EVI initiates a new clinical trial to protect pregnant women against malaria
- EVI
- Apr 7
- 2 min read
European Vaccine Initiative (EVI) has launched a Phase II clinical trial in Mali to evaluate the R21/Matrix-M malaria vaccine, developed by University of Oxford, in women of childbearing potential. The findings could support an expanded indication for the vaccine, helping to protect a highly vulnerable population from malaria.
20 March 2025
On March 12, 2025, the first participants were enrolled in a new clinical trial in Mali, that will test the R21/Matrix-M vaccine against malaria in women of child-bearing potential. The trial, funded by EVI, marks an important milestone towards protecting pregnant women, a neglected and forgotten population group, against malaria.
A significant unmet medical need remains in addressing malaria during pregnancy which can lead to maternal anaemia, stillbirth, preterm delivery, low birth weight, and increased infant mortality. Pregnant women, particularly those in malaria-endemic regions, are among the most vulnerable to the disease due to physiological changes that heighten susceptibility.
To address this gap, EVI , the University of Oxford, and Malaria Research & Training Center (MRTC) in Mali initiated a Phase II clinical trial to evaluate the safety, immunogenicity, and efficacy of the R21/Matrix-M malaria vaccine in healthy women of childbearing potential (WOCBP). This double-blind, randomised study will enrol 330 participants.
Participants will be closely monitored over two years to assess vaccine efficacy against malaria infection, immune response, and safety outcomes.
R21/Matrix-M is a protein subunit vaccine designed to protect against Plasmodium falciparum, the deadliest malaria-causing parasite. It targets the circumsporozoite protein (CSP) of the parasite and is formulated with the Matrix-M adjuvant to enhance immune responses. The R21/Matrix-M vaccine is currently only licensed for children in several sub-Saharan African countries.
The results could help determine whether the vaccine can be safely administered to women planning pregnancy, offering protection against malaria in a highly vulnerable population and addressing a long-standing global health challenge.
NCT06080243 study receives support from Directorate-General for International Cooperation of the Netherlands (DGIS). - https://clinicaltrials.gov/study/NCT06080243
Picture Credit: Seventy Four