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RECRUITING
NCT07304284
PHASE3

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

Sponsor: International Vaccine Institute

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

Experimental: Biovac OCV-S (inactivated whole-cell monovalent (O1) oral cholera vaccine)

Two doses (1.5mL) at two weeks interval given orally.

BIOLOGICAL

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