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How Gut Health Affects Immune Responses to the Oral Rotavirus Vaccine in Adults in Zambia

Recruitingn/aAges 18 Years - 50 YearsAllCentre for Infectious Disease Research in Zambia
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In plain words

What the trial is, and whether it could suit you

The Rotavirus SpatioTrasncriptomics (Rota-Omics) study is a multidisciplinary research project aimed at understanding why oral rotavirus vaccines perform less effectively in some low- and middle-income countries, including Zambia. Rotavirus remains one of the leading causes of severe diarrheal disease in infants and young children worldwide, despite the widespread introduction of vaccines such as Rotarix® and Rotavac®. Although these vaccines have greatly reduced childhood deaths in many countries, vaccine effectiveness is often lower in settings where the burden of disease is highest. Understanding the reasons behind this reduced protection is critical for improving child health globally. A major focus of the study is Environmental Enteropathy (EE), also known as Environmental Enteric Dysfunction (EED), a chronic inflammatory condition of the small intestine that is common in low-resou

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📋 Eligibility rules (as published)
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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What it tests

  • Rotarix®,
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Where

1 site
TROPGAN
Lusaka, Zambia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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