Trial to Evaluate Immunogenicity Non-Inferiority, Safety and Lot-to-Lot Consistency of Biovac OCV-S to Euvichol®-Plus
NCT ID: NCT07304284
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
2824 participants
INTERVENTIONAL
2025-10-31
2027-02-28
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Arm A1
Biovac-OCV (Lot 1), HIV Negative Group, 18-45 years
Experimental: Biovac OCV-S (inactivated whole-cell monovalent (O1) oral cholera vaccine)
Two doses (1.5mL) at two weeks interval given orally.
Arm A2
Biovac-OCV (Lot 2), HIV Negative Group, 18-45 years
Experimental: Biovac OCV-S (inactivated whole-cell monovalent (O1) oral cholera vaccine)
Two doses (1.5mL) at two weeks interval given orally.
Arm A3
Biovac-OCV (Lot 3), HIV Negative Group, 18-45 years
Experimental: Biovac OCV-S (inactivated whole-cell monovalent (O1) oral cholera vaccine)
Two doses (1.5mL) at two weeks interval given orally.
Arm A4
Euvichol®-Plus, HIV Negative Group, 18-45 years
Active Comparator, Euvichol®-Plus
Two doses (1.5mL) at two weeks interval given orally.
Arm B1
Biovac-OCV, HIV Negative Group, 6-17 years
Experimental: Biovac OCV-S (inactivated whole-cell monovalent (O1) oral cholera vaccine)
Two doses (1.5mL) at two weeks interval given orally.
Arm B2
Euvichol®-Plus, HIV Negative Group, 6-17 years
Active Comparator, Euvichol®-Plus
Two doses (1.5mL) at two weeks interval given orally.
Arm C1
Biovac-OCV, HIV Negative Group, 1-5 years
Experimental: Biovac OCV-S (inactivated whole-cell monovalent (O1) oral cholera vaccine)
Two doses (1.5mL) at two weeks interval given orally.
Arm C2
Euvichol®-Plus, HIV Negative Group, 1-5 years
Active Comparator, Euvichol®-Plus
Two doses (1.5mL) at two weeks interval given orally.
Arm AA1
Biovac-OCV, People living with HIV, 18-45 years
Experimental: Biovac OCV-S (inactivated whole-cell monovalent (O1) oral cholera vaccine)
Two doses (1.5mL) at two weeks interval given orally.
Arm AA2
Euvichol®-Plus, People living with HIV, 18-45 years
Active Comparator, Euvichol®-Plus
Two doses (1.5mL) at two weeks interval given orally.
Interventions
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Experimental: Biovac OCV-S (inactivated whole-cell monovalent (O1) oral cholera vaccine)
Two doses (1.5mL) at two weeks interval given orally.
Active Comparator, Euvichol®-Plus
Two doses (1.5mL) at two weeks interval given orally.
Eligibility Criteria
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Inclusion Criteria
2. Participants/Parent(s)/Legally Authorized Representative (LAR) willing to provide informed consent/assent
3. HIV negative
4. Not pregnant or lactating
1. PLWH adults aged 18 to 45 years at consent
2. Participants on anti-retroviral (ARV) therapy with CD4 counts \>350 and viral loads that are undetectable.
3. Not pregnant or lactating
Exclusion Criteria
2. Individuals with major congenital abnormalities
3. Known history of immune function disorders including immunodeficiency diseases (known HIV infection in healthy participant cohorts) or other immune function disorders (all cohorts).
4. 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.
5. Behavioral or cognitive impairment, chronic substance abuse, or psychiatric disease or neurological disorders.
6. Individuals with a known bleeding disorder.
7. Receipt of blood, blood-derived products, or immunoglobulin products in the past 3 months.
8. Individuals who have received other vaccines from 4 weeks prior to or within 4 weeks after any dose of the investigational product.
9. Individuals with active or previous Vibrio cholerae infection.
10. Individuals with receipt of a cholera vaccine in the past 5 years.
1 Year
45 Years
ALL
Yes
Sponsors
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BioVac
UNKNOWN
Medical Research Council, South Africa
OTHER
International Vaccine Institute
OTHER
Responsible Party
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Principal Investigators
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Tarun Saluja, MD
Role: PRINCIPAL_INVESTIGATOR
International Vaccine Institute
Glenda Gray, MD
Role: PRINCIPAL_INVESTIGATOR
Medical Research Council, South Africa
Julia Lynch, MD
Role: STUDY_DIRECTOR
International Vaccine Institute
Locations
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Synergy Biomed Research Institute
Durban, Eastern Cape, South Africa
Perinatal HIV Research Unit (PHRU)
Johannesburg, Gauteng, South Africa
Wits Vaccines & Infectious Diseases Analytics (VIDA) Research Unit
Johannesburg, Gauteng, South Africa
SAMRC Chatworth CRS
Durban, KwaZulu-Natal, South Africa
SAMRC Isipingo CRS
Durban, KwaZulu-Natal, South Africa
Countries
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Central Contacts
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Dr. Naveena D'Cor Project Technical Lead / Study Medical Monitor, MD
Role: CONTACT
Phone: +82 2 8811 000
Email: [email protected]
Facility Contacts
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Mookho Malahleha Principal Investigator
Role: primary
Ravindre Panchia Principal Investigator
Role: primary
Christopher Stavrou Principal Investigator
Role: primary
Logashvari Naidoo Principal Investigator
Role: primary
Vimla Naicker Principal Investigator
Role: primary
Other Identifiers
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IVI BIOVAC OCV-S 001
Identifier Type: -
Identifier Source: org_study_id