Low-Cost Malaria Vaccine found Efficacious in The Lancet Journal study

Key Study Details:

• Design: Double-blind, randomized, phase 3 trial conducted across five sites in four African countries.

• Participants: Enrolled children aged 5–36 months, randomly assigned to receive R21/Matrix-M or a control rabies vaccine.

• Dosing: Three doses administered 4 weeks apart, with a booster at 12 months.

• Endpoints: Primary objective focused on protective efficacy at seasonal and standard sites over 12 months after completing the primary series.

Key Findings:

• Efficacy: The R21/Matrix-M vaccine exhibited a 75% efficacy at seasonal sites and 68% at standard sites against the first clinical malaria episode, with a reduction of 868 and 296 cases per 1000 children-years, respectively.

• Safety: Well-tolerated, with injection site pain and fever as the most common adverse events. No treatment-related deaths occurred, and adverse events did not significantly differ between vaccine groups.

• Antibody Response: Vaccine-induced antibodies targeting the conserved circumsporozoite protein correlated with efficacy. Higher antibody titers were observed in the 5–17 month age group, showing the highest efficacy.

The R21/Matrix-M malaria vaccine emerges as a low-cost, high-efficacy solution, earning WHO policy recommendation and prequalification. With its acceptance by several African countries and promising results in reducing clinical malaria, this breakthrough marks a significant stride in combating the malaria burden in sub-Saharan Africa.

Reference:

Mehreen S Datoo, DPhil, Alassane Dicko, PhD *, Halidou Tinto, PhD *, Jean-Bosco Ouédraogo, MD, Mainga Hamaluba, MD, Ally Olotu, DPhil et al.Safety and efficacy of malaria vaccine candidate R21/Matrix-M in African children: a multicentre, double-blind, randomised, phase 3 trial. The Lancet, 2024. https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(23)02511-4/fulltext#%20