Phase II Trial of Two Different Doses of R21Matrix-M Booster Vaccine in School Children in Burkina Faso

What this Trial Is About

Researchers are evaluating the safety and immune response of different doses of a malaria booster vaccine called R21Matrix-M in school children aged 6 to 8 years who previously received four doses of the vaccine in an earlier trial in Burkina Faso. This trial is a double-blind, randomized Phase II study that aims to find the best booster dose to protect children against Plasmodium falciparum malaria. The study is sponsored by the University of Oxford and will run from February 2026 to March 2027. Participants will be randomly assigned to receive one dose of either 5b5g or 10b5g of the R21Matrix-M vaccine, which contains a protein and an adjuvant that helps stimulate the immune system. The lower dose is the standard pediatric dose, while the higher dose is the standard adult dose. Each child will get one booster shot, and the study will compare the safety and immune responses between these two dose groups. During the study, researchers will monitor participants closely for any side effects for up to 28 days after vaccination and check serious adverse events for one year. Blood samples will be taken before vaccination and at one, six, and twelve months afterward to measure immune responses. The total participation lasts about one year after the booster dose, with ongoing safety and health assessments throughout this period.

Dose Finding Trial of R21/Matrix-M in School Children