Journal: Vaccine: X

Article Title: Vaccine delivery systems and administration routes: Advanced biotechnological techniques to improve the immunization efficacy

doi: 10.1016/j.jvacx.2024.100500

Figure Lengend Snippet: Vaccines using protein subunit in phase 3 and phase 4.

Article Snippet: 22 , PS , Protein subunit , SCTV01C. A Bivalent Recombinant Trimeric S Protein vaccine against SARS-CoV-2 Variants , 1 , Day 0 , IM , Sinocelltech Ltd. , 3.

Techniques: Vaccines, Recombinant, Adjuvant, Variant Assay, Plasmid Preparation, Expressing

Journal: mSphere

Article Title: Vaccination with a Recombinant H7 Hemagglutinin-Based Influenza Virus Vaccine Induces Broadly Reactive Antibodies in Humans

doi: 10.1128/mSphere.00502-17

Figure Lengend Snippet: Human antibody response to vaccination with recombinant H7 HA as measured by HI assay (A and B) and ELISA (C and D). (A) HI titers of enrolled subjects ( n = 382) at time points day 0 (D0), day 21, and day 42 postprime for the four different treatment groups. The dashed line represents an HI titer of 1:40, which was defined as seroconversion (4-fold increase in HI titer or HI titer of ≥1:40). The bars indicate the geometric mean (GM) of all data points. (B) Induction of HI titers over baseline after one vaccination (D21) and two vaccinations (D42). (C) Absolute ELISA AUC values of antibodies binding to matched HA of A/Anhui/1/2013 after vaccination with recombinant H7 HA. (D) Induction for the time points day 21 and day 42 postvaccination for the four different treatment groups. The results are presented as GM values relative to baseline. In panels A and C, time points day 0, day 21, and day 42 were compared to each other within a treatment group in a one-way ANOVA. In panels B and D, each day 21 time point was compared to every day 21 time point of all other treatment groups. The same comparison was performed for the day 42 time point. Significance is indicated as follows: no symbol, P > 0.05; *, P ≤ 0.05; **, P ≤ 0.01; ***, P ≤ 0.001; ****, P ≤ 0.0001. adj., adjuvant.

Article Snippet: The tested human serum samples were obtained during a phase I/II double-blind, adaptive-design clinical trial to evaluate the immunogenicity and safety of Panblok, conducted with Protein Sciences Corporation’s recombinant pandemic H7 HA vaccine (ClinicalTrials.gov identifier NCT02464163).

Techniques: Recombinant, HI Assay, Enzyme-linked Immunosorbent Assay, Binding Assay

Journal: mSphere

Article Title: Vaccination with a Recombinant H7 Hemagglutinin-Based Influenza Virus Vaccine Induces Broadly Reactive Antibodies in Humans

doi: 10.1128/mSphere.00502-17

Figure Lengend Snippet: Cross-reactive antibody response to HAs from emerging Eurasian and American lineage H7 viruses after H7 A/Anhui/1/2013 vaccination as measured by ELISA. (A) Serum samples from a subselection of samples (high-dose 30-µg recombinant HA adjuvanted group) were tested for binding to H7 HAs of different H7NX virus isolates (H7N9 A/Hunan/02285/2017, H7N9 A/Hong Kong/2014/2017, H7N9 A/Guangdong/17SF003/2016, H7N2 A/feline/New York/16-040082-1/2016, and H7N8 A/turkey/Indiana/16-001403-1/2016). Absolute ELISA area under the curve (AUC) values were determined. Data for baseline (D0, white) and postvaccination (D42, red) serum samples are shown. The dashed lines represent the GM titer of serum antibodies binding to A/Anhui/1/2013 at day 0 (gray line) and day 42 (black line) as shown in Fig. 1C . (B) Fold induction of cross-reactive H7 antibodies based on ELISA AUC values postvaccination (D42). The dashed line represents the induction based on the ELISA AUC values of serum antibodies binding to A/Anhui/1/2013 as shown in Fig. 1D . Time points day 0 and day 42 were compared within each treatment group in a one-way ANOVA. Significance is indicated as follows: no symbol, P > 0.05; *, P ≤ 0.05; **, P ≤ 0.01; ***, P ≤ 0.001; ****, P ≤ 0.0001.

Article Snippet: The tested human serum samples were obtained during a phase I/II double-blind, adaptive-design clinical trial to evaluate the immunogenicity and safety of Panblok, conducted with Protein Sciences Corporation’s recombinant pandemic H7 HA vaccine (ClinicalTrials.gov identifier NCT02464163).

Techniques: Enzyme-linked Immunosorbent Assay, Recombinant, Binding Assay

Journal: mSphere

Article Title: Vaccination with a Recombinant H7 Hemagglutinin-Based Influenza Virus Vaccine Induces Broadly Reactive Antibodies in Humans

