Safety and immunogenicity of ChAd63-KH vaccine in post-kala-azar dermal leishmaniasis patients in Sudan.

ABSTRACT: 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 evaluate

SUBMITTER: Younis BM 

PROVIDER: S-EPMC8261165 | biostudies-literature | 2021 Jul

REPOSITORIES: biostudies-literature