.0 -33-
Article Title: Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial
Article Snippet: GLS-5300 GeneOne Life Science, Inc. Clinical Protocol Date:13Nov2017 v10.0 -44-
Isolation:Article Title: Potential Rapid Diagnostics, Vaccine and Therapeutics for 2019 Novel Coronavirus (2019-nCoV): A Systematic Review
Article Snippet: 4 , GeneOne Life Science and Inovio Pharmaceuticals; GLS-5300 , United States (Maryland) Phase I clinical trial; Open-label, single-arm, dose-escalation study; 3 doses of 0·67 mg, 2 mg, or 6 mg GLS-5300; intramuscular 1 mL injection followed immediately by co-localised intramuscular electroporation with CELLECTRA ® -5P device at week 0, 4 and 12 with follow-up through to 48 weeks after dose 3 , 75 healthy adults between 18 and 50 years old (mean age 32.2 years), with normal screening electrocardiogram, screening laboratory findings within normal limits or be grade 0–1 findings, and have no history of clinically significant immunosuppressive or autoimmune disease, HIV, hepatitis B or C virus infection; 25 subjects were randomised into each dose group and 65 subjects completed the study, and per protocol analysis was used. , No vaccine-associated serious adverse events. 97% participants reported at least one solicited adverse event, but most solicited symptoms were reported as mild and were self-limiting (19 [76%] with 0·67 mg, 20 [80%] with 2 mg, and 17 [68%] with 6 mg); injection site reactions were the most common adverse event [92%]. , Seroconversion measured by S1-ELISA occurred in 86% and 94% participants after 2 and 3 doses, respectively, and was maintained in 79% participants up to study end at week 60. Neutralising antibodies were detected in 50% participants at one or more time points during the study, but only 3% maintained neutralisation activity to end of study. T-cell responses were detected in 71% and 76% participants after 2 and 3 doses, respectively. There were no differences in immune responses between dose groups after 6 weeks and vaccine-induced humoral and cellular responses were respectively detected in 77% and 64% participants at week 60. , [ ] .
Article Title: Development of Middle East Respiratory Syndrome Coronavirus vaccines – advances and challenges
Article Snippet: Vaccine candidates under development are listed in and include: DNA vaccines, protein subunit and peptide vaccines, vector-based vaccines, and live attenuated vaccines. table ft1 table-wrap mode="anchored" t5 Table 1. caption a7 Vaccine platform Vaccine name Viral antigen/Product design Status Animal models Institution Ref. DNA GLS-5300 Full-length S Phase I C57BL/6 mice, camels, rhesus GeneOne Life Science, South Korea 53 Protein subunit S-RBD-Fc S1-RBD fused with human Fc Preclinical BALB/c mice, rabbits, hDPP4-mice New York Blood Center, U.S.A., Fudan University, China 47,69 MERS-CoV rRBD Truncated S1-RBD Preclinical BALB/c mice China CDC 59 rNTD rNTD Preclinical BALB/c mice China CDC 70 MERS-S Nanoparticles Preclinical BALB/c mice Novavax, U.S.A. 74,75 Heterologous prime-boost S-DNA/S1 Protein Full-length S (prime) + S1 subunit (boost) Preclinical BALB/c mice, Rhesus U.S. National Institute of Health 55 Vector ChAdOx1-MERS-S Full-length S Preclinical Mice Jenner Institute, UK 84,99 Ad5-S, Ad41-S Full-length S Preclinical Mice China CDC 79 BNSP333-S1 RABV-S1 Preclinical hDPP4-mice Thomas Jefferson Univ., Univ. of Maryland, NIH, U.S.A. 100 MERS-S/MERS-solS Measles-full-length S/solS Preclinical IFNAR-/-mice Paul Ehrlich Institute 78 GreMERSfi Ad5-full-length S/S1 Preclinical BALB/c Mice Greffex, U.S.A. 101 MVA-MERS-S Full-length S Preclinical hDPP4-mice, planning for phase I German Center for Infection Research (DIFZ) 80 Live attenuated rMERS-CoV-ΔE Recombinant MERS-CoV without E In vitro — Universidad Autonoma de Madrid, Spain 90 Open in a separate window MERS-CoV vaccines under development.
Article Title: Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial
Article Snippet: The Research Monitor will provide an unbiased written report of all unanticipated problems involving risks to participants or others, and related SAEs and deaths, within 10 working days to the WRAIR IRB by email (Usarmy.detrick.medcom-wrair.mbx.hspb@mail.mil), or by mail at the following address: Walter Reed Army Institute of Research, ATTN: Human Subjects Protection Branch, 503 Robert Grant Ave, Silver Spring, MD 20910.
Article Title: Harnessing Recent Advances in Synthetic DNA and Electroporation Technologies for Rapid Vaccine Development Against COVID-19 and Other Emerging Infectious Diseases
Article Snippet: MERS , GLS-5300 , MERS S protein , Phase I , NCT02670187 , IM-EP , GeneOne Life Science; Inovio Pharmaceuticals , Yes , 94 and 50% subjects developed binding and neutralizing antibody responses by the third vaccination , 76% Subjects developed T-cell responses by the third vaccination , ( ) .
Article Title: Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial
Article Snippet: GLS-5300 GeneOne Life Science, Inc. Clinical Protocol Date:13Nov2017 v10.0 -36-
Article Title: Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial
Article Snippet: U.S. BB-IND 16711 Version 10.0 GLS-5300 GeneOne Life Science, Inc. WRAIR 2274, HRPO Log A#19272 Clinical Protocol V10.0 -- Date: 13Nov2017 PHASE I, OPEN-LABEL, DOSE RANGING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF GLS-5300, ADMINISTERED IM FOLLOWED BY ELECTROPORATION IN HEALTHY VOLUNTEERS Drug: GLS-5300 Protocol Number: WRAIR #2274 Sponsor: GeneOne Life Science, Inc. 1040 DeKalb Pike, Suite 200 Blue Bell, PA 19422 Principal Investigator Kayvon Modjarrad, MD, PhD Sponsor Medical Monitor: Joel Maslow, MD PhD MBA FACP Institutional Review Boards WRAIR Institutional Review Board (IRB) Walter Reed Army Institute of Research 503 Robert Grant Avenue Silver Spring, Maryland 20910-7500 Telephone: 301-319-9940 / Fax: 301-319-9961 Email: usarmy.detrick.medcom-wrair.list.humansubjects-protection@mail.mil FWA#: 00000015; IRB#: 00000794 Version and Date: Version 10.0 13Nov2017 CONFIDENTIAL The information in this document is considered privileged and confidential by GeneOne Life Science, Inc. and may not be disclosed to others except to the extent necessary to obtain Institutional Review Board/Ethics committee approval and informed consent, or as required by local regulatory authorities.
