作者
Brima M Younis, Mohamed Osman, Eltahir AG Khalil, Francesco Santoro, Simone Furini, Rebecca Wiggins, Ada Keding, Monica Carraro, Anas EA Musa, Mujahid AA Abdarahaman, Laura Mandefield, Martin Bland, Toni Aebischer, Rhian Gabe, Alison M Layton, Charles JN Lacey, Paul M Kaye, Ahmed M Musa
发表日期
2021
期刊
Molecular Therapy
出版商
Elsevier
简介
Post-kala-azar dermal leishmaniasis (PKDL) is a chronic, stigmatizing skin condition occurring frequently after apparent clinical cure from visceral leishmaniasis. Given an urgent need for new treatments, we conducted a phase IIa safety and immunogenicity trial of ChAd63-KH vaccine in Sudanese patients with persistent PKDL. LEISH2a (ClinicalTrials.gov: NCT02894008) was an open-label three-phase clinical trial involving sixteen adult and eight adolescent patients with persistent PKDL (median duration, 30 months; range, 6–180 months). Patients received a single intramuscular vaccination of 1 × 1010 viral particles (v.p.; adults only) or 7.5 × 1010 v.p. (adults and adolescents), with primary (safety) and secondary (clinical response and immunogenicity) endpoints evaluated over 42–120 days follow-up. AmBisome was provided to patients with significant remaining disease at their last visit. ChAd63-KH vaccine …
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