Dysentery, Bacillary Clinical Trial
Official title:
A Phase 1, Open Label, Non-randomized, Single Center Study to Evaluate the Safety and Immunogenicity of 1 Booster Vaccination With (GVGH Shigella Sonnei 1790GAHB) Vaccine Administered Intramuscularly in Healthy Adults Previously Primed With Three Doses of the Same Vaccine in Study H03_01TP Compared to 1 Vaccination With (1790GAHB) Administered Intramuscularly Either to Subjects Who Received Placebo in the H03_01TP Study or naïve Subjects Who Were Not Part of H03_01TP Study
GVGH Shigella Sonnei 1970GAHB is a vaccine aimed at preventing the disease caused by Shigella
sonnei.
A post-hoc analysis of subjects who participated in the parent study showed significantly
different responses in subjects with detectable versus undetectable antibody titres at
baseline, suggesting the possibility that the vaccine might not be sufficiently immunogenic
in completely naïve adults.
This study was then designed to further characterize the immunogenicity profile of the
vaccine and to evaluate whether it was able to induce an immunological memory response.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03561181 -
Safety Study of S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine in Healthy Volunteers Aged Above 3 Months
|
Phase 1 | |
| Completed |
NCT04865497 -
Immunogenicity and Safety of S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine in Volunteers Aged From 3 Months to 5 Years Old
|
Phase 2 | |
| Completed |
NCT03527173 -
A Study to Evaluate the Efficacy, Safety and Immunogenicity of a Vaccine Designed to Protect Against Infection With Shigella Sonnei in Healthy Adults
|
Phase 2 |