Article Title: Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial
Article Snippet: GLS-5300 GeneOne Life Science, Inc. Clinical Protocol Date:13Nov2017 v10.0 -33-
Article Title: Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial
Article Snippet: GLS-5300 GeneOne Life Science, Inc. Clinical Protocol Date:13Nov2017 v10.0 -44-
Transmission Assay:Article Title: Potential Rapid Diagnostics, Vaccine and Therapeutics for 2019 Novel Coronavirus (2019-nCoV): A Systematic Review
Article Snippet: 4 , GeneOne Life Science and Inovio Pharmaceuticals; GLS-5300 , United States (Maryland) Phase I clinical trial; Open-label, single-arm, dose-escalation study; 3 doses of 0·67 mg, 2 mg, or 6 mg GLS-5300; intramuscular 1 mL injection followed immediately by co-localised intramuscular electroporation with CELLECTRA ® -5P device at week 0, 4 and 12 with follow-up through to 48 weeks after dose 3 , 75 healthy adults between 18 and 50 years old (mean age 32.2 years), with normal screening electrocardiogram, screening laboratory findings within normal limits or be grade 0–1 findings, and have no history of clinically significant immunosuppressive or autoimmune disease, HIV, hepatitis B or C virus infection; 25 subjects were randomised into each dose group and 65 subjects completed the study, and per protocol analysis was used. , No vaccine-associated serious adverse events. 97% participants reported at least one solicited adverse event, but most solicited symptoms were reported as mild and were self-limiting (19 [76%] with 0·67 mg, 20 [80%] with 2 mg, and 17 [68%] with 6 mg); injection site reactions were the most common adverse event [92%]. , Seroconversion measured by S1-ELISA occurred in 86% and 94% participants after 2 and 3 doses, respectively, and was maintained in 79% participants up to study end at week 60. Neutralising antibodies were detected in 50% participants at one or more time points during the study, but only 3% maintained neutralisation activity to end of study. T-cell responses were detected in 71% and 76% participants after 2 and 3 doses, respectively. There were no differences in immune responses between dose groups after 6 weeks and vaccine-induced humoral and cellular responses were respectively detected in 77% and 64% participants at week 60. , [ ] .
Article Title: Development of Middle East Respiratory Syndrome Coronavirus vaccines – advances and challenges
Article Snippet: Vaccine candidates under development are listed in and include: DNA vaccines, protein subunit and peptide vaccines, vector-based vaccines, and live attenuated vaccines. table ft1 table-wrap mode="anchored" t5 Table 1. caption a7 Vaccine platform Vaccine name Viral antigen/Product design Status Animal models Institution Ref. DNA GLS-5300 Full-length S Phase I C57BL/6 mice, camels, rhesus GeneOne Life Science, South Korea 53 Protein subunit S-RBD-Fc S1-RBD fused with human Fc Preclinical BALB/c mice, rabbits, hDPP4-mice New York Blood Center, U.S.A., Fudan University, China 47,69 MERS-CoV rRBD Truncated S1-RBD Preclinical BALB/c mice China CDC 59 rNTD rNTD Preclinical BALB/c mice China CDC 70 MERS-S Nanoparticles Preclinical BALB/c mice Novavax, U.S.A. 74,75 Heterologous prime-boost S-DNA/S1 Protein Full-length S (prime) + S1 subunit (boost) Preclinical BALB/c mice, Rhesus U.S. National Institute of Health 55 Vector ChAdOx1-MERS-S Full-length S Preclinical Mice Jenner Institute, UK 84,99 Ad5-S, Ad41-S Full-length S Preclinical Mice China CDC 79 BNSP333-S1 RABV-S1 Preclinical hDPP4-mice Thomas Jefferson Univ., Univ. of Maryland, NIH, U.S.A. 100 MERS-S/MERS-solS Measles-full-length S/solS Preclinical IFNAR-/-mice Paul Ehrlich Institute 78 GreMERSfi Ad5-full-length S/S1 Preclinical BALB/c Mice Greffex, U.S.A. 101 MVA-MERS-S Full-length S Preclinical hDPP4-mice, planning for phase I German Center for Infection Research (DIFZ) 80 Live attenuated rMERS-CoV-ΔE Recombinant MERS-CoV without E In vitro — Universidad Autonoma de Madrid, Spain 90 Open in a separate window MERS-CoV vaccines under development.
Article Title: Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial
Article Snippet: The Research Monitor will provide an unbiased written report of all unanticipated problems involving risks to participants or others, and related SAEs and deaths, within 10 working days to the WRAIR IRB by email (Usarmy.detrick.medcom-wrair.mbx.hspb@mail.mil), or by mail at the following address: Walter Reed Army Institute of Research, ATTN: Human Subjects Protection Branch, 503 Robert Grant Ave, Silver Spring, MD 20910.
Article Title: Harnessing Recent Advances in Synthetic DNA and Electroporation Technologies for Rapid Vaccine Development Against COVID-19 and Other Emerging Infectious Diseases
Article Snippet: MERS , GLS-5300 , MERS S protein , Phase I , NCT02670187 , IM-EP , GeneOne Life Science; Inovio Pharmaceuticals , Yes , 94 and 50% subjects developed binding and neutralizing antibody responses by the third vaccination , 76% Subjects developed T-cell responses by the third vaccination , ( ) .
Article Title: Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial
Article Snippet: GLS-5300 GeneOne Life Science, Inc. Clinical Protocol Date:13Nov2017 v10.0 -36-
Article Title: Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial
Article Snippet: U.S. BB-IND 16711 Version 10.0 GLS-5300 GeneOne Life Science, Inc. WRAIR 2274, HRPO Log A#19272 Clinical Protocol V10.0 -- Date: 13Nov2017 PHASE I, OPEN-LABEL, DOSE RANGING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF GLS-5300, ADMINISTERED IM FOLLOWED BY ELECTROPORATION IN HEALTHY VOLUNTEERS Drug: GLS-5300 Protocol Number: WRAIR #2274 Sponsor: GeneOne Life Science, Inc. 1040 DeKalb Pike, Suite 200 Blue Bell, PA 19422 Principal Investigator Kayvon Modjarrad, MD, PhD Sponsor Medical Monitor: Joel Maslow, MD PhD MBA FACP Institutional Review Boards WRAIR Institutional Review Board (IRB) Walter Reed Army Institute of Research 503 Robert Grant Avenue Silver Spring, Maryland 20910-7500 Telephone: 301-319-9940 / Fax: 301-319-9961 Email: usarmy.detrick.medcom-wrair.list.humansubjects-protection@mail.mil FWA#: 00000015; IRB#: 00000794 Version and Date: Version 10.0 13Nov2017 CONFIDENTIAL The information in this document is considered privileged and confidential by GeneOne Life Science, Inc. and may not be disclosed to others except to the extent necessary to obtain Institutional Review Board/Ethics committee approval and informed consent, or as required by local regulatory authorities.
Article Title: Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial
Article Snippet: GLS-5300 GeneOne Life Science, Inc. Clinical Protocol Date:13Nov2017 v10.0 -33-
Article Title: Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial
Article Snippet: GLS-5300 GeneOne Life Science, Inc. Clinical Protocol Date:13Nov2017 v10.0 -44-
Sterility:Article Title: Potential Rapid Diagnostics, Vaccine and Therapeutics for 2019 Novel Coronavirus (2019-nCoV): A Systematic Review
Article Snippet: 4 , GeneOne Life Science and Inovio Pharmaceuticals; GLS-5300 , United States (Maryland) Phase I clinical trial; Open-label, single-arm, dose-escalation study; 3 doses of 0·67 mg, 2 mg, or 6 mg GLS-5300; intramuscular 1 mL injection followed immediately by co-localised intramuscular electroporation with CELLECTRA ® -5P device at week 0, 4 and 12 with follow-up through to 48 weeks after dose 3 , 75 healthy adults between 18 and 50 years old (mean age 32.2 years), with normal screening electrocardiogram, screening laboratory findings within normal limits or be grade 0–1 findings, and have no history of clinically significant immunosuppressive or autoimmune disease, HIV, hepatitis B or C virus infection; 25 subjects were randomised into each dose group and 65 subjects completed the study, and per protocol analysis was used. , No vaccine-associated serious adverse events. 97% participants reported at least one solicited adverse event, but most solicited symptoms were reported as mild and were self-limiting (19 [76%] with 0·67 mg, 20 [80%] with 2 mg, and 17 [68%] with 6 mg); injection site reactions were the most common adverse event [92%]. , Seroconversion measured by S1-ELISA occurred in 86% and 94% participants after 2 and 3 doses, respectively, and was maintained in 79% participants up to study end at week 60. Neutralising antibodies were detected in 50% participants at one or more time points during the study, but only 3% maintained neutralisation activity to end of study. T-cell responses were detected in 71% and 76% participants after 2 and 3 doses, respectively. There were no differences in immune responses between dose groups after 6 weeks and vaccine-induced humoral and cellular responses were respectively detected in 77% and 64% participants at week 60. , [ ] .
