Venkatraman, N., et al. Evaluation of a novel malaria anti-sporozoite vaccine candidate, R21 in Matrix-M adjuvant, in the UK and Burkina Faso: two phase 1, first-in-human trials.

Lancet Microbe, 2024 Dec 17:100868. PMID: 39805302.

Comments from Desert King: The R21/Matrix-M malaria vaccine uses Novavax’s proprietary Matrix-M adjuvant technology to help prevent malaria in children. The R21 Ag was developed by the University of Oxford and the Serum Institute of India (SII). The vaccine has been reported to be well tolerated, with fever and injection site pain being the most common side effects. The vaccine has shown high, up to 75% efficacy. Based on the efficacy data and safety profile, this low cost vaccine was prequalified by the World Health Organization (WHO) in December 2023.

This paper summarizes the safety data from two phase 1, first-in-human R21/Matrix-M malaria trials (a phase 1a open-label study and a phase 1b randomized controlled trial – NCT02572388 and NCT02925403, respectively).

In the Phase 1a study, 239 adverse events occurred; in the Phase 1b study, 12 adverse events were recorded among study groups. Vaccinations were well tolerated, and most local and systemic adverse events were mild. No serious adverse events were deemed related to vaccination, and the two serious adverse events were unlikely to be related to the vaccine. The paper demonstrates that the R21 with Matrix-M adjuvant has an acceptable safety profile.

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