RecruitingPhase 3NCT07304284

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

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

Sponsor

International Vaccine Institute

Enrollment

2,824 participants

Start Date

Oct 31, 2025

Study Type

INTERVENTIONAL

Conditions

Cholera Vaccination

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.

Eligibility

Min Age: 1 YearMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called Active Comparator, Euvichol®-Plus and a biological treatment called Experimental: Biovac OCV-S (inactivated whole-cell monovalent (O1) oral cholera vaccine) for people with cholera vaccination. The study is currently recruiting participants at 5 locations. People eligible for this study include aged 1 Year to 45 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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

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

BIOLOGICALActive 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

View Full Details on ClinicalTrials.gov

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NCT07304284

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