Article Title: Development of Middle East Respiratory Syndrome Coronavirus vaccines – advances and challenges
Article Snippet: Vaccine candidates under development are listed in and include: DNA vaccines, protein subunit and peptide vaccines, vector-based vaccines, and live attenuated vaccines. table ft1 table-wrap mode="anchored" t5 Table 1. caption a7 Vaccine platform Vaccine name Viral antigen/Product design Status Animal models Institution Ref. DNA GLS-5300 Full-length S Phase I C57BL/6 mice, camels, rhesus GeneOne Life Science, South Korea 53 Protein subunit S-RBD-Fc S1-RBD fused with human Fc Preclinical BALB/c mice, rabbits, hDPP4-mice New York Blood Center, U.S.A., Fudan University, China 47,69 MERS-CoV rRBD Truncated S1-RBD Preclinical BALB/c mice China CDC 59 rNTD rNTD Preclinical BALB/c mice China CDC 70 MERS-S Nanoparticles Preclinical BALB/c mice Novavax, U.S.A. 74,75 Heterologous prime-boost S-DNA/S1 Protein Full-length S (prime) + S1 subunit (boost) Preclinical BALB/c mice, Rhesus U.S. National Institute of Health 55 Vector ChAdOx1-MERS-S Full-length S Preclinical Mice Jenner Institute, UK 84,99 Ad5-S, Ad41-S Full-length S Preclinical Mice China CDC 79 BNSP333-S1 RABV-S1 Preclinical hDPP4-mice Thomas Jefferson Univ., Univ. of Maryland, NIH, U.S.A. 100 MERS-S/MERS-solS Measles-full-length S/solS Preclinical IFNAR-/-mice Paul Ehrlich Institute 78 GreMERSfi Ad5-full-length S/S1 Preclinical BALB/c Mice Greffex, U.S.A. 101 MVA-MERS-S Full-length S Preclinical hDPP4-mice, planning for phase I German Center for Infection Research (DIFZ) 80 Live attenuated rMERS-CoV-ΔE Recombinant MERS-CoV without E In vitro — Universidad Autonoma de Madrid, Spain 90 Open in a separate window MERS-CoV vaccines under development.
Article Title: Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial
Article Snippet: The Research Monitor will provide an unbiased written report of all unanticipated problems involving risks to participants or others, and related SAEs and deaths, within 10 working days to the WRAIR IRB by email (Usarmy.detrick.medcom-wrair.mbx.hspb@mail.mil), or by mail at the following address: Walter Reed Army Institute of Research, ATTN: Human Subjects Protection Branch, 503 Robert Grant Ave, Silver Spring, MD 20910.
Article Title: Harnessing Recent Advances in Synthetic DNA and Electroporation Technologies for Rapid Vaccine Development Against COVID-19 and Other Emerging Infectious Diseases
Article Snippet: MERS , GLS-5300 , MERS S protein , Phase I , NCT02670187 , IM-EP , GeneOne Life Science; Inovio Pharmaceuticals , Yes , 94 and 50% subjects developed binding and neutralizing antibody responses by the third vaccination , 76% Subjects developed T-cell responses by the third vaccination , ( ) .
Article Title: Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial
Article Snippet: GLS-5300 GeneOne Life Science, Inc. Clinical Protocol Date:13Nov2017 v10.0 -36-
Article Title: Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial
Article Snippet: U.S. BB-IND 16711 Version 10.0 GLS-5300 GeneOne Life Science, Inc. WRAIR 2274, HRPO Log A#19272 Clinical Protocol V10.0 -- Date: 13Nov2017 PHASE I, OPEN-LABEL, DOSE RANGING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF GLS-5300, ADMINISTERED IM FOLLOWED BY ELECTROPORATION IN HEALTHY VOLUNTEERS Drug: GLS-5300 Protocol Number: WRAIR #2274 Sponsor: GeneOne Life Science, Inc. 1040 DeKalb Pike, Suite 200 Blue Bell, PA 19422 Principal Investigator Kayvon Modjarrad, MD, PhD Sponsor Medical Monitor: Joel Maslow, MD PhD MBA FACP Institutional Review Boards WRAIR Institutional Review Board (IRB) Walter Reed Army Institute of Research 503 Robert Grant Avenue Silver Spring, Maryland 20910-7500 Telephone: 301-319-9940 / Fax: 301-319-9961 Email: usarmy.detrick.medcom-wrair.list.humansubjects-protection@mail.mil FWA#: 00000015; IRB#: 00000794 Version and Date: Version 10.0 13Nov2017 CONFIDENTIAL The information in this document is considered privileged and confidential by GeneOne Life Science, Inc. and may not be disclosed to others except to the extent necessary to obtain Institutional Review Board/Ethics committee approval and informed consent, or as required by local regulatory authorities.
Article Title: Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial
Article Snippet: GLS-5300 GeneOne Life Science, Inc. Clinical Protocol Date:13Nov2017 v10.0 -33-
Article Title: Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial
Article Snippet: GLS-5300 GeneOne Life Science, Inc. Clinical Protocol Date:13Nov2017 v10.0 -44-
Disruption:Article Title: Potential Rapid Diagnostics, Vaccine and Therapeutics for 2019 Novel Coronavirus (2019-nCoV): A Systematic Review
Article Snippet: 4 , GeneOne Life Science and Inovio Pharmaceuticals; GLS-5300 , United States (Maryland) Phase I clinical trial; Open-label, single-arm, dose-escalation study; 3 doses of 0·67 mg, 2 mg, or 6 mg GLS-5300; intramuscular 1 mL injection followed immediately by co-localised intramuscular electroporation with CELLECTRA ® -5P device at week 0, 4 and 12 with follow-up through to 48 weeks after dose 3 , 75 healthy adults between 18 and 50 years old (mean age 32.2 years), with normal screening electrocardiogram, screening laboratory findings within normal limits or be grade 0–1 findings, and have no history of clinically significant immunosuppressive or autoimmune disease, HIV, hepatitis B or C virus infection; 25 subjects were randomised into each dose group and 65 subjects completed the study, and per protocol analysis was used. , No vaccine-associated serious adverse events. 97% participants reported at least one solicited adverse event, but most solicited symptoms were reported as mild and were self-limiting (19 [76%] with 0·67 mg, 20 [80%] with 2 mg, and 17 [68%] with 6 mg); injection site reactions were the most common adverse event [92%]. , Seroconversion measured by S1-ELISA occurred in 86% and 94% participants after 2 and 3 doses, respectively, and was maintained in 79% participants up to study end at week 60. Neutralising antibodies were detected in 50% participants at one or more time points during the study, but only 3% maintained neutralisation activity to end of study. T-cell responses were detected in 71% and 76% participants after 2 and 3 doses, respectively. There were no differences in immune responses between dose groups after 6 weeks and vaccine-induced humoral and cellular responses were respectively detected in 77% and 64% participants at week 60. , [ ] .
