Seasonal Mass Vaccination with R21MM to Prevent Malaria in The Gambia and Burkina Faso A Cluster-Randomized Phase 3 Trial Including Booster Dose Evaluation

What this Trial Is About

Researchers are conducting a cluster randomized trial to evaluate the impact of seasonal mass vaccination with the R21Matrix M vaccine on malaria transmission and illness across all ages. The study involves 54 villages in The Gambia and Burkina Faso, comparing villages that receive the vaccination with those that do not. The trial aims to measure malaria prevalence, infection incidence, clinical malaria cases, safety, vaccination coverage, and cost-effectiveness during and after the vaccination seasons. In the intervention villages, all eligible residents will receive three monthly doses of the R21 vaccine from May to July 2024, before the malaria transmission season starts, followed by a booster dose in June 2025. Control villages will continue with standard malaria control measures like seasonal chemoprevention and insecticide-treated bed nets. After each vaccination, a subset of participants will be monitored for side effects and asked to report any illness occurring within 28 days. Participants will be involved in surveys to measure malaria prevalence at peak transmission seasons after the initial and booster vaccinations. Blood samples will be collected from selected individuals to assess malaria infection incidence, and passive case detection will track clinical malaria occurrences during the transmission seasons. Safety monitoring includes collecting reports of adverse events following vaccination. The study will last through the 2025 malaria transmission season, with assessments up to six months after vaccinations.

Seasonal R21 Mass Vaccination for Malaria Elimination