NCT03969134

A Study to Assess the Safety, Efficacy and Immunogenicity of Leishmania Vaccine ChAd63-KH in PKDL

A Phase IIb Study to Assess the Safety, Efficacy and Immunogenicity of the Leishmania Vaccine ChAd63-KH in Post-kala Azar Dermal Leishmaniasis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 86 (actual)
• Sponsor: University of York · Academic / Other
• Sex: All
• Age: 12 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• Leishmaniasis, Cutaneous

Interventions

Type	Name	Description
BIOLOGICAL	ChAd63-KH	The vaccine will be injected intramuscularly into the arm.
OTHER	Placebo	The placebo will be injected intramuscularly into the arm.

Timeline

• Start date: 2020-04-06
• Primary completion: 2022-08-31
• Completion: 2023-02-28
• First posted: 2019-05-31
• Last updated: 2023-05-26

Locations

1 site across 1 country: Sudan