The actual format of the anticipated LEISH3 trial is under review.
The leishmaniases are poverty-related neglected diseases with a major impact on health worldwide. They affect the poorest of the poor and present a severe barrier to socio-economic development. Caused by infection with one of several species of Leishmania parasite, these diseases occur in 98 countries worldwide and can be broadly classified as tegumentary leishmaniases (TL; affecting the skin and mucosa) and visceral leishmaniasis (VL; affecting internal organs). Worldwide, over 1 million reported cases of TL and 0.5 million reported cases of VL occur each year. Whereas TL are chronic and non-life-threatening, VL is responsible for over 20,000 deaths per year, second only to malaria amongst parasites with regard to mortality. Collectively, approximately 2.4 million disability-adjusted life years are lost to the leishmaniases. No vaccines are currently licensed for any form of human leishmaniasis and the drug arsenal is limited and increasingly compromised by drug resistance. .
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Safety of single dose vaccination with ChAd63-KH
Treatment-related adverse events as defined in the clinical trial protocol (median no. events)
Time frame: 12 months from vaccination
Efficacy of single dose vaccination with ChAd63-KH
Frequency of occurrence of PKDL in patients completing treatment with SSG / PM.
Time frame: 12 months from vaccination
Immunological response: T cells
To compare systemic immune responses in vaccine vs placebo arms by measurement of the frequency (median) of gamma-interferon producing T cells
Time frame: 12 months from vaccination
Immunological response: transcriptomics
Comparing transcripts for differential expression in vaccine and placebo arms
Time frame: 12 months from vaccination
Pathogenesis of PKDL comparing Leishmania parasite load pre-vaccination and at PKDL onset
Parasite detection using RNAscope / immunocytochemistry
Time frame: 12 months from vaccination
Immunological response: B cells
Measurement of frequency in vaccinated and placebo groups of B cells by flow cytometry
Time frame: 12 months from vaccination
Immunological response: antibody levels
To compare systemic immune responses in vaccine vs placebo arms by median optical density levels
Time frame: 12 months from vaccination
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