A malaria vaccine, developed by researchers at Oxford University, has demonstrate high-level efficacy of 77% in a phase 2b trial – an ‘extremely positive result’.
Results from a phase 2b trial of the vaccine candidate – R21/Matrix-M – have been published on SSRN/Preprints with The Lancet.
In their findings, the Oxford researchers noted that their vaccine is the first to meet the World Health Organization’s (WHO) goal for a malaria vaccine with at least 75% efficacy.
The phase 2b trial conducted at the Clinical Research Unit of Nanoro (CRUN) in Burkina Faso recruited 450 participants aged five to 17 months from the catchment area of Nanoro, covering 24 villages with an approximate population of 65,000 people.
Two groups were allocated to received the R21/Matrix-M vaccine – either with a low dose or high dose of Novavax’s Matrix-M adjuvant – while the third control group received a rabies vaccine.
In the higher-dose adjuvant group, the vaccine demonstrated 77% efficacy and 71% efficacy in the lower-dose adjuvant group after 12 months of follow-up. No serious adverse events related to the vaccine were observed, the researchers noted.
After these positive results the trial was extended, with a booster vaccination to be administered before the next malaria season one year later.
The Serum Institute of India, that manufactures the vaccine, is confident that it will be able to deliver over 200 million doses of the promising malaria vaccine each year, pending regulatory approval.
“These are very exciting results showing unprecedented efficacy levels from a vaccine that has been well tolerated in our trial programme,” said Halidou Tinto, principal investigator of the trial and professor in parasitology, regional director of CRUN in Nanoro.
“We look forward to the upcoming phase 3 trial to demonstrate large-scale safety and efficacy data for a vaccine that is greatly needed in this region,” he added.
The WHO estimates that malaria causes over 400,000 deaths each year globally, with 229 million cases of clinical malaria reported in 2019.
The majority of malaria deaths occur among children in Africa, where there are very high transmission rates in many countries.
Although over 100 malaria vaccine candidates have entered the clinic in recent decades, research has slowed down in recent years according to the WHO, with no candidates demonstrating the targeted 75% efficacy rate until now.