CompletedPhase 2

Human Challenge With Live-attenuated Rotavirus to Assess Next-generation Rotavirus Vaccines in Africa

Zambia720 participantsStarted 2021-04-15

Plain-language summary

Despite the widespread introduction of vaccines against Rotavirus, Rotavirus continues to be a cause of significant morbidity and mortality in the developing world. This study will assess protection against rotavirus infection and investigate immune correlates of protection following vaccination with a novel trivalent VP8 subunit rotavirus vaccine used alone or in combination with oral rotavirus vaccine.

Who can participate

Age range

6 Weeks – 10 Weeks

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Healthy infants as established by medical history and physical examination. * Infants will be 6-10 weeks old at time of enrollment * parents plan to remain in the area for the duration of the study. * Parent/guardian understands the study procedures and willing to provide informed consent to participate in the study Exclusion Criteria: * Acutely unwell * Infant or infant's mother has syndromic or documented evidence of being immunocompromised (independent of HIV status) * Known allergy to any vaccine component * Previously received rotavirus vaccine * Received immunosuppressive medication * Major congenital or genetic abnormality * Any condition in the parents/infant that, in the judgment of the investigator, would interfere with or serves as a contraindication to protocol adherence or a participant's parents' ability to give informed consent. * Participant's parents not available or willing to accept active follow-up by the study staff

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Vaccine Shedding

Timeframe: 5-9 days after Challenge

Trial details

NCT IDNCT04658914

SponsorCentre for Infectious Disease Research in Zambia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-08-30

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