A Clinical Study to Develop an Uninfected Sand Fly Biting Protocol
Condition: Leishmaniasis, Cutaneous; Insect Bites
MeSH terms: Leishmaniasis; Leishmaniasis, Cutaneous; Insect Bites and Stings
Study type: Interventional

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.
    

Detailed 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.
    

Intervention name(s): Sand fly bite
Intervention type(s): Other
Intervention description(s): Comparison between sand fly bites from two different species (Phlebotomus papatasi and Phlebotomus duboscqi)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Clinical study
Masking: None (Open Label)
Primary purpose: Other
Keywords: Cutaneous Leishmaniasis; Controlled Human Infection Model; Sand Fly; Human Challenge