Article Title: Development of Middle East Respiratory Syndrome Coronavirus vaccines – advances and challenges
Article Snippet: Vaccine candidates under development are listed in and include: DNA vaccines, protein subunit and peptide vaccines, vector-based vaccines, and live attenuated vaccines. table ft1 table-wrap mode="anchored" t5 Table 1. caption a7 Vaccine platform Vaccine name Viral antigen/Product design Status Animal models Institution Ref. DNA GLS-5300 Full-length S Phase I C57BL/6 mice, camels, rhesus GeneOne Life Science, South Korea 53 Protein subunit S-RBD-Fc S1-RBD fused with human Fc Preclinical BALB/c mice, rabbits, hDPP4-mice New York Blood Center, U.S.A., Fudan University, China 47,69 MERS-CoV rRBD Truncated S1-RBD Preclinical BALB/c mice China CDC 59 rNTD rNTD Preclinical BALB/c mice China CDC 70 MERS-S Nanoparticles Preclinical BALB/c mice Novavax, U.S.A. 74,75 Heterologous prime-boost S-DNA/S1 Protein Full-length S (prime) + S1 subunit (boost) Preclinical BALB/c mice, Rhesus U.S. National Institute of Health 55 Vector ChAdOx1-MERS-S Full-length S Preclinical Mice Jenner Institute, UK 84,99 Ad5-S, Ad41-S Full-length S Preclinical Mice China CDC 79 BNSP333-S1 RABV-S1 Preclinical hDPP4-mice Thomas Jefferson Univ., Univ. of Maryland, NIH, U.S.A. 100 MERS-S/MERS-solS Measles-full-length S/solS Preclinical IFNAR-/-mice Paul Ehrlich Institute 78 GreMERSfi Ad5-full-length S/S1 Preclinical BALB/c Mice Greffex, U.S.A. 101 MVA-MERS-S Full-length S Preclinical hDPP4-mice, planning for phase I German Center for Infection Research (DIFZ) 80 Live attenuated rMERS-CoV-ΔE Recombinant MERS-CoV without E In vitro — Universidad Autonoma de Madrid, Spain 90 Open in a separate window MERS-CoV vaccines under development.
Article Title: Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial
Article Snippet: The Research Monitor will provide an unbiased written report of all unanticipated problems involving risks to participants or others, and related SAEs and deaths, within 10 working days to the WRAIR IRB by email (Usarmy.detrick.medcom-wrair.mbx.hspb@mail.mil), or by mail at the following address: Walter Reed Army Institute of Research, ATTN: Human Subjects Protection Branch, 503 Robert Grant Ave, Silver Spring, MD 20910.
Article Title: Harnessing Recent Advances in Synthetic DNA and Electroporation Technologies for Rapid Vaccine Development Against COVID-19 and Other Emerging Infectious Diseases
Article Snippet: MERS , GLS-5300 , MERS S protein , Phase I , NCT02670187 , IM-EP , GeneOne Life Science; Inovio Pharmaceuticals , Yes , 94 and 50% subjects developed binding and neutralizing antibody responses by the third vaccination , 76% Subjects developed T-cell responses by the third vaccination , ( ) .
Article Title: Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial
Article Snippet: GLS-5300 GeneOne Life Science, Inc. Clinical Protocol Date:13Nov2017 v10.0 -36-
Article Title: Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial
Article Snippet: U.S. BB-IND 16711 Version 10.0 GLS-5300 GeneOne Life Science, Inc. WRAIR 2274, HRPO Log A#19272 Clinical Protocol V10.0 -- Date: 13Nov2017 PHASE I, OPEN-LABEL, DOSE RANGING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF GLS-5300, ADMINISTERED IM FOLLOWED BY ELECTROPORATION IN HEALTHY VOLUNTEERS Drug: GLS-5300 Protocol Number: WRAIR #2274 Sponsor: GeneOne Life Science, Inc. 1040 DeKalb Pike, Suite 200 Blue Bell, PA 19422 Principal Investigator Kayvon Modjarrad, MD, PhD Sponsor Medical Monitor: Joel Maslow, MD PhD MBA FACP Institutional Review Boards WRAIR Institutional Review Board (IRB) Walter Reed Army Institute of Research 503 Robert Grant Avenue Silver Spring, Maryland 20910-7500 Telephone: 301-319-9940 / Fax: 301-319-9961 Email: usarmy.detrick.medcom-wrair.list.humansubjects-protection@mail.mil FWA#: 00000015; IRB#: 00000794 Version and Date: Version 10.0 13Nov2017 CONFIDENTIAL The information in this document is considered privileged and confidential by GeneOne Life Science, Inc. and may not be disclosed to others except to the extent necessary to obtain Institutional Review Board/Ethics committee approval and informed consent, or as required by local regulatory authorities.
Article Title: Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial
Article Snippet: GLS-5300 GeneOne Life Science, Inc. Clinical Protocol Date:13Nov2017 v10.0 -33-
Article Title: Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial
Article Snippet: GLS-5300 GeneOne Life Science, Inc. Clinical Protocol Date:13Nov2017 v10.0 -44-
Transplantation Assay:Article Title: Potential Rapid Diagnostics, Vaccine and Therapeutics for 2019 Novel Coronavirus (2019-nCoV): A Systematic Review
Article Snippet: 4 , GeneOne Life Science and Inovio Pharmaceuticals; GLS-5300 , United States (Maryland) Phase I clinical trial; Open-label, single-arm, dose-escalation study; 3 doses of 0·67 mg, 2 mg, or 6 mg GLS-5300; intramuscular 1 mL injection followed immediately by co-localised intramuscular electroporation with CELLECTRA ® -5P device at week 0, 4 and 12 with follow-up through to 48 weeks after dose 3 , 75 healthy adults between 18 and 50 years old (mean age 32.2 years), with normal screening electrocardiogram, screening laboratory findings within normal limits or be grade 0–1 findings, and have no history of clinically significant immunosuppressive or autoimmune disease, HIV, hepatitis B or C virus infection; 25 subjects were randomised into each dose group and 65 subjects completed the study, and per protocol analysis was used. , No vaccine-associated serious adverse events. 97% participants reported at least one solicited adverse event, but most solicited symptoms were reported as mild and were self-limiting (19 [76%] with 0·67 mg, 20 [80%] with 2 mg, and 17 [68%] with 6 mg); injection site reactions were the most common adverse event [92%]. , Seroconversion measured by S1-ELISA occurred in 86% and 94% participants after 2 and 3 doses, respectively, and was maintained in 79% participants up to study end at week 60. Neutralising antibodies were detected in 50% participants at one or more time points during the study, but only 3% maintained neutralisation activity to end of study. T-cell responses were detected in 71% and 76% participants after 2 and 3 doses, respectively. There were no differences in immune responses between dose groups after 6 weeks and vaccine-induced humoral and cellular responses were respectively detected in 77% and 64% participants at week 60. , [ ] .
Article Title: Development of Middle East Respiratory Syndrome Coronavirus vaccines – advances and challenges
Article Snippet: Vaccine candidates under development are listed in and include: DNA vaccines, protein subunit and peptide vaccines, vector-based vaccines, and live attenuated vaccines. table ft1 table-wrap mode="anchored" t5 Table 1. caption a7 Vaccine platform Vaccine name Viral antigen/Product design Status Animal models Institution Ref. DNA GLS-5300 Full-length S Phase I C57BL/6 mice, camels, rhesus GeneOne Life Science, South Korea 53 Protein subunit S-RBD-Fc S1-RBD fused with human Fc Preclinical BALB/c mice, rabbits, hDPP4-mice New York Blood Center, U.S.A., Fudan University, China 47,69 MERS-CoV rRBD Truncated S1-RBD Preclinical BALB/c mice China CDC 59 rNTD rNTD Preclinical BALB/c mice China CDC 70 MERS-S Nanoparticles Preclinical BALB/c mice Novavax, U.S.A. 74,75 Heterologous prime-boost S-DNA/S1 Protein Full-length S (prime) + S1 subunit (boost) Preclinical BALB/c mice, Rhesus U.S. National Institute of Health 55 Vector ChAdOx1-MERS-S Full-length S Preclinical Mice Jenner Institute, UK 84,99 Ad5-S, Ad41-S Full-length S Preclinical Mice China CDC 79 BNSP333-S1 RABV-S1 Preclinical hDPP4-mice Thomas Jefferson Univ., Univ. of Maryland, NIH, U.S.A. 100 MERS-S/MERS-solS Measles-full-length S/solS Preclinical IFNAR-/-mice Paul Ehrlich Institute 78 GreMERSfi Ad5-full-length S/S1 Preclinical BALB/c Mice Greffex, U.S.A. 101 MVA-MERS-S Full-length S Preclinical hDPP4-mice, planning for phase I German Center for Infection Research (DIFZ) 80 Live attenuated rMERS-CoV-ΔE Recombinant MERS-CoV without E In vitro — Universidad Autonoma de Madrid, Spain 90 Open in a separate window MERS-CoV vaccines under development.
