EDCTP2: European & Dev. Countries Clinical Trials Partnership 2015 - 2019

The EDCTP2 programme is in its completion phase, no new annual work plan or new calls have been published and the EDCTP Secretariat has focused on reviewing periodic and final reports, tracking the progress of projects, collecting outputs, and managing amendment requests. As previously reported, the EDCTP2 programme was planned to run until the end of 2024, but due to the COVID-19 pandemic, the end of the programme has been extended until the end of 2026 to allow completion of all project grants (no-cost extensions of project duration). Likewise, Sida has extended the end date of the activity period of the agreement with the EDCTP Association until the end of 2026. Examples of project results The EDCTP2 programme has adhered to its strategic vision and continues to deliver significant impact on poverty-related diseases and clinical research capacity in sub-Saharan Africa. In the end of 2023, 24 out of 48 projects supported by Sida had reached their end date and were completed. Most completed grants were COVID-19 projects but also ethics and regulatory grants as well as career development fellowships. Research area: Vaccine and neutralising antibody development for disease prevention In October 2023, the World Health Organization (WHO) recommended the use of the new malaria vaccine R21/Matrix-M for the prevention of malaria in children, and in Dec 2023, the vaccine was added to the WHO list of prequalified vaccines. R21/Matrix-M is the second malaria vaccine recommended by WHO after the RTS,S/AS01 vaccine which received WHO recommendation in 2021. Both vaccines, R21/Matrix-M and RTS,S/AS01, were developed with support from EDCTP2. The Sida-supported Multi-Stage Malaria Vaccine Consortium (https://www.euvaccine.eu/malaria-vaccines/mmvc) progressed the clinical development of R21/Matrix-M in phase I and II trials that generated promising results enabling further evaluation in a phase III multicenter trial. Noteworthy, key trial data were generated in Burkina Faso where the study was led by Prof. Tinto who was highlighted by Nature as one of ten people who helped shape science in 2023 (Nature's 10; www.nature.com/immersive/d41586-023-03919-1/index.html) Demand for malaria vaccines is unprecedented; however, the available supply of RTS,S is limited. The addition of R21/Matrix-M to the list of WHO-recommended malaria vaccines is expected to result in sufficient vaccine supply to benefit all children living in areas where malaria is a public health risk. The R21/Matrix-M vaccine is an easily deployable vaccine that can be manufactured at mass scale and modest cost, enabling as many as hundreds of millions of doses to be supplied to countries which are suffering a significant malaria burden. In combination with public health measures, such as the use of insecticide-treated bed nets and seasonal malaria chemoprevention strategies, this vaccine can help save and improve the lives of millions of children and their families. 15 African countries are expected to introduce malaria vaccines in 2024, and countries plan to reach around 6,6 million children with the malaria vaccine in 2024 and 2025. The new vaccine has been authorised by Ghana, Nigeria, Burkina Faso and the Central African Republic, and many other African countries are preparing to receive shipments Far from all vaccine trials result in the licensing of new vaccines but still provide important evidence and insights for future trials and vaccine development. In December 2023, the Sida-supported PrEPVacc trial testing the efficiency of different HIV-1 vaccine regimens at four clinical research centers in South Africa, Tanzania and Uganda was stopped because the interim analysis showed no efficacy in the prevention of HIV-1 infection. The results were communicated rapidly and transparently to all stakeholders and will inform decisions about the development of future vaccines. Research area: Drugs for treatment and prevention Malaria during pregnancy can cause serious maternal and newborn health issues, especially in women living with HIV. WHO recommends daily doses of the antibiotic co-trimoxazole to prevent malaria in pregnant women living with HIV residing in areas with high malaria transmission. However, the efficacy of this preventive treatment in sub-Saharan Africa is threatened because malaria parasites are becoming increasingly resistant to the drug. The Sida-supported IMPROVE project performed clinical trials in Kenya and Malawi showing that the addition of the antimalarial drug dihydroartemisininpiperaquine to daily co-trimoxazole substantially reduces the risk of malaria infection in pregnancy in areas of high resistance (publication in The Lancet in January 2024; https://doi.org/10.1016/S0140-6736(23)02631-4). This finding together with findings of another EDCTP-funded project that performed similar trials in Gabon and Mozambique are expected to be incorporated in the WHO guidelines for treatment and prevention of malaria in pregnancy. Capacity development As previously reported, Sida supported the call Capacity development for disease outbreak and epidemic response in sub-Saharan Africa, in collaboration with Africa CDC. The aim of this call is to help establishing an African cohort of epidemiologists and biostatisticians through grants supporting institutions in sub-Saharan Africa and Europe that provide Masters degree training in epidemiology and biostatistics as part of Africa CDCs framework for public health workforce development. The Sida-funded projects MSc EpiBiostat and SCEPRESSA support 15 students each from DRC and Kenya, respectively. In the MSc EpiBiostat project, the Kinshasa School of Public Health has enrolled 15 health professionals (5 women and 10 men) from the Congolese Ministry of Heath into its Masters training programme. Fellows are expected to complete their studies in 2024. The SCEPRESSA project is providing Masters training in Epidemiology and Biostatistics to 15 early to mid-career researchers (7 women and 8 men) who enrolled in January 2022 at the Jomo Kenyatta University of Agriculture and Technology (JKUAT) in Kenya. All the fellows successfully completed their course work and have taken up field placements and research activities during the second year of the project. Fellows are expected to complete their studies in 2024. The importance of local and regional expertise in epidemiology and biostatistics has been evident during the COVID-19 pandemic and needs to be highlighted again in light of the recent mpox outbreak in Africa. In addition to the above and other Sida-supported EDCTP fellowship programmes, Sida-supported research projects included 221 sub-Saharan African trainees at Bachelor (7), Master (109), PhD (80), postdoctoral (11) and other (14) level. Of the trainees, 104 were females (47%) and 117 males (53%) and gender balance is similar across the different trainee levels. Publications In August 2024, the EDCTP Secretariat recorded 263 scientific publications associated with Sida-funded projects (out of 1494 EDCTP2 publications from all grants). Although most of the clinical studies are ongoing, publication numbers have grown steadily over the last three years. This upward trend is expected to continue as more and more clinical trials complete and results emerge. Of the 263 publications, 253 (96%) are peer-reviewed journal articles and 4% are preprints and other non-peer reviewed publications. Publications cover the following topics: emerging diseases (65%), HIV and HIV-associated infections (19%), followed by TB and malaria (8% and 5% respectively). The high number of publications on emerging diseases including COVID-19 is the result of substantial Sida investment in this topic.

To accelerate research and development of new or improved diagnostics, drugs, microbicides and vaccines against HIV/AIDS, tuberculosis, malaria and NIDs.