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Updated: Jun 23, 2026
Cutaneous Leishmaniasis in the Dorsal Skin of Hamsters: a Useful Model for the Screening of Antileishmanial Drugs
Published on: April 21, 2012
Assessing public perception of a sand fly biting study on the pathway to a controlled human infection model for
Vivak Parkash1,2, Georgina Jones3, Nina Martin3
1York Biomedical Research Institute, Hull York Medical School, University of York, York, UK. vivak.parkash@york.ac.uk.
Background:
A controlled human infection model (CHIM) involves deliberate exposure of volunteers to pathogens to assess their response to new therapies at an early stage of development. We show here how we used public involvement to help shape the design of a CHIM to support future testing of candidate vaccines for the neglected tropical disease cutaneous leishmaniasis, a disease transmitted by the bite of infected sand flies in tropical regions.
Methods:
We undertook a public involvement (PI) consultation exercise to inform development of a study to test the safety and effectiveness of a sand fly biting protocol using uninfected sand flies (FLYBITE: ClinicalTrials.gov ID NCT03999970 ) and a CHIM using Leishmania major-infected sand flies (LEISH_Challenge: ClinicalTrials.gov ID NCT04512742 ), both taking place in York, UK. We involved 10 members of the public including a patient research ambassador and a previous CHIM volunteer. The session took place at The University of York, UK and examined draft study volunteer-facing material and included the CHIM study design, potential adverse events and therapeutic interventions at study endpoints. A discussion of the scientific, ethical, humanitarian and economic basis for the project was presented to the participants to provoke discourse. An inductive, thematic analysis was used to identify the participants' key concerns.
Results:
Themes were identified relating to i) quality of volunteer-facing written information, ii) improving study design, and iii) factors to motivate involvement in the research. Group participants responded positively to the overall study aims. Initial concerns were expressed about potential risks of study involvement, but further explanation of the science and mitigations of risk secured participant support. Participants provided advice and identified improved terminology to inform the volunteer-facing material. Lastly, treatment options were discussed, and excision of any cutaneous lesion was favoured over alternatives as a treatment.
Conclusion:
The consultation exercise provided invaluable information which led to improved study design and enhanced clarity in the volunteer-facing material. The session also reinforced the need to maintain public trust in scientific rigour prior to initiation of any study. The investigators hope that this description strengthens understanding of PI in clinical research, and encourages its use within other studies.
Insights
Public involvement enhanced the design of a controlled human infection model (CHIM) for cutaneous leishmaniasis vaccine development. Consultation improved volunteer information and study design, ensuring public trust in early-stage clinical research.
Area of Science:
- Tropical medicine
- Infectious disease research
- Clinical trial design
Background:
- Controlled human infection models (CHIM) are crucial for early-stage drug and vaccine development.
- Cutaneous leishmaniasis is a neglected tropical disease transmitted by sand flies.
Purpose of the Study:
- To integrate public involvement (PI) into the design of a CHIM for cutaneous leishmaniasis.
- To refine study protocols and volunteer-facing materials for a CHIM using infected sand flies.
Main Methods:
- A public involvement consultation exercise was conducted with 10 members of the public.
- Participants reviewed draft volunteer-facing materials, study design, and potential risks/interventions.
- Thematic analysis was used to identify key concerns and recommendations.
Main Results:
- Public feedback led to improvements in volunteer-facing information and study design.
- Participants expressed initial concerns about risks, which were mitigated by clear explanations.
- Excision of cutaneous lesions was favored as a treatment option.
Conclusions:
- Public involvement significantly enhanced the design and clarity of the CHIM protocols.
- Consultation reinforced the importance of public trust and scientific rigor.
- The study advocates for wider adoption of public involvement in clinical research.
