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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
12
Comparison between sand fly bites from two different species (Phlebotomus papatasi and Phlebotomus duboscqi)
Translational Research Facility, Department of Biology, University of York
York, North Yorkshire, United Kingdom
Percentage of participants who successfully undergo sand fly bite during a 30 minute exposure determined by visual dermatoscopy
Development of a sand fly biting protocol using pathogen-free sand flies which is effective and safe for volunteers: Volunteers aged between 18-65 years will receive a bite or bites by sand flies using a watch-like biting chamber placed on the arm. The investigators will initially evaluate the use of biting chambers containing up to 5 sand flies maintained on the arm for 30 minutes, and evaluate the two sand fly species Phlebotomus papatasi and Phlebotomus duboscqi fed on blood twice in the laboratory prior to human exposure.
Time frame: 21 days
Percentage of participants with visual changes following sand fly bite using photography.
The investigators will use photography to identify and record skin changes following sand fly bite by use of photography.
Time frame: 21 days
Percentage of participants with visual changes following sand fly bite using dermatoscopy.
The investigators will use dermatoscopy to identify and record skin changes following sand fly bite.
Time frame: 21 days
Percentage of participants with demonstrable serological evidence of sand fly bite. To determine human immunological response to sand fly bite using serology and cellular response measurement.
The investigators will measure serology including Leishmania and sand fly salivary gland antibodies following sand fly bite.
Time frame: 21 days
Percentage of participants with demonstrable cellular response evidence of sand fly bite.
The investigators will measure cellular response following sand fly bite
Time frame: 21 days
Percentage of participants with demonstrable evidence of change in IgE (immunoglobulin E) following sand fly bite.
The investigators will measure IgE at baseline and following sand fly bite
Time frame: 21 days
Percentage of participants with significant change in C-reactive protein following sand fly bite.
C-Reactive protein will be measured at baseline and following sand fly bite/
Time frame: 21 days
Determine size of lesion following sand fly bite over time
Rulers will be used to determine the changing size of any lesion
Time frame: 21 days
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