Understanding the epidemiology of iNTS disease in Africa in preparation for future iNTS

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Date
2020-10-08
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Kamuzu University of Health Sciences
Abstract
Type of study Clinical research study involving collecting samples from human participants. Prospective serological studies will be carried out across 4 sub-Saharan African sites (Malawi, Kenya, Burkina Faso, Ghana), for which Malawi will be the leading site. A core protocol has been written for all 4 sites in a separate document. This protocol focuses on the Malawi site. Methods to measure age-stratified acquisition of antibody and bactericidal activity to NTS. Data will be collected on the key risk factors for invasive disease: malaria, anaemia and malnutrition and stool samples to measure enteric NTS exposure. Children 0 to 5 years selected from mapped and censused randomly selected households Chikwawa, Malawi; an area with substantial malaria burden - a key risk factor for iNTS. Paired immunology and stool samples for NTS taken 3 months apart for 2000 children; distributed over each age stratum of 1 year, from the age of 0 to 5 years (4000 samples in total). A small number of confirmed invasive NTS cases identified at Queen Elizabeth Hospital (QECH), Blantyre, Malawi, will also have samples for investigated for antibody and bactericidal activity at presentation and 1 month follow-up. Other sites (Kenya, Burkina Faso, Ghana): Prospective serological community study with unpaired/ single samples taken from children aged 0-5 years. No data collected on risk factors. Expected findings and dissemination We will describe the pattern of immunological susceptibility to NTS and enteric exposure in relation to risk factors and geographical settings to facilitate early iNTS vaccine licensure. The final study report will be submitted to the College of Medicine Research Ethics Committee (COMREC) University of Malawi, University of Liverpool IRB and the funders (Wellcome Trust and VacciNTS project). The results will be presented locally, nationally and internationally including other partner sites in the seroepidemiology work package of the VacciNTS consortium contributing to key knowledge for vaccine development and deployment. This will have relevance for policy decisions regarding iNTS control in Malawi and other sub-Saharan African countries. Results will be submitted for publication in a peer reviewed academic journal.
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Research Subject Categories::MEDICINE
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