Medicine and Health

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

V. Parkash, H. Ashwin, et al.

In an innovative leap for leishmaniasis vaccine development, researchers conducted a controlled human infection model of cutaneous leishmaniasis, revealing a 64% lesion take rate and insights into immune responses. Conducted by esteemed authors, this study also showcased effective management of lesions and no severe adverse events, paving the way for future vaccine advancements.

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Abstract

To facilitate leishmaniasis vaccine development, an open-label observational study established a controlled human infection model (CHIM) of sand fly-transmitted cutaneous leishmaniasis (CL) using *Leishmania major*. 14 participants were exposed to infected *Phlebotomus duboscqi*. The primary objective was to demonstrate effectiveness (lesion development) and safety. Secondary objectives included lesion development rate, parasite load, and immune response analysis. A 64% take rate was observed. Lesions were treated by therapeutic biopsy. Two participants experienced recurrences, successfully treated with cryotherapy. No severe adverse events occurred; scarring was observed. The CHIM provides opportunities for vaccine candidate selection and understanding of immune-mediated pathology.

Publisher

Nature Medicine

Published On

Nov 01, 2024

Authors

Vivak Parkash, Helen Ashwin, Shoumit Dey, Jovana Sadlova, Barbora Vojtkova, Katrien Van Bocxlaer, Rebecca Wiggins, David Thompson, Nidhi Sharma Dey, Charles L. Jaffe, Eli Schwartz, Petr Volf, Charles J. N. Lacey, Alison M. Layton, Paul M. Kaye

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