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A randomized double-blind Phase IIb trial to evaluate the efficacy of ChAd63-KH for the treatment of post kala-azar dermal leishmaniasis

ABSTRACT: A randomized double-blind Phase IIb trial to evaluate the efficacy of ChAd63-KH for the treatment of post kala-azar dermal leishmaniasis

PROVIDER: PRJNA1106492 | ENA |

REPOSITORIES: ENA

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			Action	DRS
	SRR28853300.fastq.gz	Fastqsanger.gz
	SRR28853301.fastq.gz	Fastqsanger.gz
	SRR28853302.fastq.gz	Fastqsanger.gz
	SRR28853303.fastq.gz	Fastqsanger.gz
	SRR28853304.fastq.gz	Fastqsanger.gz

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A randomized double-blind Phase IIb trial to evaluate the efficacy of ChAd63-KH for the treatment of post kala-azar dermal leishmaniasis

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Project description:In the present study, we carried out in-depth proteomic analysis of a clinical isolate of post kala-azar dermal leishmaniasis (PKDL) L. donovani promastigotes. The high-resolution mass spectrometry data was searched against protein database of L. donovani. This resulted in identification of 5, 283 unique proteins in L. donovani accounting for 61% of L. donovani proteome. This is one of the most in-depth proteome profile of L. donovani as well as across the different Leishmania species analyzed till date.

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Project description:In a recent phase 2a clinical trial, the candidate leishmaniasis vaccine ChAd63-KH was shown to be safe and immunogenic in Sudanese patients with post kala-azar dermal leishmaniasis (PKDL). However, its value as a stand-alone therapeutic was unknown. To assess the therapeutic efficacy of ChAd63-KH, we conducted a randomized, double-blind, placebo-controlled phase 2b trial (ClinicalTrials.gov: NCT03969134). Primary outcomes were safety and efficacy (≥90% improvement in clinical disease). Secondary outcomes were change in severity grade and vaccine-induced immune response. 86 participants with uncomplicated PKDL of ≥6 month duration were randomized to receive ChAd63-KH (7.5 × 1010 viral particles, once by the intramuscular route) or placebo. 75 participants (87%) completed the trial as per protocol. No severe or serious adverse events were observed. At day 90 post-vaccination, 6/40 (15%) and 4/35 (11%) participants in the vaccine and placebo groups, respectively, showed ≥90% clinical improvement (risk ratio [RR] 1.31 [95% confidence interval (CI), 0.40-4.28], p = 0.742). There were also no significant differences in PKDL severity grade between study arms. Whole-blood transcriptomic analysis identified transcriptional modules associated with interferon responses and monocyte and dendritic cell activation. Thus, a single vaccination with ChAd63-KH showed no therapeutic efficacy in this subset of Sudanese patients with PKDL.

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