doi: 10.1128/mSphere.00502-17

Figure Lengend Snippet: Cross-group reactivity. (A) A phylogenetic tree of group 2 HAs is depicted on the left. The scale bar at the bottom shows 5% difference in amino acid identity. Heat map showing the ELISA area under the curve values for H1, H4, H14, H3, H10, H7, and H15 for time points day 0 (D0), day 21 (D21), and day 42 (D42) postvaccination. The color key (AUC values of 0 to 1,000) is shown on the right. For analysis, all treatment groups ( n = 35 per group) were combined. (B) Heat map representing the fold induction based on absolute ELISA values over baseline at time points day 21 (D21) and day 42 (D42) postvaccination for all group 2 HAs and group 1 HA H1 (Cal09). The color key is shown (fold induction of 0 to 24) on the right. The four different treatment groups were combined for analysis ( n = 35 per group). (C) Reciprocal IC 50 values for the five different groups as measured in an H3/stalk mAb competition ELISA are shown for time points day 0, day 21, and day 42. The bars represent the geometric mean values. Time points day 0, day 21, and day 42 were compared to each other within a treatment group in a one-way ANOVA. (D) Induction of reciprocal IC 50 values for day 21 and day 42 serum samples over baseline (day 0). The bars show the GM values. Statistical significance was analyzed for each day 21 time point compared to every other day 21 time point. The same procedure was applied for time point day 42. Significance is indicated as follows: no symbol, P > 0.05; *, P ≤ 0.05; **, P ≤ 0.01; ***, P ≤ 0.001; ****, P ≤ 0.0001. adj., adjuvant.

Article Snippet: The tested human serum samples were obtained during a phase I/II double-blind, adaptive-design clinical trial to evaluate the immunogenicity and safety of Panblok, conducted with Protein Sciences Corporation’s recombinant pandemic H7 HA vaccine (ClinicalTrials.gov identifier NCT02464163).

Techniques: Enzyme-linked Immunosorbent Assay

Journal: mSphere

Article Title: Vaccination with a Recombinant H7 Hemagglutinin-Based Influenza Virus Vaccine Induces Broadly Reactive Antibodies in Humans

doi: 10.1128/mSphere.00502-17

Figure Lengend Snippet: In vitro functionality of human serum antibodies induced by H7 vaccination. (A) ADCC AUC values measured for the four different treatment groups and the HI seroconverter group. The bars show the geometric means of the AUC values. (B) GMs of induction over baseline at day 42 after two vaccinations based on AUC values are represented for the HI seroconverter group (1.9-fold, green hexagons), 7.5-µg-plus-adjuvant group (2.8-fold, purple circles), 15-µg-plus-adjuvant (adj.) group (1.4-fold, yellow triangles), 30-µg-plus-adjuvant group (1.8-fold, blue squares), and 30-µg no-adjuvant group (1.2-fold, red diamonds). The dashed line represents a 1-fold increase in ADCC activity. (C) Individual titers of neutralizing serum antibodies in a microneutralization assay using the H7N9 A/Shanghai/1/2013 strain. The HI seroconverter group (green hexagons), high-dose (30-µg) adjuvanted group (blue squares), and 30-µg nonadjuvanted group (red diamonds) were selected for analysis. The dashed line represents the limit of detection (titer of 1:10), and the bars show the geometric means. (D) Increase in microneutralization (MN) titers over baseline at day 42. The dashed line represents a 1-fold increase in microneutralization titers. In panels A and C, time points day 0 and day 42 within one group were analyzed for significance values in a one-way ANOVA. In panels B and D, each column was compared to every other column. Significance is indicated as follows: no symbol, P > 0.05; *, P ≤ 0.05; **, P ≤ 0.01; ***, P ≤ 0.001; ****, P ≤ 0.0001.

Article Snippet: The tested human serum samples were obtained during a phase I/II double-blind, adaptive-design clinical trial to evaluate the immunogenicity and safety of Panblok, conducted with Protein Sciences Corporation’s recombinant pandemic H7 HA vaccine (ClinicalTrials.gov identifier NCT02464163).

Techniques: In Vitro, Activity Assay, Microneutralization Assay

Journal: mSphere

Article Title: Vaccination with a Recombinant H7 Hemagglutinin-Based Influenza Virus Vaccine Induces Broadly Reactive Antibodies in Humans

doi: 10.1128/mSphere.00502-17

Figure Lengend Snippet: In vivo protectivity of human serum antibodies in a lethal mouse challenge model. (A) Graphic representation of the serum transfer and lethal challenge animal experiment. Sera from all individuals of a selected group were pooled and given to female BALB/c mice ( n = 10 per group). After 2 h, the mice were infected intranasally with 5 50% lethal doses (2 × 10 4 PFU) of H7N9 virus (A/Shanghai/1/13, PR8-based 6:2 reassortant). Weight loss and survival were monitored for 14 days. (B) The weight loss curve of the mouse challenge experiment is shown. The dashed colored lines represent the prevaccination sera. The dashed gray line represents 75% of initial body weight, which was used as the humane endpoint. (C) Survival graph showing percent survival in the different groups used in the animal experiment. The dashed lines represent prevaccination sera. (D) Anti-H7 antibody levels of the groups used in the challenge experiment are shown as ELISA AUC values. The dotted lines at titers of 10, 100, and 1,000 indicate differences of 1 log. Time point day 0 of each group was tested against every other time point day 0 in a one-way ANOVA with a Sidak posttest for multiple comparisons. The same analysis was applied for time point day 42. Significance is indicated as follows: no symbol, P > 0.05; *, P ≤ 0.05; **, P ≤ 0.01; ***, P ≤ 0.001; ****, P ≤ 0.0001. adj., adjuvant.

Article Snippet: The tested human serum samples were obtained during a phase I/II double-blind, adaptive-design clinical trial to evaluate the immunogenicity and safety of Panblok, conducted with Protein Sciences Corporation’s recombinant pandemic H7 HA vaccine (ClinicalTrials.gov identifier NCT02464163).

Techniques: In Vivo, Infection, Enzyme-linked Immunosorbent Assay