An investigational malaria vaccine was hailed Friday as providing “unprecedented levels of efficacy” to meet the WHO-specified goal of 75% efficacy and is now set to enter the next phase of studies, in collaboration with the Serum Institute of India, to deliver its doses in the coming years.
Researchers at the University of Oxford and partners reported the results of a Phase IIb study of the malaria vaccine candidate R21 / Matrix-M to say it was 77% effective over 12 months of follow-up.
Researchers, in collaboration with the Serum Institute of India and Novavax Inc, have now begun recruiting for a Phase III licensing study to evaluate large-scale safety and efficacy in 4,800 children, aged 5 to 36. months, in four African countries.
“These are very exciting results that show unprecedented levels of efficacy from a vaccine that was well tolerated in our trial program,” said Halidou Tinto, Professor of Parasitology, IRSS Regional Director at Nanoro and Principal Investigator of the study.
Researchers report vaccine efficacy of 77% in the higher-dose adjuvant group and 71% in the lower-dose adjuvant group, over 12 months of follow-up, with no vaccine-related serious adverse events noted.
The World Health Organization (WHO) Malaria Vaccine Technology Roadmap goal for a vaccine is set at 75% effectiveness.
“These new findings support our high expectations for the potential of this vaccine, which we believe is the first to meet the WHO goal of a malaria vaccine with at least 75% efficacy,” said the co-author of the study. article Adrian Hill, Director of the Jenner Institute and Lakshmi Mittal & Family Professor of Vaccinology at the University of Oxford.
“With the commitment of our business partner, the Serum Institute of India, to produce at least 200 million doses per year over the next few years, the vaccine has the potential to have a major impact on public health if licensed,” he said.
Cyrus and Adar Poonawalla, president and chief executive officer of the Serum Institute of India, said they were “very excited” to see the results of a safe and highly effective malaria vaccine that will be available worldwide through the collaborative effort.
“The Serum Institute is committed to global disease burden reduction and disease elimination strategies by providing high-volume, affordable vaccines. We are highly confident that we will be able to deliver more than 200 million doses per year in line with the above strategy as soon as approved regulations are available, “they said.
In the published “Lancet” study, the authors report from their randomized, controlled, double-blind phase IIb study conducted at the Clinical Research Unit of Nanoro (CRUN) / Institut de Recherche en Sciences de la Sant & # 233; (IRSS), Burkina Faso, where 450 participants, aged between 5 and 17 months, were recruited from the Nanoro catchment area, covering 24 villages and a population of approximately 65,000.
Participants were divided into three groups, with the first two groups receiving R21 / Matrix-M (with a low or high dose of the Matrix-M adjuvant) and the third, a rabies vaccine as the control group. Doses were administered from early May 2019 to early August 2019, largely before the peak of the malaria season.
Following these results, the Phase IIb study, funded by the European Union-supported EDCTP2 program, was extended with a booster vaccination administered before the next malaria season one year later.
Lynsey Bilsland, of Wellcome, who helped fund the research, said: “Despite global efforts against malaria, too many lives are still lost to this disease, especially infants and young children. Vaccines could change that.” .
“This is an extremely promising result that shows the high efficacy of a safe, low-cost and scalable vaccine designed to reach the huge number of children who are most at risk of the devastating impact of malaria. Although more studies are needed,” this marks a significant and exciting step forward on a critical global health challenge, ”Bilsland said.
Professor Charlemagne Ouedraogo, Minister of Health, Burkina Faso said: “Malaria is a leading cause of infant mortality in Africa. We have supported trials on a number of new candidate vaccines in Burkina Faso and these new data show that in the coming years could be the birth of a very useful new vaccine against malaria. It would be an extremely important new tool to control malaria and save many lives “.