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.
Parallel
Experimental: Biovac OCV-S (inactivated whole-cell monovalent (O1) oral cholera vaccine)
Biological/VaccineTwo doses (1.5mL) at two weeks interval given orally.
Active Comparator, Euvichol®-Plus
Biological/VaccineTwo doses (1.5mL) at two weeks interval given orally.
10
Treatment groupsSee each treatment group below.
Seroconversion of vibriocidal titers against Vibrio cholerae O1 Inaba and O1 Ogawa
Proportion of participants showing seroconversion of vibriocidal titers against Vibrio cholerae O1 Inaba and O1 Ogawa (seroconversion is defined as at least 4-fold increase of vibriocidal titers compared to baseline) at 2 weeks after second dose of either Biovac OCV-S (i.e., one lot of Biovac OCV-S) or Euvichol®-Plus for all ages, in the HIV negative group.
Incidence of Treatment-Emergent Adverse Events in the HIV negative group
Safety of each investigational product dose at a specified duration in the HIV negative group: 1. Occurrence of any Serious Adverse Event (SAE)/ Adverse Event of Special Interest (AESI)/ Medically Attended Adverse Event (MAAE) from the first dose vaccination throughout the final study visit 2. Occurrence of immediate adverse events within 30 minutes after each dose vaccination 3. Occurrence of solicited adverse events within 7 days after each dose vaccination 4. Occurrence of unsolicited adverse events within 14 days after each dose vaccination
Geometric Mean Titer (GMT) of vibriocidal antibodies against Vibrio cholerae O1 Inaba and Ogawa for all ages
GMT of vibriocidal antibodies against Vibrio cholerae O1 Inaba and Ogawa 2 weeks after second dose of either Biovac OCV-S (i.e., one lot of Biovac OCV-S) or Euvichol®-Plus for all ages, in the HIV negative group.
Proportion of participants showing seroconversion against Vibrio cholerae O1 Inaba and Ogawa
The proportion of participants showing seroconversion against Vibrio cholerae O1 Inaba and Ogawa 2 weeks after second dose of either Biovac OCV-S (i.e., one lot of Biovac OCV-S) or Euvichol®-Plus in each age stratum, in the HIV negative group.
GMT of vibriocidal antibodies against Vibrio cholerae O1 Inaba and Ogawa in each age stratum
GMT of vibriocidal antibodies against Vibrio cholerae O1 Inaba and Ogawa 2 weeks after second dose of either Biovac OCV-S (i.e., one lot of Biovac OCV-S) or Euvichol®-Plus in each age stratum, in the HIV negative group.
GMT of vibriocidal antibodies against Vibrio cholerae O1 Inaba and Ogawa in adults
GMT of vibriocidal antibodies against Vibrio cholerae O1 Inaba and Ogawa 2 weeks after second dose of 3 lots of Biovac OCV-S in adults in the HIV negative group.
Proportion of participants showing seroconversion of vibriocidal titers against Vibrio cholerae O1 Inaba and Ogawa
The proportion of participants showing seroconversion of vibriocidal titers against Vibrio cholerae O1 Inaba and Ogawa 2 weeks after second dose of 3 lots of Biovac OCV-S in adults in the HIV negative group.
Seroconversion rate and GMT of vibriocidal antibodies
Seroconversion rate and GMT of vibriocidal antibodies 2 weeks after first dose of either Biovac OCV-S or Euvichol®-Plus for all ages and for each age stratum, in the HIV negative group.
Seroconversion rate and GMT of vibriocidal antibodies
Seroconversion rate and GMT of vibriocidal antibodies 2 weeks after one and two doses of Biovac OCV-S and Euvichol®-Plus for adults, in the PLWH group.
Incidence of Treatment-Emergent Adverse Events in the PLWH group
Safety of each investigational product dose at a specified duration in the PLWH group: 1. Occurrence of any SAE/AESI/MAAE from the first dose vaccination throughout the final study visit 2. Occurrence of immediate adverse events within 30 minutes after each dose vaccination 3. Occurrence of solicited adverse events within 7 days after each dose vaccination 4. Occurrence of unsolicited adverse events within 14 days after each dose vaccination
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International Vaccine Institute
Lead sponsor
BioVac
Collaborator
Medical Research Council, South Africa
Collaborator
