Clinical Trial

Trial to Evaluate Immunogenicity Non-Inferiority, Safety and Lot-to-Lot Consistency of Biovac OCV-S to Euvichol®-Plus

Recruiting Phase 3
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Summary
This Phase I/III clinical trial is intended to establish the immunogenicity and safety profile of Biovac OCV-S compared to available WHO pre-qualified vaccine Euvichol®-Plus in healthy adults and children and in adult people living with HIV (PLWH). The lot-to-lot consistency of Biovac OCV-S in healthy adults will also be determined.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-12-11.
Trial Details
NCT Number NCT07304284
Lead Sponsor International Vaccine Institute
Collaborators: BioVac, Medical Research Council, South Africa
Conditions Cholera Vaccination
Enrollment 2,824 participants
Start Date 2025-10-31
Primary Completion 2026-12 (estimated)
Study Completion 2027-02 (estimated)
Updated on ClinicalTrials.gov 2026-01-12