Article Title: Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial
Article Snippet: The Research Monitor will provide an unbiased written report of all unanticipated problems involving risks to participants or others, and related SAEs and deaths, within 10 working days to the WRAIR IRB by email (Usarmy.detrick.medcom-wrair.mbx.hspb@mail.mil), or by mail at the following address: Walter Reed Army Institute of Research, ATTN: Human Subjects Protection Branch, 503 Robert Grant Ave, Silver Spring, MD 20910.
Article Title: Harnessing Recent Advances in Synthetic DNA and Electroporation Technologies for Rapid Vaccine Development Against COVID-19 and Other Emerging Infectious Diseases
Article Snippet: MERS , GLS-5300 , MERS S protein , Phase I , NCT02670187 , IM-EP , GeneOne Life Science; Inovio Pharmaceuticals , Yes , 94 and 50% subjects developed binding and neutralizing antibody responses by the third vaccination , 76% Subjects developed T-cell responses by the third vaccination , ( ) .
Article Title: Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial
Article Snippet: GLS-5300 GeneOne Life Science, Inc. Clinical Protocol Date:13Nov2017 v10.0 -36-
Article Title: Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial
Article Snippet: U.S. BB-IND 16711 Version 10.0 GLS-5300 GeneOne Life Science, Inc. WRAIR 2274, HRPO Log A#19272 Clinical Protocol V10.0 -- Date: 13Nov2017 PHASE I, OPEN-LABEL, DOSE RANGING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF GLS-5300, ADMINISTERED IM FOLLOWED BY ELECTROPORATION IN HEALTHY VOLUNTEERS Drug: GLS-5300 Protocol Number: WRAIR #2274 Sponsor: GeneOne Life Science, Inc. 1040 DeKalb Pike, Suite 200 Blue Bell, PA 19422 Principal Investigator Kayvon Modjarrad, MD, PhD Sponsor Medical Monitor: Joel Maslow, MD PhD MBA FACP Institutional Review Boards WRAIR Institutional Review Board (IRB) Walter Reed Army Institute of Research 503 Robert Grant Avenue Silver Spring, Maryland 20910-7500 Telephone: 301-319-9940 / Fax: 301-319-9961 Email: usarmy.detrick.medcom-wrair.list.humansubjects-protection@mail.mil FWA#: 00000015; IRB#: 00000794 Version and Date: Version 10.0 13Nov2017 CONFIDENTIAL The information in this document is considered privileged and confidential by GeneOne Life Science, Inc. and may not be disclosed to others except to the extent necessary to obtain Institutional Review Board/Ethics committee approval and informed consent, or as required by local regulatory authorities.
Article Title: Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial
Article Snippet: GLS-5300 GeneOne Life Science, Inc. Clinical Protocol Date:13Nov2017 v10.0 -33-
Article Title: Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial
Article Snippet: GLS-5300 GeneOne Life Science, Inc. Clinical Protocol Date:13Nov2017 v10.0 -44-
Medications:Article Title: Potential Rapid Diagnostics, Vaccine and Therapeutics for 2019 Novel Coronavirus (2019-nCoV): A Systematic Review
Article Snippet: 4 , GeneOne Life Science and Inovio Pharmaceuticals; GLS-5300 , United States (Maryland) Phase I clinical trial; Open-label, single-arm, dose-escalation study; 3 doses of 0·67 mg, 2 mg, or 6 mg GLS-5300; intramuscular 1 mL injection followed immediately by co-localised intramuscular electroporation with CELLECTRA ® -5P device at week 0, 4 and 12 with follow-up through to 48 weeks after dose 3 , 75 healthy adults between 18 and 50 years old (mean age 32.2 years), with normal screening electrocardiogram, screening laboratory findings within normal limits or be grade 0–1 findings, and have no history of clinically significant immunosuppressive or autoimmune disease, HIV, hepatitis B or C virus infection; 25 subjects were randomised into each dose group and 65 subjects completed the study, and per protocol analysis was used. , No vaccine-associated serious adverse events. 97% participants reported at least one solicited adverse event, but most solicited symptoms were reported as mild and were self-limiting (19 [76%] with 0·67 mg, 20 [80%] with 2 mg, and 17 [68%] with 6 mg); injection site reactions were the most common adverse event [92%]. , Seroconversion measured by S1-ELISA occurred in 86% and 94% participants after 2 and 3 doses, respectively, and was maintained in 79% participants up to study end at week 60. Neutralising antibodies were detected in 50% participants at one or more time points during the study, but only 3% maintained neutralisation activity to end of study. T-cell responses were detected in 71% and 76% participants after 2 and 3 doses, respectively. There were no differences in immune responses between dose groups after 6 weeks and vaccine-induced humoral and cellular responses were respectively detected in 77% and 64% participants at week 60. , [ ] .
Article Title: Development of Middle East Respiratory Syndrome Coronavirus vaccines – advances and challenges
Article Snippet: Vaccine candidates under development are listed in and include: DNA vaccines, protein subunit and peptide vaccines, vector-based vaccines, and live attenuated vaccines. table ft1 table-wrap mode="anchored" t5 Table 1. caption a7 Vaccine platform Vaccine name Viral antigen/Product design Status Animal models Institution Ref. DNA GLS-5300 Full-length S Phase I C57BL/6 mice, camels, rhesus GeneOne Life Science, South Korea 53 Protein subunit S-RBD-Fc S1-RBD fused with human Fc Preclinical BALB/c mice, rabbits, hDPP4-mice New York Blood Center, U.S.A., Fudan University, China 47,69 MERS-CoV rRBD Truncated S1-RBD Preclinical BALB/c mice China CDC 59 rNTD rNTD Preclinical BALB/c mice China CDC 70 MERS-S Nanoparticles Preclinical BALB/c mice Novavax, U.S.A. 74,75 Heterologous prime-boost S-DNA/S1 Protein Full-length S (prime) + S1 subunit (boost) Preclinical BALB/c mice, Rhesus U.S. National Institute of Health 55 Vector ChAdOx1-MERS-S Full-length S Preclinical Mice Jenner Institute, UK 84,99 Ad5-S, Ad41-S Full-length S Preclinical Mice China CDC 79 BNSP333-S1 RABV-S1 Preclinical hDPP4-mice Thomas Jefferson Univ., Univ. of Maryland, NIH, U.S.A. 100 MERS-S/MERS-solS Measles-full-length S/solS Preclinical IFNAR-/-mice Paul Ehrlich Institute 78 GreMERSfi Ad5-full-length S/S1 Preclinical BALB/c Mice Greffex, U.S.A. 101 MVA-MERS-S Full-length S Preclinical hDPP4-mice, planning for phase I German Center for Infection Research (DIFZ) 80 Live attenuated rMERS-CoV-ΔE Recombinant MERS-CoV without E In vitro — Universidad Autonoma de Madrid, Spain 90 Open in a separate window MERS-CoV vaccines under development.
Article Title: Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial
Article Snippet: The Research Monitor will provide an unbiased written report of all unanticipated problems involving risks to participants or others, and related SAEs and deaths, within 10 working days to the WRAIR IRB by email (Usarmy.detrick.medcom-wrair.mbx.hspb@mail.mil), or by mail at the following address: Walter Reed Army Institute of Research, ATTN: Human Subjects Protection Branch, 503 Robert Grant Ave, Silver Spring, MD 20910.
