Two ways to give the R21/MM malaria vaccine during seasonal malaria campaigns in Chad
Cluster Randomised Non-inferiority Trial Comparing Malaria Incidence When Implementing R21/Matrix-M Synchronized With Seasonal Malaria Chemoprevention Distribution Versus R21/Matrix-M Given Routinely Through the EPI in Two Health Districts in Chad (CoSAV-R21)
This project will test whether giving the R21/MM malaria vaccine together with seasonal malaria chemoprevention protects young children in Chad better than giving the vaccine through the routine immunization program.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 70000 (estimated) |
| Ages | 6 Months to 59 Months |
| Sex | All |
| Sponsor | Epicentre Academic / other |
| Locations | 1 site (Moïssala, Mandoul Region) |
| Trial ID | NCT07038837 on ClinicalTrials.gov |
What this trial studies
This cluster-randomized phase IV trial in the Moïssala and Dembo districts of Chad randomizes 26 health-centre catchment areas ('zones of responsibility') 1:1 to two delivery strategies. The Routine arm delivers a four-dose R21/MM schedule through the national EPI program to infants aged 6–11 months, while the Synchronized arm delivers the same four-dose schedule alongside annual seasonal malaria chemoprevention to children aged 6–59 months. The trial compares real-world protective efficacy and impact on malaria incidence between the two approaches. Outcomes include vaccine effectiveness and programmatic feasibility of synchronizing vaccination with SMC in areas of high seasonal transmission.
Who should consider this trial
Good fit: Children living in participating villages in the Moïssala and Dembo districts whose parents consent — specifically infants 6–11 months for the routine arm and children 6–59 months for the synchronized arm during the SMC rounds — are ideal candidates.
Not a fit: Children with known severe hypersensitivity to a previous malaria or hepatitis B vaccine or to any component of R21/MM, and those outside the eligible age ranges, are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, synchronizing R21/MM delivery with SMC could increase vaccine coverage and reduce malaria cases and hospitalizations among young children in seasonal transmission areas.
How similar studies have performed: Previous trials of R21/MM in seasonal settings have shown promising protection in young children, and this trial tests whether that benefit translates into routine program delivery when synchronized with SMC.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
* • Routine arm
1. Aged 6 to 11 months at the time of the first R21/MM vaccination (dose 1).
2. Residing in a village participating in the study and randomized to the routine arm.
3. Oral consent provided by the child's parent/guardian.
* Synchronised arm
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1. Aged 6 to 59 months at the time of the first R21/MM vaccination (dose 1) during the first 3 rounds of SMC (2025).
2. Residing in a village participating in the study and randomized to the synchronized arm.
3. Oral consent provided by the child's parent/guardian.
Exclusion Criteria:
* Exclusion criteria for both arms according to Chad national EPI guidelines
Malaria vaccine is not recommended for children with known severe hypersensitivity:
* To a previous dose of a malaria vaccine
* To a previous dose of hepatitis B vaccine
* One of the components of the R21/MM vaccine
Mild illness - including respiratory tract infections, mild diarrhoea and fever below 38.5° C - is not a contraindication to R21/MM vaccination. Malnutrition and being HIV-seropositive are also not contraindications to R21/MM vaccination.
Where this trial is running
Moïssala, Mandoul Region
- Medecin sans Frontières — Moïssala, Mandoul Region, Chad (Recruiting)
Study contacts
- Study coordinator: Jessica SAYYAD, Dr
- Email: jessica.sayyad@epicentre.msf.org
- Phone: +331 40 21 55 55
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.