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Leishmaniasis Leishmaniasis, Cutaneous Insect Bites and Stings
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
The disease leishmaniasis mainly occurs in hot and tropical countries, affects millions of people and causes around 20,000 deaths across the world every year. Leishmaniasis is caused by the Leishmania parasite and is transmitted by sand flies. The parasite is tiny and not visible to the naked eye, whereas the particular sand fly is visible but small and inconspicuous. There are different types of leishmaniasis around the world and some can be very serious. They affect the skin (cutaneous leishmaniasis) or the internal organs of the body (visceral leishmaniasis). Some of the milder forms will produce skin problems which will be localised, whilst other forms of leishmaniasis will cause widespread skin changes. The skin lesions of cutaneous leishmaniasis can be disfiguring if left untreated.
There are some treatments for leishmaniasis available but many of them are not easy to use or don't work well. Therefore new treatments and vaccines are needed that prevent or work against leishmaniasis.
A solution being adopted for other diseases, which the investigators now wish to adopt for leishmaniasis is to develop a 'Controlled human infection model' (CHIM). These models involve deliberate exposure of individuals to an infection, in order to better understand how the disease works and to test potential vaccines and treatments. They have contributed vital scientific knowledge that has led to advances in the development of drugs and vaccines.
This is an initial study using uninfected (disease-free) sand flies, taking place at the University of York. The information from this study will help us to develop a model in the future using infected sand flies so that the investigators can assess any future vaccines against Leishmaniasis. The investigators will also hold a focus group after the sand fly biting study to explore the experiences of individuals taking part in this study.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
"Parkash V, Ashwin H, Sadlova J, Vojtkova B, Jones G, Martin N, Greensted E, Allgar V, Kamhawi S, Valenzuela JG, Layton AM, Jaffe CL, Volf P, Kaye PM, Lacey CJN. A clinical study to optimise a sand fly biting protocol for use in a controlled human infection model of cutaneous leishmaniasis (the FLYBITE study). Wellcome Open Res. 2021 Jun 30;6:168. doi: 10.12688/wellcomeopenres.16870.1. eCollection 2021."; "34693027"; "Parkash V, Jones G, Martin N, Steigmann M, Greensted E, Kaye P, Layton AM, Lacey CJ. Assessing public perception of a sand fly biting study on the pathway to a controlled human infection model for cutaneous leishmaniasis. Res Involv Engagem. 2021 May 30;7(1):33. doi: 10.1186/s40900-021-00277-y."; "34053461"
You can take part if:
You may not be able to take part if:
This is in the inclusion criteria above
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
The study is sponsored by University of York and is in collaboration with Medical Research Council.
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
