This trial is designed to assess the therapeutic efficacy and safety of CHAd63-KH, a new candidate Leishmania vaccine, in patients with persistent PKDL. 100 participants will be randomly assigned (50 participants in each arm) to receive placebo or ChAd63-KH 7.5 x10(10)vp. Doses will be administered at a single time point.
This study is a randomised, double blinded, placebo controlled trial designed to assess the therapeutic efficacy and safety of CHAd63-KH, a new candidate Leishmania vaccine, in patients with persistent PKDL. 100 participants will be randomly assigned (50 participants in each arm) to receive placebo or ChAd63-KH 7.5 x10(10)vp intramuscular injection into the deltoid region. Doses will be administered at a single time point. Volunteers aged between 12-50 years with persistent PKDL will be recruited at Professor El-Hassan's Centre for Tropical Medicine, Dooka, Gedarif State, Sudan, and will be followed up for 120 days after the dosing visit. The trial is planned to run for 24 months. Secondary objectives are as follows: 1. To compare the humoral and cellular immune responses generated by the candidate vaccine in patients with persistent PKDL. 2. To observe any clinical changes in the cutaneous PKDL disease over a 120 day period following vaccination
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
86
Institute of Tropical Medicine
Doka, Gedarif, Sudan
To assess the number of participants with treatment-related adverse events as defined in the clinical trial protocol V1.0.
To assess the number of participants with treatment-related adverse events as defined in the clinical trial protocol V1.0.
Time frame: 24 months
To assess the therapeutic efficacy of CHAd63-KH, a new candidate, in patients with PKDL by clinical judgement of PKDL lesion reduction.
To assess the therapeutic efficacy of CHAd63-KH, a new candidate, in patients with PKDL by clinical judgement of PKDL lesion reduction.
Time frame: 24 months
Immune responses by presence of interferon gamma producing T cells
To identify cellular immune responses generated by the candidate vaccine in patients with persistent PKDL using a gamma interferon ELISpot assay
Time frame: 24 months
Immune responses by presence of serum antibodies against Leishmania peptides
To identify humoral immune responses generated by the candidate vaccine in patients with persistent PKDL using a gamma interferon ELISpot assay
Time frame: 24 months
Clinical changes in PKDL disease
To observe any changes in the appearance of the cutaneous PKDL disease over a 120 day period following vaccination.
Time frame: 24 months
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