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Category: Project

Description: Leishmaniasis is a globally important disease for which we currently have no vaccines for human use. In this project (https://leishchallenge.org), we aim to develop a "human challenge infection model" (CHIM) for leishmaniasis that will serve to accelerate the development of vaccines and allow selection of appropriate candidates to enter large scale clinical trials. A human challenge model involves volunteers being experimentally infected with a microbe and then following the development of disease until a suitable end point. These models are being used to test vaccines for malaria, dengue fever and other diseases. To establish a human challenge model of leishmaniasis, we will first conduct focus group discussions with members of the public to ascertain attitudes to this type of research and inform how we design the studies. As leishmaniasis is transmitted by sand flies, we will then evaluate the best way to allow sand flies to bite humans in a controlled manner (the FLYBITE study; clinical trials.gov NCT03999970). Similar studies are often performed with mosquitoes. We have also developed a well-characterised stock of parasites for use now and in the future (Ashwin et al. Nat. Commun. 2021. 12:215; https://doi.org/10.1038/s41467-020-20569-3). Finally, we will conduct a human challenge study to establish parameters for future clinical trials of leishmaniasis candidate vaccines (LEISH_CHALLENGE; clinical trials.gov NCT04512742). The projects is jointly funded by the UK Medical Research Council (MRC) and the UK Department for International Development (DFID) under the MRC/DFID Concordat agreement and is also part of the EDCTP2 programme supported by the European Union.