Implementation trial Mali
Malaria transmission is highly seasonal in Mali. It was previously shown that combination of I) administration of R21/Matrix-M malaria vaccine in infancy, followed by yearly vaccine booster doses immediately prior to the start of the transmission season, and II) implementation of seasonal malaria chemoprevention (SMC) with sulphadoxine-pyrimethamine plus amodiaquine (SP+AQ), during the peak period of malaria risk, reduced the malaria incidence in children under 5 years of age as compared to SMC alone. However, there are concerns that uptake of the boosters will remain relatively low due the conceived view of caregivers that all important childhood vaccinations are completed by the end of a child’s first year of life. Therefore, there is ongoing debate about the best approach to deliver these seasonal booster doses. The main objective of this study in Mali is thus to investigate whether annual booster doses of R21/Matrix-M administered pre-transmission season through an active mass community campaign (intervention area) will achieve better coverage and a greater reduction in incidence of malaria than (passive) provision thereof at routine Essential Programme on Immunization (EPI) programme vaccination centres (control area). This is a pragmatic implementation study, involving two cohorts of children. Two areas that have comparable malaria epidemiology, social structure, coverage of EPI vaccines, and access to treatment have been identified in Mali from the list of districts that were selected for the initial roll out of R21/Matrix-M vaccine by the Mali Ministry of Health. This project will provide important information on the optimum delivery of malaria vaccine booster doses in settings of seasonal malaria transmission, which could save many lives.
Study design
Phase IV/implementation research will be used for this study, with Kignan as the intervention district and Kolondieba as the control district.
Group (districts) | Strategy for vaccine booster delivery | Timing of vaccine booster delivery | Primary outcomes |
---|---|---|---|
Control (Kolondieba) |
Routine EPI clinics |
Pre-transmission season (June) |
Vaccine booster coverage, malaria incidence |
Intervention (Kignan) |
Mass campaign (community-based) |
Pre-transmission season (June) |
Vaccine booster coverage, malaria incidence |