Phase IIII Study of Biovac OCV-S Oral Cholera Vaccine Compared to Euvichol-Plus in South Africans Aged 1 to 45 Years Evaluating Immune Response, Safety, and Consistency Across Vaccine Batches

What this Trial Is About

Researchers are evaluating the immune response and safety of a new cholera vaccine called Biovac OCV-S compared to an existing WHO pre-qualified vaccine, Euvichol4-Plus. This Phase IIII trial is conducted among healthy adults, children, and adults living with HIV in South Africa to determine if Biovac OCV-S is not inferior in producing immune protection. The study also checks the consistency between different lots of Biovac OCV-S in healthy adults aged 18 to 45 years. Participants are divided into four groups based on age and HIV status healthy adults 18-45 years, adults with HIV 18-45 years, healthy children 6-17 years, and healthy children 1-5 years. Adults without HIV are randomized to receive one of three lots of Biovac OCV-S or Euvichol4-Plus, while the other groups receive either Biovac OCV-S or Euvichol4-Plus in different ratios. Each participant receives two oral doses of their assigned vaccine two weeks apart. During the approximately 27-week study, participants are monitored for safety and immune response at specific times after vaccination. The main measurements include the production of antibodies against Vibrio cholerae O1 strains two weeks after the second dose, and any adverse events occurring within 14 days after each vaccine dose. Additional evaluations include antibody levels by age group and lot consistency in adults to assess vaccine performance.

Trial to Evaluate Immunogenicity Non-Inferiority, Safety and Lot-to-Lot Consistency of Biovac OCV-S to Euvichol®-Plus