A Study to Assess the Safety, Efficacy and Immunogenicity of Leishmania Vaccine ChAd63-KH in PKDL

Summary

This trial is designed to assess the therapeutic efficacy and safety of CHAd63-KH, a new candidate Leishmania vaccine, in patients with persistent PKDL. 100 participants will be randomly assigned (50 participants in each arm) to receive placebo or ChAd63-KH 7.5 x10(10)vp. Doses will be administered at a single time point.

Timeline

Start

2020-04-06

Primary completion

2022-08-31

Completion

2023-02-28

Publications

• Younis BM, Wiggins R, Khalil EAG, Osman M, Santoro F, Sonnati C, Keding A, Novedrati M, Montesi G, Noureldein A, Elmukashfi ETA, Mustafa AE, Alamin M, Saeed M, Salman K, Suliman AJ, Musa AEA, Layton AM, Lacey CJN, Kaye PM, Musa AM. A randomized, double-blind phase 2b trial to evaluate efficacy of ChAd63-KH for treatment of post kala-azar dermal leishmaniasis. Mol Ther Methods Clin Dev. 2024 Jul 30;32(3):101310. doi: 10.1016/j.omtm.2024.101310. eCollection 2024 Sep 12.
• Lacey C, Musa A, Khalil ET, Younis B, Osman M, Wiggins R, Keding A, Kaye P. LEISH2b - A phase 2b study to assess the safety, efficacy, and immunogenicity of the Leishmania vaccine ChAd63-KH in post-kala azar dermal leishmaniasis. Wellcome Open Res. 2022 Aug 3;7:200. doi: 10.12688/wellcomeopenres.17951.1. eCollection 2022.

Drugs

Indications