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EDCTP malaria portfolio: large investments in treatment and vaccines

25 April 2019

The World Malaria Report 2018 states that after an unprecedented period of success in global malaria control, progress has stalled. Data from 2015–2017 show no significant progress in reducing global malaria cases. In 2017 there were still an estimated 219 million cases and 435 000 related deaths in 2017. In addition to the existing control and elimination efforts, scaling up of malaria research and innovation is necessary, including developing new and improved drugs and regimens to address emerging drug resistance, as well as vaccines, diagnostics and vector control research & development (R&D). The fight against malaria requires combined and integrated approaches which necessitates a concerted effort of many partners.

EDCTP has supported the campaign for a world free of malaria since the programme was established in 2003. Our European-African partnership prioritises research and development on novel and improved drugs and drug combinations, studies in high-risk populations such as children and pregnant women, malaria patients with co-infections, and the effects of genetic diversity in the African populations. For prevention, we invest in chemo-prevention for high-risk populations and development of second-generation vaccines against both Plasmodium falciparum and P. vivax malaria.

“The burden of malaria on the lives of the very young and their mothers, as well as HIV co-infected individuals – especially in sub-Saharan Africa – is heart breaking. EDCTP is grateful and proud to have scaled up its investment in both malaria and vaccines R&D by introducing a portfolio approach to support the development of the next generation of malaria treatments and vaccines.”

Dr Michael Makanga, EDCTP Executive Director

EDCTP investments in malaria-related projects, 2014-2019
The above infographic shows the malaria investment in proportion to the portfolio. For more detail, please download a PDF here. Currently, grant agreement preparations are ongoing for clinical evaluation of drugs and vaccines against malaria based on a portfolio approach.

 

EDCTP-FUNDED RESEARCH PROJECTS

WANECAM 2: novel malaria treatment combination
The West African Network for Clinical Trials of Antimalarial Drugs (WANECAM), a consortium of ten academic organisations in Africa and Europe, has just started the ‘WANECAM 2’ study. EDCTP invests EUR 10 million in the project. WANECAM will conduct clinical trials of a novel antimalarial combination comprising KAF156 (ganaplacide) and lumefantrine in a new once-daily formulation.

The project is led by Professor Abdoulaye Djimdé of the University of Sciences, techniques and Technologies of Bamako, Mali. The consortium will collaborate with the not-for-profit product development partnership Medicines for Malaria Venture (MMV) and the pharmaceutical company Novartis to develop its compound KAF156 in combination with lumefantrine.

MMVC: aiming for a four-stage vaccine
A malaria vaccine will be an essential tool in malaria control and elimination. With encouraging progress in malaria vaccine development, MMVC (Multi-Stage Malaria Vaccine Consortium (MMVC) will test a novel vaccine combination targeting four stages of the malaria parasite life cycle, aiming to develop a candidate four-stage vaccine with 75% efficacy. EDCTP invested EUR 15 million in the project, which received a total of EUR 20 million.

The four-stage vaccine will include a next generation version of RTS,S, known as R21; a liver-stage vaccine that has shown positive results in EDCTP-funded trials; a promising vaccine targeting a key protein involved in red blood cell invasion, PfRH5; and a vaccine targeting a key protein in the final bloodstream form, Pfs25. Results from a series of controlled human infection studies – using new capacity in Africa – and pilot trials will inform the design of an appropriate vaccination strategy. This will be tested in a phase II trial in infants in sites of different levels of malaria transmission.

The consortium is led by Prof. Adrian Hill (University of Oxford, United Kingdom) and involves institutions in Burkina Faso, France, India, Kenya, the Netherlands, Sierra Leone, Sweden and Tanzania.

PYRAPREG: new treatment option for malaria in pregnancy
Malaria in pregnancy is a major cause of maternal anaemia and low birth weight, resulting in significant maternal and infant mortality/morbidity, poor growth and infant development. Though artemisinin-based combination therapies (ACT) are currently recommended for the treatment of malaria in the 2nd and 3rd trimesters of pregnancy, their tolerability, safety and efficacy vary considerably, limiting treatment options.

Pyronaridine-artesunate (PA), the latest ACT registered, is well tolerated in children and non-pregnant adults for single and repeated treatment. Although PA has shown good safety and tolerability profile in pre-clinical studies, there is insufficient information to recommend its use during pregnancy. The PYRAPREG (Efficacy and safety of a newly registered artemisinin-based combination (pyronaridine-artesunate – Pyramax®) for the treatment of uncomplicated malaria in African pregnant women) aims to establish whether pyronaridine-artesunate presents an alternative treatment option for African pregnant women (2nd or 3rd trimester) with uncomplicated falciparum malaria. The study aims to provide this  information necessary for inclusion this ACT in the guidelines for management of malaria during pregnancy.

EDCTP invests more than EUR 7 million in the project which is led by Dr Kassoum Kayentao (University of Sciences, Techniques and Technologies of Bamako in Mali. The study is a three-arm multicentre randomised open label trial in five African countries (Burkina Faso, Mali, The Gambia, the Democratic Republic of the Congo and Mozambique).  Other partners are institutions in the Netherlands, Spain and the United Kingdom.

ASAAP: delaying ACT resistance
Funded under the same EDCTP 2017 Call for proposals (Clinical trials to reduce health inequities in pregnant women, newborns and children), the ASAAP study is a large clinical study evaluating a triple plus combination of antimalarials for children.

In view of the growing risk of drug-resistance, new combination treatments with three or more compounds will be developed to delay or prevent resistance. The ASAAP study will assess the efficacy of artesunate-amodiaquine (ASAQ) in combination with atovaquone–proguanil (AP), a triple-therapy for treatment of uncomplicated malaria in African children.

The study is coordinated by Dr. Oumou Maiga-Ascofare of the Kumasi Centre for Collaborative Research at the Kwame Nkrumah University of Science and Technology in Kumasi, Ghana. It is conducted in collaboration with six research institutions in Benin, Burkina Faso, France, Gabon, Germany and Mali. EDCTP is investing EUR 7.6 million in the project, which has additional funding from the German Federal Ministry for Education and Research (BMBF).

 

COUNTRIES WITH EDCTP-FUNDED MALARIA RESEARCH 2014-2019

The below map shows all countries involved in EDCTP-funded malaria studies with number of grants. For more detail, please download a PDF here.

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