Article Title: Harnessing Recent Advances in Synthetic DNA and Electroporation Technologies for Rapid Vaccine Development Against COVID-19 and Other Emerging Infectious Diseases
Article Snippet: MERS , GLS-5300 , MERS S protein , Phase I , NCT02670187 , IM-EP , GeneOne Life Science; Inovio Pharmaceuticals , Yes , 94 and 50% subjects developed binding and neutralizing antibody responses by the third vaccination , 76% Subjects developed T-cell responses by the third vaccination , ( ) .
Article Title: Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial
Article Snippet: GLS-5300 GeneOne Life Science, Inc. Clinical Protocol Date:13Nov2017 v10.0 -36-
Article Title: Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial
Article Snippet: U.S. BB-IND 16711 Version 10.0 GLS-5300 GeneOne Life Science, Inc. WRAIR 2274, HRPO Log A#19272 Clinical Protocol V10.0 -- Date: 13Nov2017 PHASE I, OPEN-LABEL, DOSE RANGING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF GLS-5300, ADMINISTERED IM FOLLOWED BY ELECTROPORATION IN HEALTHY VOLUNTEERS Drug: GLS-5300 Protocol Number: WRAIR #2274 Sponsor: GeneOne Life Science, Inc. 1040 DeKalb Pike, Suite 200 Blue Bell, PA 19422 Principal Investigator Kayvon Modjarrad, MD, PhD Sponsor Medical Monitor: Joel Maslow, MD PhD MBA FACP Institutional Review Boards WRAIR Institutional Review Board (IRB) Walter Reed Army Institute of Research 503 Robert Grant Avenue Silver Spring, Maryland 20910-7500 Telephone: 301-319-9940 / Fax: 301-319-9961 Email: usarmy.detrick.medcom-wrair.list.humansubjects-protection@mail.mil FWA#: 00000015; IRB#: 00000794 Version and Date: Version 10.0 13Nov2017 CONFIDENTIAL The information in this document is considered privileged and confidential by GeneOne Life Science, Inc. and may not be disclosed to others except to the extent necessary to obtain Institutional Review Board/Ethics committee approval and informed consent, or as required by local regulatory authorities.
Article Title: Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial
Article Snippet: GLS-5300 GeneOne Life Science, Inc. Clinical Protocol Date:13Nov2017 v10.0 -33-
Article Title: Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial
Article Snippet: GLS-5300 GeneOne Life Science, Inc. Clinical Protocol Date:13Nov2017 v10.0 -44-
AST Assay:Article Title: Potential Rapid Diagnostics, Vaccine and Therapeutics for 2019 Novel Coronavirus (2019-nCoV): A Systematic Review
Article Snippet: 4 , GeneOne Life Science and Inovio Pharmaceuticals; GLS-5300 , United States (Maryland) Phase I clinical trial; Open-label, single-arm, dose-escalation study; 3 doses of 0·67 mg, 2 mg, or 6 mg GLS-5300; intramuscular 1 mL injection followed immediately by co-localised intramuscular electroporation with CELLECTRA ® -5P device at week 0, 4 and 12 with follow-up through to 48 weeks after dose 3 , 75 healthy adults between 18 and 50 years old (mean age 32.2 years), with normal screening electrocardiogram, screening laboratory findings within normal limits or be grade 0–1 findings, and have no history of clinically significant immunosuppressive or autoimmune disease, HIV, hepatitis B or C virus infection; 25 subjects were randomised into each dose group and 65 subjects completed the study, and per protocol analysis was used. , No vaccine-associated serious adverse events. 97% participants reported at least one solicited adverse event, but most solicited symptoms were reported as mild and were self-limiting (19 [76%] with 0·67 mg, 20 [80%] with 2 mg, and 17 [68%] with 6 mg); injection site reactions were the most common adverse event [92%]. , Seroconversion measured by S1-ELISA occurred in 86% and 94% participants after 2 and 3 doses, respectively, and was maintained in 79% participants up to study end at week 60. Neutralising antibodies were detected in 50% participants at one or more time points during the study, but only 3% maintained neutralisation activity to end of study. T-cell responses were detected in 71% and 76% participants after 2 and 3 doses, respectively. There were no differences in immune responses between dose groups after 6 weeks and vaccine-induced humoral and cellular responses were respectively detected in 77% and 64% participants at week 60. , [ ] .
Article Title: Development of Middle East Respiratory Syndrome Coronavirus vaccines – advances and challenges
Article Snippet: Vaccine candidates under development are listed in and include: DNA vaccines, protein subunit and peptide vaccines, vector-based vaccines, and live attenuated vaccines. table ft1 table-wrap mode="anchored" t5 Table 1. caption a7 Vaccine platform Vaccine name Viral antigen/Product design Status Animal models Institution Ref. DNA GLS-5300 Full-length S Phase I C57BL/6 mice, camels, rhesus GeneOne Life Science, South Korea 53 Protein subunit S-RBD-Fc S1-RBD fused with human Fc Preclinical BALB/c mice, rabbits, hDPP4-mice New York Blood Center, U.S.A., Fudan University, China 47,69 MERS-CoV rRBD Truncated S1-RBD Preclinical BALB/c mice China CDC 59 rNTD rNTD Preclinical BALB/c mice China CDC 70 MERS-S Nanoparticles Preclinical BALB/c mice Novavax, U.S.A. 74,75 Heterologous prime-boost S-DNA/S1 Protein Full-length S (prime) + S1 subunit (boost) Preclinical BALB/c mice, Rhesus U.S. National Institute of Health 55 Vector ChAdOx1-MERS-S Full-length S Preclinical Mice Jenner Institute, UK 84,99 Ad5-S, Ad41-S Full-length S Preclinical Mice China CDC 79 BNSP333-S1 RABV-S1 Preclinical hDPP4-mice Thomas Jefferson Univ., Univ. of Maryland, NIH, U.S.A. 100 MERS-S/MERS-solS Measles-full-length S/solS Preclinical IFNAR-/-mice Paul Ehrlich Institute 78 GreMERSfi Ad5-full-length S/S1 Preclinical BALB/c Mice Greffex, U.S.A. 101 MVA-MERS-S Full-length S Preclinical hDPP4-mice, planning for phase I German Center for Infection Research (DIFZ) 80 Live attenuated rMERS-CoV-ΔE Recombinant MERS-CoV without E In vitro — Universidad Autonoma de Madrid, Spain 90 Open in a separate window MERS-CoV vaccines under development.
Article Title: Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial
Article Snippet: The Research Monitor will provide an unbiased written report of all unanticipated problems involving risks to participants or others, and related SAEs and deaths, within 10 working days to the WRAIR IRB by email (Usarmy.detrick.medcom-wrair.mbx.hspb@mail.mil), or by mail at the following address: Walter Reed Army Institute of Research, ATTN: Human Subjects Protection Branch, 503 Robert Grant Ave, Silver Spring, MD 20910.
Article Title: Harnessing Recent Advances in Synthetic DNA and Electroporation Technologies for Rapid Vaccine Development Against COVID-19 and Other Emerging Infectious Diseases
Article Snippet: MERS , GLS-5300 , MERS S protein , Phase I , NCT02670187 , IM-EP , GeneOne Life Science; Inovio Pharmaceuticals , Yes , 94 and 50% subjects developed binding and neutralizing antibody responses by the third vaccination , 76% Subjects developed T-cell responses by the third vaccination , ( ) .
