Malaria vaccine first to reach WHO efficacy level in clinical trial

A malaria vaccine undergoing testing has become the first to have reached efficacy levels of 75%, a target set out by the World Health Organisation (WHO).

Researchers from the Jenner Institute - based in the University of Oxford - reported findings from a Phase IIb trial of the malaria vaccine candidate (R21/Matrix-M), showing that the candidate had a 77% efficacy rating. The vaccine is being developed between the University of Oxford and biotechnology company Novavax.

The team is the first to reach the WHO’s Malaria Vaccine Technology Roadmap goal of a vaccine with at least 75% efficacy.

The Phase IIb study was a randomised, controlled and double-blind trial conducted at the Clinical Research Unit of Nanoro (CRUN) / Institut de Recherche en Sciences de la Santé (IRSS), Burkina Faso. There were 450 participants involved, aged between five and 17 months, which were recruited from the catchment area of Nanoro.

During the trial, participants were split into three groups, with the first two groups receiving the vaccine candidate and the third receiving a rabies vaccine as the control group. The trial was held from May 2019 to early August 2019, which was prior to the peak malaria season.

In the higher-dose adjuvant group, the efficacy results were 77%, with 71% being reported in the lower dose adjuvant group over 12 months of follow up.

Now, the researchers are recruiting for a phase III trial which will involve almost 5,000 children across four African countries. The research is being run in collaboration with the with the Serum Institute of India and Novavax.

Halidou Tinto, professor in Parasitology, Regional Director of IRSS in Nanoro, and the trial principal investigator said: “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.”

Adrian Hill, director of the Jenner Institute and Lakshmi Mittal and Family Professor of Vaccinology at the University of Oxford, and co-author of 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% 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.”

Whilst further studies are still needed to ascertain if the vaccine is effective, Lynsey Bilsland from the Wellcome Trust, which helped fund the research, called it “an extremely promising result.”

According to WHO, there were 229 million cases of Malaria in 2019, with 409,000 deaths. Children under five years of age are the most vulnerable group affected by malaria. In 2019, this group accounted for 67% of all worldwide deaths.

The Serum Institute of India estimate that if the vaccine is approved, it will be able to deliver over 200 million doses.

Simon Bland, chief executive officer of the Global Institute for Disease Elimination (GLIDE,) added: “The hugely encouraging results from the Jenner Institute’s recent trial in developing an effective malaria vaccine shows what can be achieved if we continue to invest in research & development. Even before Covid-19, progress in the global fight against malaria had stalled. While twenty countries have eliminated malaria since 2000 and another twenty-five are slated for elimination by 2025, the overall burden of disease remains stubbornly high with over 400,000 deaths each year. This new vaccine could be a game-changer towards the elimination of malaria, a disease that has killed more people than any other since the beginning of humankind.”