A Clinical Study to Develop an Uninfected Sand Fly Biting Protocol
Research type
Research Study
Full title
A clinical study to develop a sand fly biting protocol using pathogen-free blood-fed sand flies
IRAS ID
266151
Contact name
Charles Lacey
Contact email
Sponsor organisation
University of York
Clinicaltrials.gov Identifier
applied for, ClinicalTrials.gov
Duration of Study in the UK
0 years, 11 months, 31 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 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.
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 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 we can assess any future vaccines against Leishmaniasis.
We will also hold a focus group after the sand fly biting study to explore the experiences of individuals taking part in this study.REC name
South Central - Hampshire A Research Ethics Committee
REC reference
19/SC/0297
Date of REC Opinion
2 Aug 2019
REC opinion
Further Information Favourable Opinion