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

NCT07304284 | Recruiting Phase 3 DMC

• 1 other identifier: IVI BIOVAC OCV-S 001
• Study Type: interventional
• Target: 2,824
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Cholera Vaccination

Keywords

Biovac OCV-S; Euvichol®-Plus; IVI BIOVAC OCV-S 001; International Vaccine Institute (IVI); Biovac Institute; South African Medical Research Council (SAMRC)

Outcome Measures

Primary Outcomes (2)

• 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.

  2 weeks after second dose of either Biovac OCV-S (i.e., one lot of Biovac OCV-S) or Euvichol®-Plus

• 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

  Within 14 days after each vaccination

Secondary Outcomes (4)

• Geometric Mean Titer (GMT) of vibriocidal antibodies against Vibrio cholerae O1 Inaba and Ogawa for all ages

  2 weeks after second dose of either Biovac OCV-S (i.e., one lot of Biovac OCV-S) or Euvichol®-Plus

• 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

• GMT of vibriocidal antibodies against Vibrio cholerae O1 Inaba and Ogawa in each age stratum

  2 weeks after second dose of either Biovac OCV-S (i.e., one lot of Biovac OCV-S) or Euvichol®-Plus

• GMT of vibriocidal antibodies against Vibrio cholerae O1 Inaba and Ogawa in adults

  2 weeks after second dose of 3 lots of Biovac OCV-S

Other Outcomes (4)

• 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

• Seroconversion rate and GMT of vibriocidal antibodies

  2 weeks after first dose of either Biovac OCV-S or Euvichol®-Plus

• Seroconversion rate and GMT of vibriocidal antibodies

  2 weeks after one and two doses of Biovac OCV-S and Euvichol®-Plus

Study Arms (10)

Arm A1: Biovac OCV-S

EXPERIMENTAL

Biovac OCV-S (Lot 1), HIV Negative Group, 18-45 years

Biological: Experimental: Biovac OCV-S (inactivated whole-cell monovalent (O1) oral cholera vaccine)

Arm A2: Biovac OCV-S

EXPERIMENTAL

Biovac OCV-S (Lot 2), HIV Negative Group, 18-45 years

Biological: Experimental: Biovac OCV-S (inactivated whole-cell monovalent (O1) oral cholera vaccine)

Arm A3: Biovac OCV-S

EXPERIMENTAL

Biovac OCV-S (Lot 3), HIV Negative Group, 18-45 years

Biological: Experimental: Biovac OCV-S (inactivated whole-cell monovalent (O1) oral cholera vaccine)

Arm A4: Euvichol®-Plus

ACTIVE COMPARATOR

Euvichol®-Plus, HIV Negative Group, 18-45 years

Biological: Active Comparator, Euvichol®-Plus

Arm B1: Biovac OCV-S

EXPERIMENTAL

Biovac OCV-S, HIV Negative Group, 6-17 years

Biological: Experimental: Biovac OCV-S (inactivated whole-cell monovalent (O1) oral cholera vaccine)

Arm B2: Euvichol®-Plus

ACTIVE COMPARATOR

Euvichol®-Plus, HIV Negative Group, 6-17 years

Biological: Active Comparator, Euvichol®-Plus

Arm C1: Biovac OCV-S

EXPERIMENTAL

Biovac OCV-S, HIV Negative Group, 1-5 years

Biological: Experimental: Biovac OCV-S (inactivated whole-cell monovalent (O1) oral cholera vaccine)

Arm C2: Euvichol®-Plus

ACTIVE COMPARATOR

Euvichol®-Plus, HIV Negative Group, 1-5 years

Biological: Active Comparator, Euvichol®-Plus

Arm AA1: Biovac OCV-S

EXPERIMENTAL

Biovac OCV-S, People living with HIV, 18-45 years

Biological: Experimental: Biovac OCV-S (inactivated whole-cell monovalent (O1) oral cholera vaccine)

Arm AA2: Euvichol®-Plus

ACTIVE COMPARATOR

Euvichol®-Plus, People living with HIV, 18-45 years

Biological: Active Comparator, Euvichol®-Plus

Interventions

Active Comparator, Euvichol®-Plus BIOLOGICAL

Two doses (1.5mL) at two weeks interval given orally.

Arm A4: Euvichol®-Plus; Arm AA2: Euvichol®-Plus; Arm B2: Euvichol®-Plus; Arm C2: Euvichol®-Plus

Experimental: Biovac OCV-S (inactivated whole-cell monovalent (O1) oral cholera vaccine) BIOLOGICAL

Two doses (1.5mL) at two weeks interval given orally.

Arm A1: Biovac OCV-S; Arm A2: Biovac OCV-S; Arm A3: Biovac OCV-S; Arm AA1: Biovac OCV-S; Arm B1: Biovac OCV-S; Arm C1: Biovac OCV-S

Eligibility Criteria

• Age: 1 Year - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• International Vaccine Institute: lead
• BioVac: collaborator
• Medical Research Council, South Africa: collaborator

Study Sites (5)

Synergy Biomed Research Institute

Durban, Eastern Cape, 5201, South Africa

NOT YET RECRUITING

Perinatal HIV Research Unit (PHRU)

Johannesburg, Gauteng, 1862, South Africa

RECRUITING

Wits Vaccines & Infectious Diseases Analytics (VIDA) Research Unit

Johannesburg, Gauteng, 1862, South Africa

NOT YET RECRUITING

SAMRC Chatworth CRS

Durban, KwaZulu-Natal, 4092, South Africa

RECRUITING

SAMRC Isipingo CRS

Durban, KwaZulu-Natal, 4110, South Africa

NOT YET RECRUITING

MeSH Terms

Interventions

Cholera Vaccines

Intervention Hierarchy (Ancestors)

Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Tarun Saluja, MD

  International Vaccine Institute

  PRINCIPAL INVESTIGATOR

• Glenda Gray, MD

  Medical Research Council, South Africa

  PRINCIPAL INVESTIGATOR

• Julia Lynch, MD

  International Vaccine Institute

  STUDY DIRECTOR

Central Study Contacts

Dr. Naveena D'Cor Project Technical Lead / Study Medical Monitor, MD

CONTACT

+82 2 8811 000; naveena.dcor@ivi.int

Beverley Cowper Medical Consultant, MD

CONTACT

BeverleyC@biovac.co.za

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2025
• First Posted: December 26, 2025
• Study Start: October 31, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (5)