PREV_PKDL

PREV_PKDL is a collaborative project funded by the European & Developing Countries Clinical Trials Partnership (EDCTP2) Programme supported by the European Union. The project is the joint effort of leading European and African experts with proven track records in research and development of products against leishmaniasis.

Start Date: 01 April 2018

End Date: 30 June 2023

Coordinator: Odile LEROY, European Vaccine Initiative, Germany

Project Founder: EDCTP2

Total Funding: 8M EUR

The PREV_PKDL project aims at advancing the clinical development of ChAd63-KH vaccine for the prevention of post kala azar dermal leishmaniasis (PKDL). We will evaluate ChAd63-KH in two clinical trials in clinically cured visceral leishmaniasis (VL) patients: i) a dose escalation, age de-escalation phase IIa safety study, and ii) a phase IIb safety and efficacy study, powered to detect a reduction in PKDL incidence. The results of these trials will be decisive in the future development of ChAd63-KH.

Additionally, to better understand the disease as well as drug and vaccine responses, multidimensional, multiparameter phenotyping will be conducted on patient cohorts recruited across the countries of the Leishmaniasis East Africa Platform (LEAP; Ethiopia, Kenya, Sudan and Uganda). Launched in 2003 with the support of the Drugs for Neglected Diseases initiative (DNDi), LEAP brings together scientists and institutions in East Africa to develop clinical trial capacity to bring new treatment options to Leishmaniasis patients in this region. A major aim of PREV_PKDL is to support LEAP in its ambitions, by extending its research capacity in immunology and vaccine development. This will be achieved through a program to strengthen immunology research capacity through the development of a flow cytometry network across LEAP. This capacity strengthening will help LEAP to develop as a major force for research and training on poverty-related neglected diseases in the East African Region.

logo EDCTPThis project is part of the EDCTP2 Programme supported by the European Union (RIA2016V-1640)