The RH5.1/Matrix-M blood-stage vaccine could constitute a crucial secondary defence for communities at high risk of malaria infection, including those who have already received pre-erythrocytic vaccines, an analyst has said.
Commenting on a recent Phase IIb trial on the first blood-stage malaria vaccine, GlobalData infectious disease analyst Stephanie Kurdach said: “RH5.1/Matrix-M has the potential to be the first blood-stage malaria vaccine brought to market. This could be a much-needed addition to the currently available malaria vaccines and provide an important second line of defence for those most at risk of contracting malaria.”
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The study, published in The Lancet Infectious Diseases earlier this month, demonstrated that RH5.1/Matrix-M – the first blood-stage malaria vaccine – is safe, effective and highly immunogenic. The double-blind, randomised, controlled, Phase IIb trial was carried out by researchers in Burkina Faso and the UK, and it comprised 361 children between the ages of 5 and 17 months.
The trial’s success suggests it could become part of a broader malaria vaccine strategy, complementing pre-erythrocytic vaccines, which work by targeting the early sporozoite stage of the parasite. Both of the malaria vaccines prequalified by the World Health Organisation (WHO) and recommended for use in children are pre-erythrocytic.
These are GSK’s Mosquirix (recommended since 2021) and Serum Institute of India’s R21/Matrix-M (recommended since 2023).
As immunity wanes with time, sporozoites can infect the liver, leading to blood-stage clinical malaria infection. A blood-stage malaria vaccine, such as RH5.1/Matrix-M, could therefore provide a second line of defence.
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By GlobalDataIn the Phase IIb trial, RH5.1/Matrix-M was found to be 55% effective against clinical malaria when administered in a delayed third-dose regimen. It also demonstrated 80% efficacy against high levels of malaria parasites.
Considering the results within the context of the broader vaccine trials landscape, Kurdach commented: “According to GlobalData, there are 11 other malaria vaccines currently in Phase II development, including pre-erythrocytic vaccines and blood-stage vaccines from manufacturers such as BioNTech, GSK, the National Institute of Allergy and Infectious Diseases and Vac4All SAS. No new malaria vaccines are in Phase III development or pre-registration at this time.”
According to the WHO, there were around 263 million malaria cases in 2023 and 597,000 deaths. Cases were spread across 83 countries, but 94% of these were in Africa, which also saw 95% of malaria deaths. Safe and effective vaccines for children are a priority as under-fives account for about 76% of all malaria deaths in Africa.
