R21 malaria vaccine plus seasonal malaria chemoprevention for young children in West Africa

Integrating Malaria Vaccine With Seasonal Malaria Chemoprevention in West Africa

This project will test whether giving the R21 malaria vaccine together with seasonal malaria chemoprevention prevents clinical malaria in young children in Burkina Faso and Mali.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40000 (estimated)
• Ages: 3 Months to 59 Months
• Sex: All
• Sponsor: Epicentre (Academic / other)
• Locations: 2 sites (Ouagadougou and 1 other locations)
• Trial ID: NCT06860178 on ClinicalTrials.gov

What this trial studies

This is a multi-site, phase-4, cluster-randomised non-inferiority trial in Burkina Faso and Mali where health centre catchment areas are randomised to different vaccine delivery strategies. One arm delivers the 3-dose R21/Matrix-M primary series aligned with seasonal malaria chemoprevention (SMC) for children aged 3–59 months, while the comparator arm uses country-specific routine EPI or pre-SMC campaign delivery for children aged 5–36 months. Effectiveness will be measured by clinical malaria incidence as well as vaccine coverage, acceptability, and operational feasibility under real-world conditions. Clusters are followed through the malaria season to compare health and programmatic outcomes between the integrated and routine delivery approaches.

Who should consider this trial

Good fit: Ideal candidates are children aged 3–59 months who live in the catchment area of a participating health centre in Burkina Faso or Mali and whose parent or guardian can give written consent.

Not a fit: Children with known chronic illnesses, a history of severe allergic reactions to vaccines, or those living outside participating catchment areas are unlikely to receive benefit from participation.

Why it matters

Potential benefit: If successful, this integrated approach could reduce malaria cases in young children and simplify delivery by combining vaccination with existing SMC campaigns.

How similar studies have performed: Previous trials of R21/Matrix-M have shown promising efficacy in seasonal settings, but combining R21 delivery with SMC in routine programmatic delivery is largely untested.

Eligibility criteria

Inclusion criteria:

Control arms :

* Children aged 5-36 months in Burkina Faso and Mali at the time of first study vaccination;
* Resident in the catchment area of a health centre assigned to the control arm;
* Willingness to comply with the study procedures;
* Written informed consent from Parent/Guardian.

Intervention arms :

* Children aged 3-59 months at the time of first study vaccination;
* Resident in the catchment area of a health centre assigned to the intervention arm;
* Willingness to comply with the study procedures;
* Written informed consent from Parent/Guardian.

Exclusion Criteria:

1. History of allergic disease or reactions likely to be exacerbated by any component of the Vaccines;
2. Any history of anaphylaxis in relation to vaccination;
3. Known chronic illness;
4. Any other significant disease, disorder or situation which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial;
5. History of vaccination with another malaria vaccine. -

Where this trial is running

Ouagadougou and 1 other locations

• Institut de Recherche en Sciences de la Santé, Direction Régionale du Centre-Ouest — Ouagadougou, Burkina Faso (Recruiting)
• University of Sciences Techniques and Technologies of Bamako — Bamako, Mali (Recruiting)

Study contacts

• Study coordinator: Valérie Briand

Conditions Malaria Vaccine; malaria; CPS; pediatric; vaccine; R21