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

RecruitingPhase 3Ages 1 Year - 45 YearsAllInternational Vaccine Institute
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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.
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What it tests

  • Experimental: Biovac OCV-S (inactivated whole-cell monovalent (O1) oral cholera vaccine)
  • Active Comparator, Euvichol®-Plus
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Where

5 sites
Synergy Biomed Research Institute
Durban, South Africa
Perinatal HIV Research Unit (PHRU)
Johannesburg, South Africa
Wits Vaccines & Infectious Diseases Analytics (VIDA) Research Unit
Johannesburg, South Africa
SAMRC Chatworth CRS
Durban, South Africa
SAMRC Isipingo CRS
Durban, South Africa
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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