Compare Biovac OCV-S and Euvichol‑Plus for immunogenicity, safety, and lot consistency
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
Run by International Vaccine Institute · NCT07304284 · Data updated 2026-11-12
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 |
| Ages | 1 Year to 45 Years |
| Sex | All |
| Enrollment | 2824 (estimated) |
| Sponsor | International Vaccine Institute Academic / other |
| Drugs / interventions | chemotherapy, radiation, prednisone |
| Locations | 5 sites (Durban, Eastern Cape and 4 other locations) |
| Status | Recruiting |
| Started | October 31, 2025 |
| Main results expected | December 2026 |
| Study ends | February 2027 |
| Registry record updated | January 12, 2026 |
| Trial ID | NCT07304284 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
Perinatal HIV Research Unit (PHRU)
Johannesburg, Gauteng, South Africa Recruiting -
SAMRC Chatworth CRS
Durban, KwaZulu-Natal, South Africa Recruiting -
Synergy Biomed Research Institute
Durban, Eastern Cape, South Africa Not yet recruiting -
Wits Vaccines & Infectious Diseases Analytics (VIDA) Research Unit
Johannesburg, Gauteng, South Africa Not yet 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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Age-descending safety and immune response of a cholera conjugate vaccine in people aged 1–45
This trial will test whether one or two doses of a 25 μg cholera conjugate vaccine, with or without an aluminum adjuvant, are safe and produce immune responses in people aged 1 to 45 living in a cholera-endemic area.
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Extended dosing schedules for the oral cholera vaccine in Kenya
This tests whether giving the Euvichol-S oral cholera vaccine with longer gaps between doses (2 months or 12 months instead of the standard 2 weeks) produces a similar immune response in people aged 1 year and older in Mukuru, Nairobi.
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PanChol vaccine safety study in healthy adults
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Understanding immune responses to typhoid and cholera vaccines
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.