NCT03999970: FLYBITE

A Clinical Study to Develop an Uninfected Sand Fly Biting Protocol

Completed NA Last updated 31 October 2022

What this trial tests

NA trial testing Sand fly bite in Leishmaniasis, Cutaneous in 12 participants. Completed in 10 January 2020.

Timeline

3 October 2019

Primary endpoint
23 December 2019

10 January 2020

Quick facts

Lead sponsor	University of York
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	12
Start date	3 October 2019
Primary completion	23 December 2019
Estimated completion	10 January 2020
Sites	1 location across United Kingdom

Drugs / interventions tested

• Sand fly bite

Conditions studied

• Leishmaniasis, Cutaneous — all drugs for Leishmaniasis, Cutaneous →
• Insect Bites — all drugs for Insect Bites →

Sponsor

University of York

Who can join

Adults 18 to 65, any sex, with Leishmaniasis, Cutaneous or Insect Bites. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Characterization of a new Leishmania major strain for use in a controlled human infection model.
   Ashwin H, Sadlova J, Vojtkova B, Becvar T, et al · · 2021 · cited 40× · PMID 33431825 · DOI 10.1038/s41467-020-20569-3
2. Assessing public perception of a sand fly biting study on the pathway to a controlled human infection model for cutaneous leishmaniasis.
   Parkash V, Jones G, Martin N, Steigmann M, et al · · 2021 · cited 9× · PMID 34053461 · DOI 10.1186/s40900-021-00277-y
3. A clinical study to optimise a sand fly biting protocol for use in a controlled human infection model of cutaneous leishmaniasis (the FLYBITE study).
   Parkash V, Ashwin H, Sadlova J, Vojtkova B, et al · · 2021 · cited 7× · PMID 34693027 · DOI 10.12688/wellcomeopenres.16870.1
4. Leishmaniasis Vaccines: Applications of RNA Technology and Targeted Clinical Trial Designs.
   Duthie MS, Machado BAS, Badaró R, Kaye PM, et al · · 2022 · cited 6× · PMID 36365010 · DOI 10.3390/pathogens11111259
5. A clinical study to optimise a sand fly biting protocol for use in a controlled human infection model of cutaneous leishmaniasis (the FLYBITE study)
   Parkash V, Ashwin H, Sadlova J, Vojtkova B, et al · · 2021 · DOI 10.12688/wellcomeopenres.16870.1