NCT03089879

A Study to Evaluate Safety and Immunogenicity of 1 Booster Dose of 1790GAHB Vaccine in Healthy Adults Primed With 3 Doses of 1790GAHB Vaccine in Study H03_01TP Compared to 1 Vaccination of 1790GAHB in Either Subjects Who Received Placebo in the Same Study or naïve Subjects Not Part of H03_01TP Study

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 22 Years – 50 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Dysentery, Bacillary

Interventions

Type	Name	Description
BIOLOGICAL	GVGH Shigella sonnei 1790GAHB vaccine	Single dose administered at Day 1, by intramuscular injection.

Timeline

• Start date: 2017-03-16
• Primary completion: 2017-08-31
• Completion: 2017-08-31
• First posted: 2017-03-24
• Last updated: 2019-06-28
• Results posted: 2019-03-07

Locations

1 site across 1 country: France