Safety and reactogenicity of a controlled human infection model of sand fly-transmitted cutaneous leishmaniasis.

ABSTRACT: The leishmaniases are globally important parasitic diseases for which no human vaccines are currently available. To facilitate vaccine development, we conducted an open-label observational study to establish a controlled human infection model (CHIM) of sand fly-transmitted cutaneous leishmaniasis (CL) caused by Leishmania major. Between 24 January and 12 August 2022, we exposed 14 participants to L. major-infected Phlebotomus duboscqi. The primary objective was to demonstrate effectiveness of lesion development (take rate) and safety (absence of CL lesion at 12 months). Secondary and exploratory objectives included rate of lesion development, parasite load and analysis of local immune responses by immunohistology and spatial transcriptomics. Lesion development was terminated by therapeutic

SUBMITTER: Parkash V 

PROVIDER: S-EPMC11564116 | biostudies-literature | 2024 Nov

REPOSITORIES: biostudies-literature