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Zambia study aims to unlock secrets of rotavirus vaccine failure

NCT ID NCT07626606

Knowledge-focused Sponsor: Centre for Infectious Disease Research in Zambia Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looks at why oral rotavirus vaccines are less effective in some low-income countries like Zambia. Researchers will collect blood, stool, and tissue samples from 43 adults to study how gut health and the immune system affect vaccine response. The goal is to find biological clues that could help improve vaccines for children worldwide.

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.

Participants

About 43 people

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

Started

Mar 2026

Expected to finish

Dec 2026

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.

Who is studied

Healthy adults living in Chawama, a densely populated peri-urban setting in proximity to the study recruitment site.

Ages

18 to 50 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: * Age ≥ 18 years and ≤ 50 years. * Able and willing to provide written informed consent. * Reside within Lusaka district and available for scheduled follow-up. * Willing to undergo two endoscopy procedures with serial sample collection. Exclusion Criteria: * Pregnant or breastfeeding. * Active gut disease requiring treatment (e.g., active peptic ulcer disease, gastrointestinal bleeding). * Known severe immunodeficiency (HIV with CD4 \< 200 cells/mm³, current cancer chemotherapy, systemic corticosteroids equivalent to \>20 mg/day prednisolone for \>2 weeks). * Severe comorbidities rendering endoscopy unsafe (e.g., severe cardiopulmonary disease, uncontrolled hypertension, oropharyngeal abnormalities). * Use of anticoagulants where suspension is unsafe or unwillingness to withhold anticoagulation when clinically indicated. * Receipt of any live vaccine within 30 days prior to enrolment or planned live vaccine within 30 days after Rotarix administration. * Any condition judged by the investigator to compromise participant safety or data integrity. * Participants who had a recent diarrhoea episode, or who have taken NSAID drugs or antibiotics, will be eligible for re-assessment after a month without this disqualifier. Pregnancy testing and counselling: Women of reproductive potential will require a negative urine pregnancy test within 24 hours prior to endoscopy and vaccination and will be counselled to avoid pregnancy during the first 30 days post-vaccination.

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Conditions

The condition(s) this trial relates to.

Rotavirus infection

As listed by the trial registrant

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

Feasibility study Rota virus gastroenteritis Transcriptomics Vaccine immune response

How to take part

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

  1. The places running it

    1 site. 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

  • TROPGAN

    RECRUITING

    Lusaka, Lusaka Province, P.O.BOX34681LUSAKA,ZAMBIA10101, Zambia

More trials for these conditions

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