Overview
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.
Description
This is a phase I/III, multicenter, observer-blinded, age-descending, randomized, active controlled trial being conducted in South Africa to evaluate the immunogenicity non-inferiority and safety of Biovac OCV-S compared to Euvichol®-Plus among adults and children, and to evaluate the lot-to-lot consistency of Biovac OCV-S in adults.
A total of 2824 participants aged 1-45 years will be enrolled in the study in 4 cohorts: cohort A (1272 healthy adults aged 18-45 years), cohort AA (160 people living with HIV (PLWH) aged 18-45 years), cohort B (696 healthy children aged 6-17 years), and cohort C (696 healthy children aged 1-5 years). Participants in cohort A will be randomized into 4 arms to receive either one of the 3 lots of Biovac OCV-S or to receive the comparator Euvichol®-Plus in 1:1:1:1 ratio. Participants in cohorts AA, B and C will each be randomized into 2 arms to receive either Biovac OCV-S or Euvichol®-Plus in 3:1 ratio.
Each of the study participants will receive the assigned investigational product Biovac OCV-S or Euvichol®-Plus given orally in 2 doses at 2 weeks interval and will be followed up for safety and immunogenicity at specific time points. Each participant will be in the study for approximately 27 weeks.
Eligibility
Inclusion Criteria:
Inclusion Criteria (for healthy/HIV-negative cohorts A, B and C)
- 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
Inclusion Criteria (for PLWH (HIV-positive) cohort AA)
- 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
Exclusion Criteria:
- 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.
- Behavioral or cognitive impairment, chronic substance abuse, or psychiatric disease or neurological disorders.
- Individuals with a known bleeding disorder.
- Receipt of blood, blood-derived products, or immunoglobulin products in the past 3 months.
- Individuals who have received other vaccines from 4 weeks prior to or within 4 weeks after any dose of the investigational product.
- Individuals with active or previous Vibrio cholerae infection.
- Individuals with receipt of a cholera vaccine in the past 5 years.