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
Status: Recruiting
Location: See all (5) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 1
Maximum Age: 45
Healthy Volunteers: t
View:
• 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
Locations
Other Locations
South Africa
SAMRC Chatworth CRS
RECRUITING
Durban
SAMRC Isipingo CRS
NOT_YET_RECRUITING
Durban
Synergy Biomed Research Institute
NOT_YET_RECRUITING
Durban
Perinatal HIV Research Unit (PHRU)
RECRUITING
Johannesburg
Wits Vaccines & Infectious Diseases Analytics (VIDA) Research Unit
NOT_YET_RECRUITING
Johannesburg
Contact Information
Primary
Dr. Naveena D'Cor Project Technical Lead / Study Medical Monitor, MD
naveena.dcor@ivi.int
+82 2 8811 000
Backup
Beverley Cowper Medical Consultant, MD
BeverleyC@biovac.co.za
Time Frame
Start Date: 2025-10-31
Estimated Completion Date: 2027-02
Participants
Target number of participants: 2824
Treatments
Experimental: Arm A1: Biovac OCV-S
Biovac OCV-S (Lot 1), HIV Negative Group, 18-45 years
Experimental: Arm A2: Biovac OCV-S
Biovac OCV-S (Lot 2), HIV Negative Group, 18-45 years
Experimental: Arm A3: Biovac OCV-S
Biovac OCV-S (Lot 3), HIV Negative Group, 18-45 years
Active_comparator: Arm A4: Euvichol®-Plus
Euvichol®-Plus, HIV Negative Group, 18-45 years
Experimental: Arm B1: Biovac OCV-S
Biovac OCV-S, HIV Negative Group, 6-17 years
Active_comparator: Arm B2: Euvichol®-Plus
Euvichol®-Plus, HIV Negative Group, 6-17 years
Experimental: Arm C1: Biovac OCV-S
Biovac OCV-S, HIV Negative Group, 1-5 years
Active_comparator: Arm C2: Euvichol®-Plus
Euvichol®-Plus, HIV Negative Group, 1-5 years
Experimental: Arm AA1: Biovac OCV-S
Biovac OCV-S, People living with HIV, 18-45 years
Active_comparator: Arm AA2: Euvichol®-Plus
Euvichol®-Plus, People living with HIV, 18-45 years
Sponsors
Leads: International Vaccine Institute
Collaborators: BioVac, Medical Research Council, South Africa