A Study of a New Leishmania Vaccine Candidate ChAd63-KH

Summary

This is a study to assess the safety of a new candidate Leishmania vaccine ChAd63-KH in patients with persistent post kala azar dermal leishmaniasis (PKDL). This is a Phase II trial in patients with PKDL, to assess the safety and compare the humoral and cellular immune responses generated by the candidate vaccine in patients, and observe any clinical changes in the disease over a 42 day period following vaccination. Study design: Eight adult volunteers will receive 1x10(10)vp and the subsequent eight volunteers will receive 7.5 x10(10)vp. Adolescents will be vaccinated with either 1x10(10)vp or 7.5 x10(10)vp, to be determined by evaluation of all available data after DSMB \& CTSC review.

Timeline

Start

2016-11

Primary completion

2019-09-30

Completion

2019-12-31

Publications

• Younis BM, Osman M, Khalil EAG, Santoro F, Furini S, Wiggins R, Keding A, Carraro M, Musa AEA, Abdarahaman MAA, Mandefield L, Bland M, Aebischer T, Gabe R, Layton AM, Lacey CJN, Kaye PM, Musa AM. Safety and immunogenicity of ChAd63-KH vaccine in post-kala-azar dermal leishmaniasis patients in Sudan. Mol Ther. 2021 Jul 7;29(7):2366-2377. doi: 10.1016/j.ymthe.2021.03.020. Epub 2021 Mar 27.

Drugs

Indications