Article Title: Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial
Article Snippet: GLS-5300 GeneOne Life Science, Inc. Clinical Protocol Date:13Nov2017 v10.0 -36-
Article Title: Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial
Article Snippet: U.S. BB-IND 16711 Version 10.0 GLS-5300 GeneOne Life Science, Inc. WRAIR 2274, HRPO Log A#19272 Clinical Protocol V10.0 -- Date: 13Nov2017 PHASE I, OPEN-LABEL, DOSE RANGING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF GLS-5300, ADMINISTERED IM FOLLOWED BY ELECTROPORATION IN HEALTHY VOLUNTEERS Drug: GLS-5300 Protocol Number: WRAIR #2274 Sponsor: GeneOne Life Science, Inc. 1040 DeKalb Pike, Suite 200 Blue Bell, PA 19422 Principal Investigator Kayvon Modjarrad, MD, PhD Sponsor Medical Monitor: Joel Maslow, MD PhD MBA FACP Institutional Review Boards WRAIR Institutional Review Board (IRB) Walter Reed Army Institute of Research 503 Robert Grant Avenue Silver Spring, Maryland 20910-7500 Telephone: 301-319-9940 / Fax: 301-319-9961 Email: usarmy.detrick.medcom-wrair.list.humansubjects-protection@mail.mil FWA#: 00000015; IRB#: 00000794 Version and Date: Version 10.0 13Nov2017 CONFIDENTIAL The information in this document is considered privileged and confidential by GeneOne Life Science, Inc. and may not be disclosed to others except to the extent necessary to obtain Institutional Review Board/Ethics committee approval and informed consent, or as required by local regulatory authorities.
Article Title: Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial
Article Snippet: GLS-5300 GeneOne Life Science, Inc. Clinical Protocol Date:13Nov2017 v10.0 -33-
Article Title: Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial
Article Snippet: GLS-5300 GeneOne Life Science, Inc. Clinical Protocol Date:13Nov2017 v10.0 -44-
Pregnancy Test (hCG) Assay:Article Title: Potential Rapid Diagnostics, Vaccine and Therapeutics for 2019 Novel Coronavirus (2019-nCoV): A Systematic Review
Article Snippet: 4 , GeneOne Life Science and Inovio Pharmaceuticals; GLS-5300 , United States (Maryland) Phase I clinical trial; Open-label, single-arm, dose-escalation study; 3 doses of 0·67 mg, 2 mg, or 6 mg GLS-5300; intramuscular 1 mL injection followed immediately by co-localised intramuscular electroporation with CELLECTRA ® -5P device at week 0, 4 and 12 with follow-up through to 48 weeks after dose 3 , 75 healthy adults between 18 and 50 years old (mean age 32.2 years), with normal screening electrocardiogram, screening laboratory findings within normal limits or be grade 0–1 findings, and have no history of clinically significant immunosuppressive or autoimmune disease, HIV, hepatitis B or C virus infection; 25 subjects were randomised into each dose group and 65 subjects completed the study, and per protocol analysis was used. , No vaccine-associated serious adverse events. 97% participants reported at least one solicited adverse event, but most solicited symptoms were reported as mild and were self-limiting (19 [76%] with 0·67 mg, 20 [80%] with 2 mg, and 17 [68%] with 6 mg); injection site reactions were the most common adverse event [92%]. , Seroconversion measured by S1-ELISA occurred in 86% and 94% participants after 2 and 3 doses, respectively, and was maintained in 79% participants up to study end at week 60. Neutralising antibodies were detected in 50% participants at one or more time points during the study, but only 3% maintained neutralisation activity to end of study. T-cell responses were detected in 71% and 76% participants after 2 and 3 doses, respectively. There were no differences in immune responses between dose groups after 6 weeks and vaccine-induced humoral and cellular responses were respectively detected in 77% and 64% participants at week 60. , [ ] .
Article Title: Development of Middle East Respiratory Syndrome Coronavirus vaccines – advances and challenges
Article Snippet: Vaccine candidates under development are listed in and include: DNA vaccines, protein subunit and peptide vaccines, vector-based vaccines, and live attenuated vaccines. table ft1 table-wrap mode="anchored" t5 Table 1. caption a7 Vaccine platform Vaccine name Viral antigen/Product design Status Animal models Institution Ref. DNA GLS-5300 Full-length S Phase I C57BL/6 mice, camels, rhesus GeneOne Life Science, South Korea 53 Protein subunit S-RBD-Fc S1-RBD fused with human Fc Preclinical BALB/c mice, rabbits, hDPP4-mice New York Blood Center, U.S.A., Fudan University, China 47,69 MERS-CoV rRBD Truncated S1-RBD Preclinical BALB/c mice China CDC 59 rNTD rNTD Preclinical BALB/c mice China CDC 70 MERS-S Nanoparticles Preclinical BALB/c mice Novavax, U.S.A. 74,75 Heterologous prime-boost S-DNA/S1 Protein Full-length S (prime) + S1 subunit (boost) Preclinical BALB/c mice, Rhesus U.S. National Institute of Health 55 Vector ChAdOx1-MERS-S Full-length S Preclinical Mice Jenner Institute, UK 84,99 Ad5-S, Ad41-S Full-length S Preclinical Mice China CDC 79 BNSP333-S1 RABV-S1 Preclinical hDPP4-mice Thomas Jefferson Univ., Univ. of Maryland, NIH, U.S.A. 100 MERS-S/MERS-solS Measles-full-length S/solS Preclinical IFNAR-/-mice Paul Ehrlich Institute 78 GreMERSfi Ad5-full-length S/S1 Preclinical BALB/c Mice Greffex, U.S.A. 101 MVA-MERS-S Full-length S Preclinical hDPP4-mice, planning for phase I German Center for Infection Research (DIFZ) 80 Live attenuated rMERS-CoV-ΔE Recombinant MERS-CoV without E In vitro — Universidad Autonoma de Madrid, Spain 90 Open in a separate window MERS-CoV vaccines under development.
Article Title: Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial
Article Snippet: The Research Monitor will provide an unbiased written report of all unanticipated problems involving risks to participants or others, and related SAEs and deaths, within 10 working days to the WRAIR IRB by email (Usarmy.detrick.medcom-wrair.mbx.hspb@mail.mil), or by mail at the following address: Walter Reed Army Institute of Research, ATTN: Human Subjects Protection Branch, 503 Robert Grant Ave, Silver Spring, MD 20910.
Article Title: Harnessing Recent Advances in Synthetic DNA and Electroporation Technologies for Rapid Vaccine Development Against COVID-19 and Other Emerging Infectious Diseases
Article Snippet: MERS , GLS-5300 , MERS S protein , Phase I , NCT02670187 , IM-EP , GeneOne Life Science; Inovio Pharmaceuticals , Yes , 94 and 50% subjects developed binding and neutralizing antibody responses by the third vaccination , 76% Subjects developed T-cell responses by the third vaccination , ( ) .
Article Title: Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial
Article Snippet: GLS-5300 GeneOne Life Science, Inc. Clinical Protocol Date:13Nov2017 v10.0 -36-
Article Title: Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial
Article Snippet: U.S. BB-IND 16711 Version 10.0 GLS-5300 GeneOne Life Science, Inc. WRAIR 2274, HRPO Log A#19272 Clinical Protocol V10.0 -- Date: 13Nov2017 PHASE I, OPEN-LABEL, DOSE RANGING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF GLS-5300, ADMINISTERED IM FOLLOWED BY ELECTROPORATION IN HEALTHY VOLUNTEERS Drug: GLS-5300 Protocol Number: WRAIR #2274 Sponsor: GeneOne Life Science, Inc. 1040 DeKalb Pike, Suite 200 Blue Bell, PA 19422 Principal Investigator Kayvon Modjarrad, MD, PhD Sponsor Medical Monitor: Joel Maslow, MD PhD MBA FACP Institutional Review Boards WRAIR Institutional Review Board (IRB) Walter Reed Army Institute of Research 503 Robert Grant Avenue Silver Spring, Maryland 20910-7500 Telephone: 301-319-9940 / Fax: 301-319-9961 Email: usarmy.detrick.medcom-wrair.list.humansubjects-protection@mail.mil FWA#: 00000015; IRB#: 00000794 Version and Date: Version 10.0 13Nov2017 CONFIDENTIAL The information in this document is considered privileged and confidential by GeneOne Life Science, Inc. and may not be disclosed to others except to the extent necessary to obtain Institutional Review Board/Ethics committee approval and informed consent, or as required by local regulatory authorities.
