- R21/Matrix-M becomes the second malaria vaccine candidate ever to start a phase III licensure trial
- This builds on the recent finding of high level efficacy of this vaccine in a phase IIb trial in children in Burkina Faso, published today in The Lancet
- The first phase III trial doses were administered by the team at the Malaria Research and Training Centre, Bamako, Mali, one of five trial sites across West and East Africa
- The malaria vaccine was designed at the Jenner Institute, University of Oxford, who have partnered with the Serum Institute of India for commercial development
The annual death toll from malaria is over 400,000, with most of these deaths amongst children in sub-Saharan Africa. There has been little improvement noted in the last 5 years despite the large amounts of funding allocated to bed nets, insecticide spraying and antimalarial drugs. An efficacious vaccine is needed to try and reach the WHO goal of reducing malaria deaths by at least 90% by 2030.
R21/Matrix-M, a malaria vaccine developed at the Jenner Institute, University of Oxford, showed efficacy of 77% over 12 months in a recently reported phase IIb trial. First vaccinations have now begun in Mali in a larger phase III trial which is hoped to lead to licensure of this malaria vaccine by 2023. This phase III trial will assess efficacy and safety in 4800 children across five sites in Burkina Faso, Kenya, Mali and Tanzania. This is a double-blind, randomised, controlled trial where participants, aged 5-36 months, will receive three vaccinations 4 weeks apart and a booster vaccination 1 year later. The vaccine is being assessed in areas of differing malaria transmission and seasonality.
The University of Oxford has partnered with Serum Institute of India Pvt Ltd. (SIIPL) for the manufacturing of R21/Matrix-M to ensure provision of low high volumes of low-cost vaccine, and access in countries where it is required the most. SIIPL has confirmed its commitment to the provision of >200 million doses per year after licensure, which will be adequate supply for children most at risk of malaria in sub-Saharan Africa.
Professor Adrian Hill, Director of the Jenner Institute, University of Oxford said: "The start of a phase III licensure trial is always an import milestone in the development of a vaccine. This large malaria trial is the culmination of many years of laboratory research and assessment of numerous candidate vaccines in early-stage clinical trials with large numbers of collaborators."
Professor Alassane Dicko, Head of the Bougouni Clinical Research Unit, MRTC-P, USTTB and Malian Principal Investigator said: "We are very pleased to see the enthusiasm with which the communities of Bougouni received the first doses of this new candidate malaria vaccine. We are hopeful that the encouraging Phase 2 results will be confirmed in this larger Phase 3 trial".
Professor Abdoulaye Djimdé, Director of the Malaria Research and Training Centre - Parasito (MRTC-P), University of Science, Techniques and Technologies of Bamako (USTTB), said: "We are thrilled to be the first site to enroll volunteers in the Phase 3 trial of this very promising R21 vaccine. We will utilize our more than two decades of experience in malaria vaccine testing towards successful completion of this trial"
Professor Halidou Tinto, Principal Investigator of the Nanoro, Burkina Faso trial site, said: "This is a very important moment in the development of the R21 malaria vaccine candidate. We hope that the public-private partnership behind this pivotal Phase III trial will confirm the high efficacy and good safety profile seen in our phase II trial in Nanoro. The five African institutions involved in this partnership have here a historic role to play. We are all committed to work hard in order to generate data that will provide regulators and policy makers with the evidence needed to support the registration of this vaccine. If successful, this vaccine should be made available as quickly as possible to complement existing malaria prevention tools''
Professor Jean Bosco Ouedraogo, Principal Investigator at The Institute of Sciences and Techniques in Bobo-Dioulasso, Burkina Faso said: "The R21 vaccine is a promising malaria prevention tool to help accelerate malaria elimination, particularly in high burden countries in Africa. The Phase II trial demonstrated high vaccine efficacy in children and I'm proud that it was done in Burkina Faso. I am really happy to be part of this key new trial to evaluate the vaccine's safety and efficacy in an area of perennial transmission near Bobo-Dioulasso."
Dr Umesh Shaligram, Chief Scientist at the Serum Institute of India said: "Malaria has been one of the most difficult diseases to make an effective vaccine against. We are committed to ensuring that the supply of this very promising vaccine, manufactured here in Pune, India, meets public health needs by supplying over 200 million doses annually."
The World Health Organisation (WHO) estimates that malaria causes over 400,000 deaths each year globally and progress in reducing malaria mortality has stalled in recent years. Most deaths are amongst children in Africa where very high transmission rates are found in many countries.
229 million cases of clinical malaria were reported in 2019. Current malaria control measures include the use of insecticide treated bed net, insecticide spraying and seasonal malaria chemoprevention where drug are administered monthly to children at time of highest transmission. No vaccine has been licensed for widespread use although efforts to develop vaccines have spanned over fifty years.
Over 100 malaria vaccine candidates have entered clinical trials over recent decades but none has previously shown the >75% efficacy targeted by World Health Organization's Malaria Vaccine Technology Roadmap. It is likely that an effective vaccine could add to the current control measures and have significant impact. Vaccines could have many applications: reduction of disease and death in malaria endemic areas; contributions to malaria elimination and eventual eradication; protection of malaria-naïve travellers to malaria-endemic regions.
About Vaccine Clinical Trials
About Vaccine Clinical Trials
Vaccine clinical trials are used to test if new vaccines are safe and effective. A phase I trial aims to test the safety of a new vaccine, a phase II tests the new vaccine to see if it is safe and effective and a phase III tests this in larger numbers to provide further safety and efficacy data.
About the University of Science, Techniques and Technologies of Bamako, Mali
The Malaria Research and Training Center - Parasitology Section (MRTC-P) within the University of Science, Techniques and Technologies of Bamako, is a renowned African-led research institution which is divided into several research units, including the Bougouni and Ouelessebougou Clinical Research Units and many others. During the past 20 years, MRTC-P in collaboration with the US National Institutes of Health, University of Maryland, EDCTP, Wellcome Trust, London School of Hygiene and Tropical Medicine, University of Oxford, African Academy of Sciences, WHO and others has built state-of-the-art facilities including several clinical research sites, parasite culture facilities, insectaries, genomic data storage and bioinformatics facilities.
About the Jenner Institute:
The Jenner Institute is based within the Nuffield Department of Medicine, University of Oxford, and is headquartered at the Old Road Campus Research Building, in Headington, Oxford. The Jenner Institute also supports senior vaccine scientists, known as Jenner Investigators, within many other departments across the University of Oxford, as well as externally within The Pirbright Institute and the Animal and Plant Health Agency.
The Jenner Institute brings together investigators who are designing and developing numerous vaccines to generate an exceptional breadth of scientific know-how and critical mass, whilst still allowing the individual investigators to remain independent and accountable to their funders and stakeholders.
The Jenner Institute is supported by the Jenner Vaccine Foundation, a UK registered charity and is advised by the Jenner Institute Scientific Advisory Board.
About the University of Oxford
About the University of Oxford
Oxford University has been placed number 1 in the Times Higher Education World University Rankings for the fifth year running, and at the heart of this success is our ground-breaking research and innovation.
Oxford is world-famous for research excellence and home to some of the most talented people from across the globe. Our work helps the lives of millions, solving real-world problems through a huge network of partnerships and collaborations. The breadth and interdisciplinary nature of our research sparks imaginative and inventive insights and solutions.
Through its research commercialisation arm, Oxford University Innovation, Oxford is the highest university patent filer in the UK and is ranked first in the UK for university spinouts, having created more than 200 new companies since 1988. Over a third of these companies have been created in the past three years.