A Clinical Study to Develop an Uninfected Sand Fly Biting Protocol — FLYBITE  

Leishmaniasis, Cutaneous Clinical Trial

Official title: A Clinical Study to Develop a Sand Fly Biting Protocol Using Pathogen-free Blood-fed Sand Flies

Status Completed

Clinical Trial 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.

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.

Clinical Trial Description

This is a healthy-volunteer clinical study to develop a sand fly biting protocol. 12 participants will be recruited for the study. It is an open-label randomized clinical study with 2 arms (for 2 different species of sand fly: Phlebotomus papatasi and Phlebotomus duboscqi). Participants will be randomized to each arm with 6 participants in each arm. This study will take place at the Translational Research Facility (Q Block), Hull York Medical School & Department of Biology, University of York, York.

The participants will be followed up to 21 days post-sand fly bite. There will then be a focus group once all participants have completed their follow-up. ;

Related Conditions & MeSH terms

• Insect Bites
• Insect Bites and Stings
• Leishmaniasis
• Leishmaniasis, Cutaneous

• NCT number: NCT03999970
• Study type: Interventional
• Source: University of York
• Status: Completed
• Phase: N/A
• Start date: October 3, 2019
• Completion date: January 10, 2020