An under-trial malaria vaccine was on Friday hailed as delivering “unprecedented efficacy levels” to achieve the WHO specified goal of 75 per cent efficacy and is now set to enter the next stage of trials, in collaboration with the Serum Institute of India, to deliver its doses in the coming years.
Researchers from the University of Oxford and partners reported the findings from a Phase IIb trial of the candidate malaria vaccine R21/Matrix-M to say that it had proved to be 77 per cent effective in over 12-months of follow-up.
The researchers, in collaboration with the Serum Institute of India and Novavax Inc, have now started recruitment for a Phase III licensure trial to assess large-scale safety and efficacy in 4,800 children, aged 5-36 months, across four African countries.
“These are very exciting results showing unprecedented efficacy levels from a vaccine that has been well tolerated in our trial programme,” said Halidou Tinto, Professor in Parasitology, Regional Director of IRSS in Nanoro, and the trial Principal Investigator.
The researchers report a vaccine efficacy of 77 per cent in the higher-dose adjuvant group, and 71 per cent in the lower dose adjuvant group, over 12 months of follow-up, with no serious adverse events related to the vaccine noted.
World Health Organization’s (WHO) Malaria Vaccine Technology Roadmap goal for a vaccine is set at 75 per cent efficacy.
“These new results support our high expectations for the potential of this vaccine, which we believe is the first to reach the WHO’s goal of a vaccine for malaria with at least 75 per cent efficacy,” said co-author of the paper Adrian Hill, Director of the Jenner Institute and Lakshmi Mittal & Family Professor of Vaccinology at the University of Oxford.
“With the commitment by our commercial partner, the Serum Institute of India, to manufacture at least 200 million doses annually in the coming years, the vaccine has the potential to have major public health impact if licensure is achieved,” he said.
Cyrus and Adar Poonawalla, Chairman and CEO of the Serum Institute of India, said they were “highly excited” to see the results on a safe and highly effective malaria vaccine which will be available to the whole world through the collaborative effort.
“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 annually in line with the above strategy as soon as regulatory approvals are available,” they said.
In the ‘Lancet’ published study, the authors report from their Phase IIb randomised, controlled, double-blind trial conducted at the Clinical Research Unit of Nanoro (CRUN) / Institut de Recherche en Sciences de la Santé (IRSS), Burkina Faso, where 450 participants, aged 5-17 months, were recruited from the catchment area of Nanoro, covering 24 villages and an approximate population of 65,000 people.
The participants were split into three groups, with the first two groups receiving the R21/Matrix-M (with either a low dose 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 prior to the peak malaria season.
Following these results, the Phase IIb trial, which was funded by the EDCTP2 programme supported by the European Union, was extended with a booster vaccination administered prior to the next malaria season one year later.
Lynsey Bilsland, from Wellcome, which helped fund the research, said: “Despite global efforts against malaria, too many lives are still lost to this disease, especially babies and young children. Vaccines could change this.”
“This is an extremely promising result showing high efficacy of a safe, low-cost, scalable vaccine designed to reach the huge numbers of children who are most at risk of the devastating impact of Malaria. Whilst further studies are required, this marks a significant and exciting step forward on a critical global health challenge,” Bilsland said.
Professor Charlemagne Ouedraogo, Minister of Health, in Burkina Faso said: “Malaria is one of the leading causes of childhood mortality in Africa. We have been supporting trials of a range of new vaccine candidates in Burkina Faso and these new data show that licensure of a very useful new malaria vaccine could well happen in the coming years. That would be an extremely important new tool for controlling malaria and saving many lives.”