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New cholera vaccine trial aims to protect south africans of all ages

NCT ID NCT07304284

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new oral cholera vaccine (Biovac OCV-S) to see if it works as well as a currently approved vaccine (Euvichol-Plus). About 2,824 healthy people aged 1 to 45, including some adults living with HIV, will receive two doses. Researchers will check immune responses and monitor for side effects over several months.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 2,824 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

1 year to 45 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Inclusion Criteria (for healthy/HIV-negative cohorts A, B and C) 1. Healthy participants aged 1 to 45 years at consent 2. Participants/Parent(s)/Legally Authorized Representative (LAR) willing to provide informed consent/assent 3. HIV negative 4. Not pregnant or lactating Inclusion Criteria (for PLWH (HIV-positive) cohort AA) 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: 1. Known history or allergy to investigational vaccine components, other preventive vaccines, or any other allergies 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    5 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Perinatal HIV Research Unit (PHRU)

    RECRUITING

    Johannesburg, Gauteng, 1862, South Africa

  • SAMRC Chatworth CRS

    RECRUITING

    Durban, KwaZulu-Natal, 4092, South Africa

  • SAMRC Isipingo CRS

    NOT_YET_RECRUITING

    Durban, KwaZulu-Natal, 4110, South Africa

  • Synergy Biomed Research Institute

    NOT_YET_RECRUITING

    Durban, Eastern Cape, 5201, South Africa

  • Wits Vaccines & Infectious Diseases Analytics (VIDA) Research Unit

    NOT_YET_RECRUITING

    Johannesburg, Gauteng, 1862, South Africa

More trials for these conditions

Other studies related to the condition(s) this trial covers.