Research projects overview

MAMAH

Improving maternal and infant health by reducing malaria risks in African women: evaluation of the safety and efficacy of dihydroartemisinin-piperaquine for intermittent preventive treatment of malaria in HIV-infected pregnant women

Fundación Privada Instituto de Salud Global Barcelona (ISGlobal) with partners from Austria, Gabon, Germany, and Mozambique 
Project Coordinator: Prof. Clara Menéndez Santos, ISGlobal, Spain
Starting date: 1 March 2018
Duration: 60 months
Grant amount: EUR 2,985,000
Grant agreement: RIA2016MC-1613

Malaria infection during pregnancy is an important driver of maternal and neonatal health especially among HIV-infected women. In Africa, at least one million pregnancies are co-infected with malaria and HIV annually. The interaction between the two infections is particularly deleterious in pregnancy, leading to increased risk of malaria and HIV viral load, which may increase the frequency of mother to child transmission of HIV (MTCT-HIV). Intermittent preventive treatment in pregnancy (IPTp) with sulphadoxine-pyrimethamine (SP) is recommended for malaria prevention in HIV-uninfected women but it is contraindicated in those HIV-infected on cotrimoxazole prophylaxis (CTXp) due to potential adverse effects.

A recent trial showed that an effective antimalarial added to CTXp and long-lasting insecticide treated nets (LLITNs) in HIV-infected pregnant women improves malaria prevention and maternal health. However, the antimalarial used –mefloquine- was not well tolerated and it was associated with an increase in HIV viral load at delivery and a two-fold increased risk of MTCT-HIV. These findings highlight the need to find alternative drugs with better tolerability and safety profile to prevent malaria in this vulnerable group and to further study the pharmacological interactions between antimalarials and antiretrovirals (ARVs).

The project includes six work packages (WPs). Two of them (WP1 and WP6) relate to the Project Management and Communication, Advocacy and Exploitation activities, whereas WP2, and 3 comprise the main research tasks, and 4 and 5 will address Capacity Building and Networking actions. ISGlobal, as overall Project Coordinator leads the aforementioned WPs 1 and 6.

WP4 is coordinated by Dr Ghyslain Mombo-Ngoma (CERMEL, Gabon) and will have the support of Dr Heimo Lagler (Medical University of Vienna, Austria). The activities included in this work package will contribute to achieving the project objectives through collaboration between the European and African partners involved to develop the technical capacity and infrastructure required to carry out clinical trials for malaria control. Opportunities for capacity building will occur throughout the entire project in an integrated way. More specifically, this work package will:

• Allow investigators and project teams in African sites to gain experience and expertise in new techniques and procedures through infrastructure and technology upgrades.
• Provide training to trial’s staff at all levels in a range of relevant topics including: epidemiology, biostatistics, trial and data management, GCP, GCLP, etc.
• Provide specific training opportunities at the postgraduate level to African research staff through on-site and academic training opportunities.
• Strengthen existing collaboration between African and European institutions, as well as providing opportunities to develop new relationships and future capacity building activities.

Further information can be found on the MAMAH project webpage:

http://www.mamahproject.net/category/the-project/

ASAAP

Clinical evaluation of AntimalarialS tri-therapy with AtovAquone Proguanil for malaria treatment in African children (ASAAP)

Kwame Nkrumah University of Science and Technology (KNUST), Kumasi, Ghana with partners from Benin, Burkina Faso, France, Gabon, Germany, and Mali
Project coordinator: Dr. Oumou Maiga-Ascofare (KNUST), Ghana
Starting date: 01 March 2019
Duration: 48 months
EDCTP grant amount: EUR 7,642,364
Grant agreement: RIA2017MC-2022

ASAAP is a 48-month lasting clinical trial research to evaluate the efficacy, safety, tolerability and pharmacokinetics of a new antimalarial drug combination, with particular focus on its successful application in one of the largest and most vulnerable demographics of Africa – i.e. children 0-5 years old. The overall aim is to develop new antimalarial treatments by combining existing, efficacious medicines for treatment of malaria in African children by promoting African and European research collaboration and strengthening the capacity of African institutions to conduct clinical research.

ASAAP is part of the European and Developing Countries Clinical Trials Partnership 2 (EDCTP2) program supported by the European Union (EU) and receives funding from the German Federal Ministry of Education and Research (BMBF) and the National Institut of Health and Medical Research in France (INSERM).

The project is being led and coordinated by Dr. Oumou Maiga-Ascofaré of the BNITM in Hamburg, Germany and the KCCR in Kumasi, Ghana under the authority of the Kwame Nkrumah University of Science and Technology (KNUST), in collaboration with:

• Dr. Ghyslain Mombo-Ngoma from the Center de Recherches Médicales de Lambaréné (CERMEL) in Lambaréné, Gabon
• Dr. Jerome Clain and Dr. Michel Cot at MERIT (Paris); and Dr. Anna Cohuet at MIVEGEC (Montpellier) from the Institut de Recherche pour le Développement (IRD) in France
• Prof. Abdoulaye Djimde from the Université des Sciences, des Techniques et des Technologies de Bamako (USTTB) in Bamako, Mali
• Prof. Achille Massougbodji from the Institut de Recherche Clinique du Bénin (IRCB) in Abomey-Calavi, Benin
• Dr. Serge Yerbanga from the Institut des Sciences et Techniques (INSTech) in Bobo-Dioulasso, Burkina Faso
• Prof. Jürgen May and Prof. Michael Ramharter from the Bernhard-Nocht-Institut für Tropenmedizin (BNITM) in Hamburg, Germany
• Dr. John Amuasi from KCCR and the department of Global Health at the KNUST School of Public Health in Kumasi, Ghana 

Further information can be found on the EDCTP webpage: http://www.edctp.org/clinical-trials-to-reduce-health-inequities-in-pregnant-women-newborns-and-children-2017/

WANECAM2

A phase II and III clinical trial programme to assess safety, efficacy and transmission-blocking properties of the new antimalarial KAF156 combined with a new formulation of lumefantrine in children and adults with uncomplicated Plasmodium sp. malaria in West and Central Africa

Université des Sciences, des Techniques et des Technologies de Bamako (USTTB), Bamako, Mali, with partners from Burkina Faso, France, Gabon, Germany, the Netherlands, Niger, Sweden, Switzerland, and United Kingdom
Project coordinator: Prof. Abdoulaye Djimdé (USTTB, Mali)
Starting date: 1 March 2019
Duration: 60 months
EDCTP grant amount: EUR 10,000,000
Grant agreement: RIA2017T-2018

WANECAM is the West African Network for Clinical Trials of Antimalarial drugs. This network is being supported by grants from the European & Developing Countries Clinical Trials Partnership (EDCTP).

The WANECAM 2 project aims to accelerate the development of the Ganaplacide/lumefantrine combination for the treatment of uncomplicated malaria by conducting clinical trials in four countries in West and Central Africa: Burkina Faso, Gabon, Mali and Niger. Moreover, and very importantly, the project includes activities around capacity building (e.g. training and infrastructure development) to improve the capabilities in West African countries to develop new antimalarial drugs. The aim is to advance the development of a much-needed new antimalarial therapy while strengthening clinical trial development capabilities in Africa.

The WANECAM 2 project includes participants from West Africa and Europe and is coordinated by Prof Djimde from the University of Bamako. See a full list of our collaborators.

Further information can be found on the WANECAM2 website http://www.wanecam.org/ or on the EDCTP webpage: http://www.edctp.org/news/wanecam-consortium-kicks-off-clinical-study-for-next-generation-antimalarial-drug/