Phase II clinical trials in Sudan of a therapeutic vaccine to prevent post kala azar dermal leishmaniasis to be supported by European & Developing Countries Clinical Trials Partnership
Heidelberg, 16 May 2018
Fresh funding from the European & Developing Countries Clinical Trials Partnership (EDCTP) has been secured by a consortium comprising partners from Europe and Africa to advance the clinical development of a promising vaccine candidate to prevent Post kala azar dermal leishmaniasis (PKDL). PKDL often develops after treatment for visceral leishmaniasis and appears as a chronic dermal manifestation which can significantly affect the quality of life and can result in stigmatisation that has lifetime impact. PKDL patients are also believed to be source of Leishmania infections that lead to outbreaks and epidemics of visceral leishmaniasis. Two phase II clinical trials will be conducted in Sudan to evaluate the safety and efficacy of the vaccine in patients diagnosed with and treated for visceral leishmaniasis. The leishmaniases are one of the world’s most neglected diseases, affecting largely the poorest of the poor, mainly in developing countries, and present a severe barrier to socio-economic development. According to the most recent reports by WHO and CDC, leishmaniases affects people in 98 developing and developed countries with about 350 million people living in these regions. The disease is reported in approximately 12 million people worldwide. Collectively, approximately 2.4M disabilityadjusted life years (DALY) are lost to the leishmaniases. “Vaccines are amongst the most cost-effective tools for prevention and control of many diseases. However, there is no licensed vaccine against any form of human leishmaniasis, while canine vaccines are registered since several years” says Odile Leroy, Executive Director of the European Vaccine Initiative and coordinator of PREV_PKDL.
“Current treatment for leishmaniases is limited to a few drugs characterised by high costs, significant adverse events and, in some cases, increasing parasite drug resistance. Thus, the development of a safe, effective and affordable Leishmania vaccine(s) remains a top priority to defeat the disease”.
The vaccine candidate to be tested within the PREV_PKDL project has been developed at the University of York by Prof Paul Kaye and his team. The vaccine has already been shown to be safe, well tolerated and able to induce a good immune response in healthy subjects and is currently in a further safety study in PKDL patients. In parallel to the two clinical trials in Sudan, the project partners also plan to conduct research studies in different endemic countries (Sudan, Ethiopia, Kenya and Uganda) to better understand the pathogenesis of the disease and the underlying immune mechanisms. The results of these studies, and the development of research capacity for monitoring immune responses, will help to underpin future research and product evaluation. “This funding from EDCTP represents one of the most significant single investments in leishmaniasis vaccine development for many years and it is exciting to see the years of investment in fundamental research beginning to pay off as we move towards the goal of patient benefit” says Paul Kaye. In addition to EDCTP, also the Wellcome Trust is providing support in kind for this study through donation of vaccine for the first clinical trial. The PREV_PKDL project brings together a consortium involving leading institutions from Europe and Africa with proven track records in research and development of products against leishmaniasis, including one public research institution, four universities and one product development partnership. The principal areas of expertise that the partners bring to PREV_PKDL range from discovery research and preclinical R&D, down to the early and mid-stage clinical testing of drugs and vaccines, thereby combining all the expertise and resources required to achieve the objectives of the project. PREV_PKDL furthermore builds on the success and collaborations already established within the Leishmaniasis East Africa Platform (LEAP) that aims at strengthening the clinical research capacity related to leishmaniasis in the region. The four LEAP members involved in PREV_PKDL (Institute of Endemic Diseases (IEND, Sudan), University of Gondar (UoG, Ethiopia), Kenya Medical Research Institute (KEMRI, Kenya) and Makerere University (MU, Uganda)) will take forward the new knowledge and capacities in the development of a safe, efficacious and affordable vaccine for leishmaniasis. Prof Ahmed Musa, Director of IEND says “With the implementation of the PREV_PKDL project we aim to significantly advance the promise of post-chemotherapy vaccination as a tool to control the development of PKDL and significantly enhance the capacity of LEAP countries to support future clinical research programmes including vaccine and drug trials”.
Quick Facts about PREV_PKDL:
Start Date: 01 April 2018
End Date: 30 June2023
Coordinator: Odile LEROY, European Vaccine Initiative
Project Funding: EDCTP2
Total Funding: 8M EUR
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