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
International Vaccine Institute
2,824 participants
Oct 31, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria7
- Healthy participants aged 1 to 45 years at consent
- Participants/Parent(s)/Legally Authorized Representative (LAR) willing to provide informed consent/assent
- HIV negative
- Not pregnant or lactating
- PLWH adults aged 18 to 45 years at consent
- Participants on anti-retroviral (ARV) therapy with CD4 counts \>350 and viral loads that are undetectable.
- Not pregnant or lactating
Exclusion Criteria10
- Known history or allergy to investigational vaccine components, other preventive vaccines, or any other allergies
- Individuals with major congenital abnormalities
- Known history of immune function disorders including immunodeficiency diseases (known HIV infection in healthy participant cohorts) or other immune function disorders (all cohorts).
- 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.
- Behavioral or cognitive impairment, chronic substance abuse, or psychiatric disease or neurological disorders.
- Individuals with a known bleeding disorder.
- Receipt of blood, blood-derived products, or immunoglobulin products in the past 3 months.
- Individuals who have received other vaccines from 4 weeks prior to or within 4 weeks after any dose of the investigational product.
- Individuals with active or previous Vibrio cholerae infection.
- Individuals with receipt of a cholera vaccine in the past 5 years.
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Interventions
Two doses (1.5mL) at two weeks interval given orally.
Two doses (1.5mL) at two weeks interval given orally.
Locations(5)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07304284