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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 developed by GSK plc for bacillary dysentery, an infectious disease caused by Shigella sonnei bacteria. It is a preventive vaccine candidate designed to protect against this form of dysentery and has been studied in healthy adult volunteers.
GVGH Shigella sonnei 1790GAHB vaccine is being developed for the prevention of bacillary dysentery, an infectious disease associated with Shigella sonnei. The vaccine candidate targets this condition in healthy adult volunteers and falls within the infectious disease therapeutic area.
GSK plc, which trades under the ticker GSK, is the developer of the GVGH Shigella sonnei 1790GAHB vaccine. The vaccine candidate is part of GSK's infectious disease pipeline and targets bacillary dysentery.
GVGH Shigella sonnei 1790GAHB vaccine is in Phase 1 clinical development. It is an investigational vaccine candidate and has not been approved for commercial use. The Phase 1 program has been completed, with one trial conducted in France.
GVGH Shigella sonnei 1790GAHB vaccine has been evaluated in one completed Phase 1 trial, NCT03089879. This study assessed the safety and immunogenicity of a booster dose of the 1790GAHB vaccine in healthy adults who had been primed with three prior doses, compared with a single vaccination in other subjects. The trial enrolled 35 participants in France.
GVGH Shigella sonnei 1790GAHB vaccine is not approved; it is an investigational vaccine candidate in Phase 1 clinical development. Its only recorded trial, NCT03089879, has been completed. The vaccine targets bacillary dysentery and was studied in healthy adult volunteers.