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.
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
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.
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Treatment groupsSee each treatment group below.
International Vaccine Institute
Lead sponsor
BioVac
Collaborator
Medical Research Council, South Africa
Collaborator