This project is part of the EDCTP2 Programme supported by the European Union (RIA2016V-1640)
European Vaccine Initiative
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 biomanufacturing, 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 successfully supported 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
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 York Biomedical Research Institute, 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 institute 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 medicine research. UoY also houses the York Trials Unit, with expertise in clinical trial design and data management and analysis.
Institute of Endemic Diseases
Institute of Endemic Diseases (IEND, Sudan) (legal entity University of Khartoum), government owned facility established in 1993 as a research and training centre 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
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
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 more than 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
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 anti-leishmanial drugs have been conducted here.