A new malaria vaccine developed by researchers at Oxford University and partners is the first to have achieved the World Health Organization (WHO) roadmap efficacy goal of 75 percent, marking a turning point for a potential malaria vaccine to make it into the arms of those that need it in the near future.
Malaria remains a daunting global health concern. Figures by the WHO have shown that in 2019 alone 229 million cases were reported around to world, with an estimated 409,000 deaths due to the mosquito-borne infectious disease. Children under the age of 5 are the most vulnerable, accounting for 67 percent of the global deaths in 2019 alone.
Researchers tested the latest malaria vaccine for safety and efficacy in a cohort of children. The phase IIb randomized, controlled, double-blind trial took place at the Clinical Research Unit of Nanoro (CRUN) / Institut de Recherche en Sciences de la Santé (IRSS) in Burkina Faso and involved 450 children, aged between 5 to 17 months, from nearby villages.
The children were split into 3 groups: a high dose malaria vaccine group, a low dose malaria vaccine group, and a control group that received a rabies vaccine instead.
The findings are reported in a preprint for the Lancet, which means the results still need to be peer-reviewed – however, positive outcomes have been reported. The phase IIb clinical trial has shown the malaria vaccine by Oxford University is 77 percent effective at the higher dose over a 12-month follow-up period, whereas the lower dose was 71 percent effective. No adverse health outcomes were reported and the vaccine was well tolerated.
"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 III trial to demonstrate large-scale safety and efficacy data for a vaccine that is greatly needed in this region," said Halidou Tinto, Professor in Parasitology, Regional Director of IRSS in Nanoro, and the trial Principal Investigator in a statement.
A larger phase III trial is now starting recruitment to test for safety and efficacy in a larger cohort of 4,800 children aged 5 to 36 months across four African countries, which, if successful, could mean that a viable malaria vaccine is on the horizon.
"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 an critical global health challenge." Lynsey Bilsland from Wellcome, who helped fund the research, added.