EVI: European-African partnership to advance the development of a Leishmania vaccine

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EVI: European-African partnership to advance the development of a Leishmania vaccine

On May 16, 2018, Posted by , In News, With Comments Off on EVI: European-African partnership to advance the development of a Leishmania vaccine

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.

European Vaccine Initiative UniversitätsKlinikum Heidelberg • Voßstr. 2, Geb. 4040 • 69115 Heidelberg • Germany Secretariat: Odile Leroy, Executive Director e-mail: odile.leroy@euvaccine.eu, web site: www.euvaccine.eu

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

This project is part of the EDCTP2

Programme supported by the European Contact: Union Dr Odile Leroy European Vaccine Initiative (EVI) Email: communication@euvaccine.eu Phone: +49 6221 565974

PREV_PKDL partners:

The European Vaccine Initiative (EVI, Germany), established in 1998, is a leading product development partnership supporting the development of vaccines for diseases of poverty. EVI has strong experience across a broad portfolio of vaccine candidates in supporting bio manufacturing, phase I and II trials both in Europe and at multiple sites in sub-Saharan Africa. EVI is currently working on malaria, dengue, Zika and other diseases. To date, EVI has achieved to support the development of 34 different vaccine preparations of which 17 were progressed into phase I clinical development. Three vaccine candidates were transitioned to phase II clinical development to partners established in sub-Saharan Africa. EVI has long-standing experience in the coordination and management of large-scale research and clinical development projects, including the coordination of 8 EC and 2 EDCTP funded projects.

University of York (UoY, United Kingdom) is renowned as a research-led university, founded in 1963. Vaccine and immunology research related to this project will be conducted at the Centre for Immunology and Infection (CII), a leading international centre for leishmaniasis research.  Research facilities support state-of-the-art pathogen and immunology research, animal-based research and the use and maintenance of sand fly colonies. A core facility provides imaging, flow cytometer, genomics and bioinformatics support relevant to this project. The CII collaborates with York NHS Teaching Hospital to manage and resource the York Clinical Research Facility, with dedicated space on both sites for supporting volunteer studies of investigational medicinal products and human experimental

European Vaccine Initiative UniversitätsKlinikum Heidelberg • Voßstr. 2, Geb. 4040 • 69115 Heidelberg • Germany Secretariat: Odile Leroy, Executive Director e-mail: odile.leroy@euvaccine.eu, web site: www.euvaccine.eu

medicine research. UoY also houses the York Trials Unit, with expertise in clinical trial design and data management and analysis.

Institute of Endemic Diseases (IEND, Sudan) (legal entity University of Khartoum), government owned facility established in 1993 as a research and training center for endemic diseases. It acts as platform for biomedical and clinical research at Khartoum University. Community service is an ever growing objective, especially for impoverished and remote communities. Objectives of IEND are to undertake research in the major infectious endemic diseases and cancer in Sudan, to train health professionals and scientists in the field of endemic diseases and render services to the neediest communities. Current funders of IEND include Ministry of higher Education (Sudan), WHO and other external agencies. IEND maintains a clinical research centre, The Professor El Hassan Centre for Tropical Medicine at Dooka, and has research facility at Kassab Hospital, both in Gedaref State. A new centre is being built at Um Al Kheir, with DNDi support.

University of Gondar (UoG, Ethiopia), the College of Medicine and Health Sciences (CMHS) at UoG was established in 1954. It is mandated to teach Medicine and Health Sciences students; conducting clinical, basic and community-based research; and rendering healthcare services to more than five million people in the region. It has a teaching and service rendering hospital consisting of clinical wards, leishmaniasis treatment and research center, tuberculosis treatment center, as well as ophthalmology and fistula hospitals with +350 beds and a state-of-the art out-patient clinic. Its clinical laboratory includes pathology and radiology sections offering teaching and diagnostic services. Currently, the college is building a full-fledged Clinical Trial Clinic in Maksegnit town close to Gondar. The clinic has patient examination rooms, a ward and a laboratory. Current research projects at CMHS focus on leishmaniasis, malaria, HIV/AIDS, tuberculosis, schistosomiasis and other diseases. Recently, the CMHS has completed clinical trials on malaria drugs, secondary prophylaxis for HIV/VL patients, and on drugs for intestinal parasitosis. Other clinical trials are currently ongoing.

Kenya Medical Research Institute (KEMRI, Kenya), established in 1979, is the national body responsible for carrying out health research in Kenya. Its key mandates include the cooperation with other relevant organisations and institutions within and outside Kenya engaged in research, training and related activities; dissemination and translation of research findings into evidence-based policy formulation and implementation; and cooperation with national authorities on matters pertaining to research policies and priorities. KEMRI’s Centre for Clinical Research (CCR) has +25 years’ experience in research in leishmaniasis and was instrumental in the establishment of the LEAP platform under which a multicentre clinical trial to evaluate safety and efficacy of Paromomycin (PM) alone or in combination with Sodium Stibogluconate (SSG) led to the WHO recommendation of SSG/PM as first-line treatment for visceral leishmaniasis in East Africa. In addition to clinical trials, CCR together with WHO and European Commission has conducted studies on the development and evaluation of diagnostics for visceral leishmaniasis.

Makerere University (MU, Uganda), established in 1922 and an independent institution since 1970. The College of Health Sciences has the mandate to train students and scientists in infection biology and its applications to infectious diseases control. Research is integrated and spans from basic to applied and operational/clinical research. Several of the research projects, including international collaborations, are supported by international grants. Amudat hospital, the University field site for research and training in leishmaniasis, is a 120-bed hospital located 400km from Kampala in the visceral leishmaniasis endemic region. It serves about 200,000 people, about 1/3 of the beds in the hospital is dedicated for leishmaniasis patients. The hospital laboratory is well equipped and conducts routine diagnostic tests including biochemical and haematology tests. Several clinical trials for anti­leishmanial drugs have been conducted here.

European Vaccine Initiative UniversitätsKlinikum Heidelberg • Voßstr. 2, Geb. 4040 • 69115 Heidelberg • Germany Secretariat: Odile Leroy, Executive Director e-mail: odile.leroy@euvaccine.eu, web site: www.euvaccine.eu

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