Study of Malaria Vaccine R21 Combined With Seasonal Malaria Chemoprevention in Young Children in West Africa

What this Trial Is About

Researchers are evaluating the effectiveness and real-life impact of a new way to deliver the R21 malaria vaccine combined with seasonal malaria chemoprevention SMC in children living in areas with highly seasonal malaria transmission in Burkina Faso and Mali. This Phase 4, two-arm cluster-randomized trial compares two vaccination approaches in children within defined health center areas, measuring clinical malaria cases, vaccine coverage, acceptability, feasibility, and cost-effectiveness. Children in the control group will receive the R21 vaccine through routine EPI vaccination either year-round for ages 5 to 36 months in Burkina Faso or as an annual campaign before malaria season and SMC delivery in Mali. The intervention group will receive a three-dose primary vaccine series aligned with SMC distribution during an annual campaign, covering children aged 3 to 59 months. These approaches aim to assess different delivery strategies of the R21Matrix-M vaccine alongside SMC. Participants will be monitored through routine malaria surveillance to track clinical malaria incidence. Cross-sectional surveys will check for malaria parasites in the community. Researchers will also assess vaccine coverage, acceptability, feasibility, adverse events, stakeholder perceptions, behavioral factors affecting vaccine uptake, and cost-effectiveness over periods ranging from 4 months up to 36 months after enrollment. The primary outcome is malaria incidence in children aged 5 to 36 months over 12 months from enrollment.

Integrating Malaria Vaccine With Seasonal Malaria Chemoprevention in West Africa