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

NCT07304284 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2824

Last updated 2026-01-12

No results posted yet for this study

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.

Conditions

  • Cholera Vaccination

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.

Sponsors & Collaborators

  • BioVac

    collaborator UNKNOWN

  • Medical Research Council, South Africa

    collaborator OTHER

  • International Vaccine Institute

    lead OTHER

Principal Investigators

  • Tarun Saluja, MD · International Vaccine Institute

  • Glenda Gray, MD · Medical Research Council, South Africa

  • Julia Lynch, MD · International Vaccine Institute

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-10-31
Primary Completion
2026-12-31
Completion
2027-02-28

Countries

  • South Africa

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07304284 on ClinicalTrials.gov