Actively Recruiting
Trial to Evaluate Immunogenicity Non-Inferiority, Safety and Lot-to-Lot Consistency of Biovac OCV-S to Euvichol®-Plus
Led by International Vaccine Institute · Updated on 2026-01-12
2824
Participants Needed
5
Research Sites
65 weeks
Total Duration
On this page
Sponsors
I
International Vaccine Institute
Lead Sponsor
B
BioVac
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Trial to Evaluate Immunogenicity Non-Inferiority, Safety and Lot-to-Lot Consistency of Biovac OCV-S to Euvichol®-Plus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy participants aged 1 to 45 years at consent
- Participants or their guardians willing to provide informed consent or assent
- HIV negative for healthy cohorts
- Not pregnant or lactating
- For people living with HIV (PLWH): adults aged 18 to 45 years
- PLWH on anti-retroviral therapy with CD4 counts above 350 and undetectable viral loads
- Not pregnant or lactating for PLWH cohort
You will not qualify if you...
- Known allergy to vaccine components or other vaccines
- Major congenital abnormalities
- Known immune function disorders, including HIV in healthy cohorts
- Use of systemic steroids over 10 mg/day prednisone equivalent for longer than 2 weeks in past 6 months
- Receipt of chemotherapy, radiation, or immunosuppressive drugs within past 6 months
- Behavioral, cognitive impairment, chronic substance abuse, psychiatric or neurological disorders
- Known bleeding disorders
- Receipt of blood, blood products, or immunoglobulin in past 3 months
- Receipt of other vaccines within 4 weeks before or after study vaccine doses
- Active or previous Vibrio cholerae infection
- Receipt of cholera vaccine in past 5 years
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Synergy Biomed Research Institute
Durban, Eastern Cape, South Africa, 5201
Not Yet Recruiting
2
Perinatal HIV Research Unit (PHRU)
Johannesburg, Gauteng, South Africa, 1862
Actively Recruiting
3
Wits Vaccines & Infectious Diseases Analytics (VIDA) Research Unit
Johannesburg, Gauteng, South Africa, 1862
Not Yet Recruiting
4
SAMRC Chatworth CRS
Durban, KwaZulu-Natal, South Africa, 4092
Actively Recruiting
5
SAMRC Isipingo CRS
Durban, KwaZulu-Natal, South Africa, 4110
Not Yet Recruiting
Research Team
D
Dr. Naveena D'Cor Project Technical Lead / Study Medical Monitor, MD
CONTACT
B
Beverley Cowper Medical Consultant, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
10
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