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GVGH Shigella sonnei 1790GAHB vaccine · 1 trial · 1 indication
IgG concentrations are expressed as Geometric Mean Concentrations (GMCs), as determined by the Enzyme-linked immunosorbent assay (ELISA) with Shigella sonnei (S.sonnei) O-antigen containing Lipopolysaccharide (LPS) coating antigen. Concentrations are presented as GMCs expressed in ELISA units per milliliter (EU/mL).
| Arm | Type | Description |
|---|---|---|
| Shigella Group | EXPERIMENTAL | Healthy male and female subjects, aged 22 to 50 years, previously primed with 3 doses of the GVGH Shigella sonnei 1790GAHB vaccine in the H03\_01TP parent study and who had undetectable antibody titers at baseline, received one intramuscular booster dose of the same vaccine in the current study, at Day 1. |
| Placebo Group | EXPERIMENTAL | Healthy male and female subjects, aged 22 to 50 years, who previously received placebo in the H03\_01TP parent study and who had undetectable antibodies at baseline, received one intramuscular GVGH Shigella sonnei 1790GAHB vaccine dose in the current study, at Day 1. |
| Naïve Group | EXPERIMENTAL | Healthy male and female subjects, aged 22 to 50 years, who were not part of H03\_01TP parent study, received one intramuscular GVGH Shigella sonnei 1790GAHB vaccine dose in the current study, at Day 1. |
| Name | Type | Description |
|---|---|---|
| GVGH Shigella sonnei 1790GAHB vaccine | BIOLOGICAL | Single dose administered at Day 1, by intramuscular injection. |
Inclusion Criteria: * Males and females, aged 22 to 50 years, who were previously vaccinated, with either vaccine (3 doses) or placebo, in H03\_01TP and who had undetectable antibody titers at baseline, or Males and females, aged 22 to 50 years, who were not part of H03\_01TP. * Individuals who, af...
GVGH Shigella sonnei 1790GAHB vaccine is an investigational vaccine being studied for the prevention of bacillary dysentery, a diarrheal disease caused by Shigella sonnei bacteria. It is currently in Phase 1 clinical development for this infectious disease indication.
GVGH Shigella sonnei 1790GAHB vaccine is being developed by GSK plc, a biopharmaceutical company listed on the stock exchange under the ticker symbol GSK.
GVGH Shigella sonnei 1790GAHB vaccine is in Phase 1 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. One Phase 1 trial has been completed.
GVGH Shigella sonnei 1790GAHB vaccine has one completed clinical trial, NCT03089879. This Phase 1 study evaluated the safety and immunogenicity of a booster dose in healthy adults previously primed with the vaccine, compared to vaccination in placebo recipients or naive subjects. The trial enrolled 35 participants in France.
No, GVGH Shigella sonnei 1790GAHB vaccine is classified as a vaccine, not a monoclonal antibody. It is designed to elicit an immune response against Shigella sonnei, the bacterium that causes bacillary dysentery.