EDCTP-funded trial of R21/Matrix-M malaria vaccine shows efficacy of 77%
Positive results from an EDCTP-funded clinical trial in Burkina Faso, published as a preprint with The Lancet, demonstrate that the malaria vaccine candidate R21/Matrix-M is safe, immunogenic and has an efficacy of 77%, exceeding the WHO goal of 75% efficacy for malaria vaccines.
“We congratulate the Multi-stage Malaria Vaccine Consortium on these highly promising results from the Burkina Faso trial of R21. This study represents a key advance in the clinical development of the R21 malaria vaccine towards licensure, and an important step closer to malaria control and elimination.”
Dr Michael Makanga, EDCTP Executive Director
The Multi-Stage Malaria Vaccine Consortium
MMVC – the Multi-Stage Malaria Vaccine Consortium – aims to develop the first multi-stage vaccine for malaria, designed to target all four life cycle stages of the Plasmodium falciparum parasite. EDCTP has been funding the ground-breaking research of this Europe-Africa malaria vaccine consortium, led by Professor Hill (University of Oxford), for more than a decade. The consortium which includes leading researchers from Europe, Africa and India is conducting a series of trials in Burkina Faso, Kenya, Sierra Leone, and Tanzania, supported by a grant of 15 million euros from EDCTP.
This week, the team reported highly promising results from the phase Ib/IIb trial of R21/Matrix-M in Burkina Faso led by the clinical trial investigator, Professor Halidou Tinto of the Institute of Research in Health Sciences (IRSS) in Burkina Faso. In this trial, children aged 5-17 months were randomised to receive either the R21/Matrix-M candidate (low- or high-dose) or a control vaccine (rabies). Vaccine efficacy of 77% was seen in the higher-dose adjuvant group, and 71% in the lower-dose adjuvant group over 12 months of follow-up, with no serious adverse events related to the vaccine noted. Preparations for a large-scale phase III trial are underway.
More information
- University of Oxford news item: Malaria vaccine becomes first to achieve WHO-specified 75% efficacy goal
- SSRN/Preprints with The Lancet publication: Datoo, Mehreen S. and Magloire Natama, Hamtandi and Somé, Athanase and Traoré, Ousmane and Rouamba, Toussaint and Bellamy, Duncan and Yameogo, Prisca and Valia, Daniel and Tegneri, Moubarak and Ouedraogo, Florence and Soma, Rachidatou and Sawadogo, Seydou and Sorgho, Faizatou and Derra, Karim and Rouamba, Eli and Orindi, Benedict and Ramos-Lopez, Fernando and Flaxman, Amy and Cappuccini, Federica and Kailath, Reshma and Elias, Sean C. and Mukhopadhyay, Ekta and Noe, Andres and Cairns, Matthew and Lawrie, Alison and Roberts, Rachel and Valéa, Innocent and Sorgho, Hermann and Williams, Nicola and Glenn, Gregory and Fries, Louis and Reimer, Jenny and Ewer, Katie J. and Shaligram, Umesh and Hill, Adrian V. S. and Tinto, Halidou, High Efficacy of a Low Dose Candidate Malaria Vaccine, R21 in 1 Adjuvant Matrix-M™, with Seasonal Administration to Children in Burkina Faso (April 20, 2021). Available at SSRN.
- Health Europa: R21/Matrix-M malaria vaccine becomes first to reach 75% efficacy target.
- EDCTP | M. Blazquez Domingo and Michelle Helinski, ‘The EDCTP portfolio of malaria projects’.