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Tests treatment safety and results for Cholera Vaccination
Official title Trial to Evaluate Immunogenicity Non-Inferiority, Safety and Lot-to-Lot Consistency of Biovac OCV-S to Euvichol®-Plus
ClinicalTrials.gov ID: NCT07304284
What this study is testing
What is Experimental: Biovac OCV-S (inactivated whole-cell monovalent (O1) oral cholera vaccine)?
Experimental: Biovac OCV-S (inactivated whole-cell monovalent (O1) oral cholera vaccine) is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for cholera vaccination.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Time commitment: about 27 weeks
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 45. Healthy volunteers may be eligible.
You may be able to join if
- (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 (for PLWH (HIV-positive) cohort AA)
You likely can't join 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...
- Use of systemic steroids within past 6 months (\>10 mg/day prednisone equivalent for periods exceeding 2 consecutive weeks), or receive chemotherapy...
- Behavioral or cognitive impairment, chronic substance abuse, or psychiatric disease or neurological disorders.
- Individuals with a known bleeding disorder.
See the full eligibility 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 (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
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Durban, Eastern Cape, South Africa
- Johannesburg, Gauteng, South Africa
- Durban, KwaZulu-Natal, South Africa
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 27 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 1 year to 45 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Durban, Eastern Cape, South Africa; Johannesburg, Gauteng, South Africa; Durban, KwaZulu-Natal, South Africa. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.