A malaria vaccine that has achieved efficacy of 77 percent in children in Burkina Faso has become the first to meet the World Health Organisation’s Malaria Vaccine Technology Roadmap target of 75 percent, researchers in Burkina Faso and from the University of Oxford in the UK, have reported.
The researchers reported last week that 450 participants, between five months and 17 months old, were recruited in Nanoro in central Burkina Faso, covering 24 villages and a population of about 65,000.
The double-blind trial was conducted at the Clinical Research Unit of Nanoro (CRUN) / Institut de Recherche en Sciences de la Santé (IRSS) in Burkina Faso.
In their findings, the researchers said that the vaccine candidate, R21/Matric-M, showed “favourable safety profile and was well-tolerated”, adding that it had “excellent potential for large-scale manufacturing and low-cost supply”.
The researchers found a vaccine efficacy of 77 percent in the higher dose ancillary group, and 71 percent in the lower dose adjunct group over 12 months of follow-up, “with no serious adverse events related to the vaccine”.
Following these results, the second phase trial, which was funded by a European Union grant, was extended with a booster vaccination administered before the next malaria season one year later.
Halidou Tinto, a Burkinabe Professor in Parasitology, who is Regional Director of IRSS in Nanoro and the trial Principal Investigator, said: “The researchers, in collaboration with the Serum Institute of India and Novavax Inc., have now started recruitment for a phase three licensure trial to assess large-scale safety and efficacy in 4,800 children, aged five to 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.
“We look forward to the upcoming phase three trial to demonstrate large-scale safety and efficacy data for a vaccine that is greatly needed in this region.”
Prof Charlemagne Ouédraogo, the 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.”
Burkina Faso’s Minister of Higher Education, Scientific Research and Innovation, Prof Alkassoum Maiga, said: “I am proud of Burkina Faso researchers who made a great contribution to reach this important milestone.
“I hope that the upcoming phase three trial will confirm these exciting findings and that this vaccine could have a real impact on this disease affecting millions of children every year.”
Adrian Hill, Director of the Jenner Institute and Professor of Vaccinology at the University of Oxford, who co-authored the paper, said: “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 percent efficacy.
“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.”
According to the WHO, more than 100 malaria vaccine candidates have entered clinical trials in recent decades but none has shown the targeted 75 percent efficacy.
There were 229 million cases of clinical malaria recorded in 2019 and the WHO estimates that malaria causes more than 400,000 deaths each year globally, noting that progress in reducing malaria mortality had stalled in recent years.
Most deaths are among children in Africa where very high transmission rates are found in many countries, the WHO said.