NCT07304284

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

Phase I/III, Multicenter, Observer-Blinded, Randomized, Active Controlled Trial to Evaluate Immunogenicity Non-Inferiority, Safety and Lot-to-Lot Consistency of Biovac OCV-S to Euvichol®-Plus in 1 to 45 Years Old South Africans

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,824 (estimated)
• Sponsor: International Vaccine Institute · Academic / Other
• Sex: All
• Age: 1 Year – 45 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Cholera Vaccination

Interventions

Type	Name	Description
BIOLOGICAL	Experimental: Biovac OCV-S (inactivated whole-cell monovalent (O1) oral cholera vaccine)	Two doses (1.5mL) at two weeks interval given orally.
BIOLOGICAL	Active Comparator, Euvichol®-Plus	Two doses (1.5mL) at two weeks interval given orally.

Timeline

• Start date: 2025-10-31
• Primary completion: 2026-12-01
• Completion: 2027-02-01
• First posted: 2025-12-26
• Last updated: 2026-01-12

Locations

5 sites across 1 country: South Africa