LEISH_Challenge
Research type
Research Study
Full title
A clinical study to develop a controlled human infection model using Leishmania major-infected sand flies
IRAS ID
286420
Contact name
Charles Lacey
Contact email
Sponsor organisation
University of York
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 6 months, days
Research summary
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 sand fly is visible but small and inconspicuous.
There are different types of leishmaniasis which can 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.
We do have some treatments for leishmaniasis but many of them are not easy to use or don’t work well. Therefore, we need new treatments and would like to find vaccines that prevent or work against leishmaniasis.
A solution being adopted for other diseases, which we 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 knowledge that has led to advances in the development of treatments.
This is study builds on an our initial successful study, FLYBITE, where we used uninfected (disease-free) sand flies to test the safety aspects and ensure that sand flies were able to bite human participants in a controlled environment. We observed no major adverse effects and it was well tolerated by participants. We therefore wish to proceed to a study using sand flies infected with a form of leishmaniasis that causes localised skin disease and is treatable, on the pathway to assessing future vaccines.REC name
South Central - Hampshire A Research Ethics Committee
REC reference
20/SC/0348
Date of REC Opinion
8 Dec 2020
REC opinion
Further Information Favourable Opinion