Trial to Evaluate Immunogenicity Non-Inferiority, Safety and Lot-to-Lot Consistency of Biovac OCV… (NCT07304284) | Clinical Trial Compass
RecruitingPhase 3
Trial to Evaluate Immunogenicity Non-Inferiority, Safety and Lot-to-Lot Consistency of Biovac OCV-S to Euvichol®-Plus
South Africa2,824 participantsStarted 2025-10-31
Plain-language 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.
Who can participate
Age range1 Year – 45 Years
SexALL
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Inclusion criteria
âś“. Healthy participants aged 1 to 45 years at consent
âś“. Participants/Parent(s)/Legally Authorized Representative (LAR) willing to provide informed consent/assent
âś“. HIV negative
âś“. Not pregnant or lactating
âś“. PLWH adults aged 18 to 45 years at consent
âś“. Participants on anti-retroviral (ARV) therapy with CD4 counts \>350 and viral loads that are undetectable.
âś“. Not pregnant or lactating
Exclusion criteria
âś•. Known history or allergy to investigational vaccine components, other preventive vaccines, or any other allergies
âś•. Individuals with major congenital abnormalities
âś•. Known history of immune function disorders including immunodeficiency diseases (known HIV infection in healthy participant cohorts) or other immune function disorders (all cohorts).
âś•. 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.
âś•. Behavioral or cognitive impairment, chronic substance abuse, or psychiatric disease or neurological disorders.
What they're measuring
1
Seroconversion of vibriocidal titers against Vibrio cholerae O1 Inaba and O1 Ogawa
Timeframe: 2 weeks after second dose of either Biovac OCV-S (i.e., one lot of Biovac OCV-S) or Euvichol®-Plus
2
Incidence of Treatment-Emergent Adverse Events in the HIV negative group
Timeframe: Within 14 days after each vaccination
Trial details
NCT IDNCT07304284
SponsorInternational Vaccine Institute
Sponsor typeOTHER
Study typeINTERVENTIONAL
Primary completion2026-12
Contact for this trial
Dr. Naveena D'Cor Project Technical Lead / Study Medical Monitor, MD