CompletedNot Applicable

A Baseline Study in Support of Clinical Evaluation of an Oral Shigella Vaccine Development in Africa

Burkina Faso, Zambia1,334 participantsStarted 2020-09-14

Plain-language summary

This study aims to address the paucity of accurate incidence data of diarrheal diseases associated with Shigella in Zambia and Burkina Faso. Given the limited feasibility of the current complex diagnostic methods used to detect Shigella in endemic and developing countries due to the costs, the none availability of reagents and a requirement of expensive and complex machinery, we suggest to use a rapide, easy-to-use, cost-effective, and robust Polymerase Chain Reaction (PCR) based rapid tool, the Loop-mediated isothermal amplification (LAMP) based diagnostic assay (ES-RLDT). This baseline study will enable us to generate an accurate estimate of Shigella incidence so as to inform future trials' designs of an oral vaccine development (ShigOraVax) in Burkina Faso and Zambia. This project is part of the EDCTP2 programme supported by the European Union under grant agreement "No RIA2018V-2308

Who can participate

Age range5 Years

SexALL

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Inclusion Criteria: * Children who are under five years, are resident in the catchment areas of participating health facilities and whose parents or guardians have no anticipated plan to leave the area for the next 12 months; * Willing to submit child biological samples for testing and/or storage; * Parent or guardian providing written informed consenting to the study. Exclusion Criteria: * Any child born after the Census has taken place(Zambia) or whose household was not randomly selected from the database (Burkina Faso) * Current participation in a research with the use of any drug or vaccine. * Parent or guardian unwilling to provide consent * Any confirmed or suspected immunosuppressive or immuniodeficiency condition based on medical history and physical examination (No testing will be done for HIV) * A family history of congenital or hereditary immunodeficiency * Major congenital defects * Immunosuppresive therapy within 3 months prior to recruitment

What they're measuring

Incidence of Shigella diarrheal disease in children under fives in Zambia and Burkina Faso

Timeframe: 1 year

Trial details

NCT IDNCT04312906

SponsorCentre for Infectious Disease Research in Zambia

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2021-11-30