Article Title: Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial
Article Snippet: GLS-5300 GeneOne Life Science, Inc. Clinical Protocol Date:13Nov2017 v10.0 -33-
Article Title: Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial
Article Snippet: GLS-5300 GeneOne Life Science, Inc. Clinical Protocol Date:13Nov2017 v10.0 -44-
Control:Article Title: Potential Rapid Diagnostics, Vaccine and Therapeutics for 2019 Novel Coronavirus (2019-nCoV): A Systematic Review
Article Snippet: 4 , GeneOne Life Science and Inovio Pharmaceuticals; GLS-5300 , United States (Maryland) Phase I clinical trial; Open-label, single-arm, dose-escalation study; 3 doses of 0·67 mg, 2 mg, or 6 mg GLS-5300; intramuscular 1 mL injection followed immediately by co-localised intramuscular electroporation with CELLECTRA ® -5P device at week 0, 4 and 12 with follow-up through to 48 weeks after dose 3 , 75 healthy adults between 18 and 50 years old (mean age 32.2 years), with normal screening electrocardiogram, screening laboratory findings within normal limits or be grade 0–1 findings, and have no history of clinically significant immunosuppressive or autoimmune disease, HIV, hepatitis B or C virus infection; 25 subjects were randomised into each dose group and 65 subjects completed the study, and per protocol analysis was used. , No vaccine-associated serious adverse events. 97% participants reported at least one solicited adverse event, but most solicited symptoms were reported as mild and were self-limiting (19 [76%] with 0·67 mg, 20 [80%] with 2 mg, and 17 [68%] with 6 mg); injection site reactions were the most common adverse event [92%]. , Seroconversion measured by S1-ELISA occurred in 86% and 94% participants after 2 and 3 doses, respectively, and was maintained in 79% participants up to study end at week 60. Neutralising antibodies were detected in 50% participants at one or more time points during the study, but only 3% maintained neutralisation activity to end of study. T-cell responses were detected in 71% and 76% participants after 2 and 3 doses, respectively. There were no differences in immune responses between dose groups after 6 weeks and vaccine-induced humoral and cellular responses were respectively detected in 77% and 64% participants at week 60. , [ ] .
Article Title: Development of Middle East Respiratory Syndrome Coronavirus vaccines – advances and challenges
Article Snippet: Vaccine candidates under development are listed in and include: DNA vaccines, protein subunit and peptide vaccines, vector-based vaccines, and live attenuated vaccines. table ft1 table-wrap mode="anchored" t5 Table 1. caption a7 Vaccine platform Vaccine name Viral antigen/Product design Status Animal models Institution Ref. DNA GLS-5300 Full-length S Phase I C57BL/6 mice, camels, rhesus GeneOne Life Science, South Korea 53 Protein subunit S-RBD-Fc S1-RBD fused with human Fc Preclinical BALB/c mice, rabbits, hDPP4-mice New York Blood Center, U.S.A., Fudan University, China 47,69 MERS-CoV rRBD Truncated S1-RBD Preclinical BALB/c mice China CDC 59 rNTD rNTD Preclinical BALB/c mice China CDC 70 MERS-S Nanoparticles Preclinical BALB/c mice Novavax, U.S.A. 74,75 Heterologous prime-boost S-DNA/S1 Protein Full-length S (prime) + S1 subunit (boost) Preclinical BALB/c mice, Rhesus U.S. National Institute of Health 55 Vector ChAdOx1-MERS-S Full-length S Preclinical Mice Jenner Institute, UK 84,99 Ad5-S, Ad41-S Full-length S Preclinical Mice China CDC 79 BNSP333-S1 RABV-S1 Preclinical hDPP4-mice Thomas Jefferson Univ., Univ. of Maryland, NIH, U.S.A. 100 MERS-S/MERS-solS Measles-full-length S/solS Preclinical IFNAR-/-mice Paul Ehrlich Institute 78 GreMERSfi Ad5-full-length S/S1 Preclinical BALB/c Mice Greffex, U.S.A. 101 MVA-MERS-S Full-length S Preclinical hDPP4-mice, planning for phase I German Center for Infection Research (DIFZ) 80 Live attenuated rMERS-CoV-ΔE Recombinant MERS-CoV without E In vitro — Universidad Autonoma de Madrid, Spain 90 Open in a separate window MERS-CoV vaccines under development.
Article Title: Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial
Article Snippet: The Research Monitor will provide an unbiased written report of all unanticipated problems involving risks to participants or others, and related SAEs and deaths, within 10 working days to the WRAIR IRB by email (Usarmy.detrick.medcom-wrair.mbx.hspb@mail.mil), or by mail at the following address: Walter Reed Army Institute of Research, ATTN: Human Subjects Protection Branch, 503 Robert Grant Ave, Silver Spring, MD 20910.
Article Title: Harnessing Recent Advances in Synthetic DNA and Electroporation Technologies for Rapid Vaccine Development Against COVID-19 and Other Emerging Infectious Diseases
Article Snippet: MERS , GLS-5300 , MERS S protein , Phase I , NCT02670187 , IM-EP , GeneOne Life Science; Inovio Pharmaceuticals , Yes , 94 and 50% subjects developed binding and neutralizing antibody responses by the third vaccination , 76% Subjects developed T-cell responses by the third vaccination , ( ) .
Article Title: Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial
Article Snippet: GLS-5300 GeneOne Life Science, Inc. Clinical Protocol Date:13Nov2017 v10.0 -36-
Article Title: Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial
Article Snippet: U.S. BB-IND 16711 Version 10.0 GLS-5300 GeneOne Life Science, Inc. WRAIR 2274, HRPO Log A#19272 Clinical Protocol V10.0 -- Date: 13Nov2017 PHASE I, OPEN-LABEL, DOSE RANGING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF GLS-5300, ADMINISTERED IM FOLLOWED BY ELECTROPORATION IN HEALTHY VOLUNTEERS Drug: GLS-5300 Protocol Number: WRAIR #2274 Sponsor: GeneOne Life Science, Inc. 1040 DeKalb Pike, Suite 200 Blue Bell, PA 19422 Principal Investigator Kayvon Modjarrad, MD, PhD Sponsor Medical Monitor: Joel Maslow, MD PhD MBA FACP Institutional Review Boards WRAIR Institutional Review Board (IRB) Walter Reed Army Institute of Research 503 Robert Grant Avenue Silver Spring, Maryland 20910-7500 Telephone: 301-319-9940 / Fax: 301-319-9961 Email: usarmy.detrick.medcom-wrair.list.humansubjects-protection@mail.mil FWA#: 00000015; IRB#: 00000794 Version and Date: Version 10.0 13Nov2017 CONFIDENTIAL The information in this document is considered privileged and confidential by GeneOne Life Science, Inc. and may not be disclosed to others except to the extent necessary to obtain Institutional Review Board/Ethics committee approval and informed consent, or as required by local regulatory authorities.
Article Title: Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial
Article Snippet: GLS-5300 GeneOne Life Science, Inc. Clinical Protocol Date:13Nov2017 v10.0 -33-
Article Title: Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial
Article Snippet: GLS-5300 GeneOne Life Science, Inc. Clinical Protocol Date:13Nov2017 v10.0 -44-
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