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Trial to Evaluate Immunogenicity Non-Inferiority, Safety and Lot-to-Lot Consistency of Biovac OCV-S to Euvichol®-Plus
Sponsor: International Vaccine Institute
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.
Official title: Phase I/III, Multicenter, Observer-Blinded, Randomized, Active Controlled Trial to Evaluate Immunogenicity Non-Inferiority, Safety and Lot-to-Lot Consistency of Biovac OCV-S to Euvichol®-Plus in 1 to 45 Years Old South Africans
Key Details
Gender
All
Age Range
1 Year - 45 Years
Study Type
INTERVENTIONAL
Enrollment
2824
Start Date
2025-10-31
Completion Date
2027-02
Last Updated
2026-01-12
Healthy Volunteers
Yes
Conditions
Interventions
Experimental: Biovac OCV-S (inactivated whole-cell monovalent (O1) oral cholera vaccine)
Two doses (1.5mL) at two weeks interval given orally.
Active Comparator, Euvichol®-Plus
Two doses (1.5mL) at two weeks interval given orally.
Locations (5)
Synergy Biomed Research Institute
Durban, Eastern Cape, South Africa
Perinatal HIV Research Unit (PHRU)
Johannesburg, Gauteng, South Africa
Wits Vaccines & Infectious Diseases Analytics (VIDA) Research Unit
Johannesburg, Gauteng, South Africa
SAMRC Chatworth CRS
Durban, KwaZulu-Natal, South Africa
SAMRC Isipingo CRS
Durban, KwaZulu-Natal, South Africa