Compare Biovac OCV-S and Euvichol‑Plus for immunogenicity, safety, and lot consistency
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
This research will test whether the oral vaccine Biovac OCV‑S works as well and is as safe as Euvichol‑Plus for children, healthy adults, and adults living with HIV.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 2824 (estimated) |
| Ages | 1 Year to 45 Years |
| Sex | All |
| Sponsor | International Vaccine Institute Academic / other |
| Drugs / interventions | chemotherapy, radiation, prednisone |
| Locations | 5 sites (Durban, Eastern Cape and 4 other locations) |
| Trial ID | NCT07304284 on ClinicalTrials.gov |
What this trial studies
This is a phase I/III, multicenter, observer‑blinded, age‑descending, randomized, active‑controlled trial conducted at sites in South Africa to compare Biovac OCV‑S with the WHO‑prequalified Euvichol‑Plus. A total of 2,824 participants aged 1–45 years are enrolled across four cohorts: healthy adults, adults living with HIV, children 6–17 years, and children 1–5 years, with cohort A adults also randomized across three manufacturing lots to test lot‑to‑lot consistency. Participants receive two oral doses two weeks apart and are followed for safety and antibody responses at prespecified time points over about 27 weeks. The primary focus is non‑inferiority of immunogenicity and evaluation of safety profiles between the vaccines.
Who should consider this trial
Good fit: Ideal candidates are people aged 1–45 who are not pregnant or lactating, willing to consent, including healthy children and adults and adults living with HIV who are on antiretroviral therapy with CD4 >350 and undetectable viral load.
Not a fit: People outside the 1–45 age range, pregnant or lactating individuals, those with known immune disorders or severe allergies to vaccine components, and people with uncontrolled or untreated HIV are unlikely to benefit from participating.
Why it matters
Potential benefit: If successful, Biovac OCV‑S could become an additional WHO‑acceptable oral cholera vaccine that offers similar protection and helps increase vaccine supply for outbreak control and prevention.
How similar studies have performed: Killed whole‑cell oral cholera vaccines like Euvichol‑Plus have demonstrated good immunogenicity and safety in prior studies, so this vaccine approach is well established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Inclusion Criteria (for healthy/HIV-negative cohorts A, B and C) 1. Healthy participants aged 1 to 45 years at consent 2. Participants/Parent(s)/Legally Authorized Representative (LAR) willing to provide informed consent/assent 3. HIV negative 4. Not pregnant or lactating Inclusion Criteria (for PLWH (HIV-positive) cohort AA) 1. PLWH adults aged 18 to 45 years at consent 2. Participants on anti-retroviral (ARV) therapy with CD4 counts \>350 and viral loads that are undetectable. 3. Not pregnant or lactating Exclusion Criteria: 1. Known history or allergy to investigational vaccine components, other preventive vaccines, or any other allergies 2. Individuals with major congenital abnormalities 3. Known history of immune function disorders including immunodeficiency diseases (known HIV infection in healthy participant cohorts) or other immune function disorders (all cohorts). 4. Use of systemic steroids within past 6 months (\>10 mg/day prednisone equivalent for periods exceeding 2 consecutive weeks), or receive chemotherapy, radiation therapy or other immunosuppressive drugs within the past 6 months. 5. Behavioral or cognitive impairment, chronic substance abuse, or psychiatric disease or neurological disorders. 6. Individuals with a known bleeding disorder. 7. Receipt of blood, blood-derived products, or immunoglobulin products in the past 3 months. 8. Individuals who have received other vaccines from 4 weeks prior to or within 4 weeks after any dose of the investigational product. 9. Individuals with active or previous Vibrio cholerae infection. 10. Individuals with receipt of a cholera vaccine in the past 5 years.
Where this trial is running
Durban, Eastern Cape and 4 other locations
- Synergy Biomed Research Institute — Durban, Eastern Cape, South Africa (Not_yet_recruiting)
- Perinatal HIV Research Unit (PHRU) — Johannesburg, Gauteng, South Africa (Recruiting)
- Wits Vaccines & Infectious Diseases Analytics (VIDA) Research Unit — Johannesburg, Gauteng, South Africa (Not_yet_recruiting)
- SAMRC Chatworth CRS — Durban, KwaZulu-Natal, South Africa (Recruiting)
- SAMRC Isipingo CRS — Durban, KwaZulu-Natal, South Africa (Not_yet_recruiting)
Study contacts
- Principal investigator: Tarun Saluja, MD — International Vaccine Institute
- Study coordinator: Dr. Naveena D'Cor Project Technical Lead / Study Medical Monitor, MD
- Email: naveena.dcor@ivi.int
- Phone: +82 2 8811 000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.