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)

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

This is a two-arm, cluster-randomised, phase IV trial conducted in Chad to assess the protective efficacy and impact in real-life conditions of a new strategy for administering the R21/MM malaria vaccine, synchronized within a seasonal malaria chemoprevention (SMC) campaign, among children living in areas of high seasonal malaria transmission. In this study, a cluster is defined as the catchment area of a primary care health centre. In Chad, each catchment area is known as a 'zone of responsibility' (French: Zone de Responsibilité' \[ZR\]). Twenty-six (26) of the total 27 ZRs in the districts of Moïssala and Dembo will be randomized in a 1:1 ratio to receive a 4-dose (3 primary doses + 1 booster) R21/MM schedule either (1) integrated into the routine EPI vaccination program (the Routine control arm), or (2) synchronized with an annual seasonal malaria chemoprevention (SMC) campaign (the Synchronized intervention arm). Malaria incidence: R21/MM effectiveness will be assessed using the incidence of biologically confirmed clinical malaria (trial primary endpoint). The incidence of clinical malaria will be determined through enhanced surveillance of malaria cases in health centres and hospitals over a 17-month period (August 2025 - December 2026). Coverage surveys: Cross-sectional surveys (cluster sampling) will be carried out to measure R21/MM vaccine coverage, SMC coverage, coverage of other malaria prevention measures, and coverage of other EPI vaccines. Nested case-control study: A sub-sample of children admitted to Moïssala District Hospital with severe clinical malaria will be offered the opportunity to participate in a nested case-control study designed to estimate the individual protective efficacy of R21/MM against severe malaria.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6 months
Maximum Age: 4
Healthy Volunteers: t
View:

• • Routine arm

‣ Aged 6 to 11 months at the time of the first R21/MM vaccination (dose 1).

⁃ Residing in a village participating in the study and randomized to the routine arm.

⁃ Oral consent provided by the child's parent/guardian.

∙ Synchronised arm

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‣ Aged 6 to 59 months at the time of the first R21/MM vaccination (dose 1) during the first 3 rounds of SMC (2025).

⁃ Residing in a village participating in the study and randomized to the synchronized arm.

⁃ Oral consent provided by the child's parent/guardian.

Locations
Other Locations
Chad
Medecin sans Frontières
RECRUITING
Moïssala
Contact Information
Primary
Jessica SAYYAD, Dr
jessica.sayyad@epicentre.msf.org
+331 40 21 55 55
Backup
San Maurice OUATTARA
San-Maurice.OUATTARA@epicentre.msf.org
+235 85 15 76 18
Time Frame
Start Date: 2025-06-16
Estimated Completion Date: 2028-06
Participants
Target number of participants: 70000
Treatments
No_intervention: Routine arm (control)
primary series (3 doses) of R21/Matrix M administered throughout the year as part of the routine Expanded Programme on Immunisation (EPI), followed by a single booster six months after the 3rd dose.
Experimental: Synchronised arm (intervention)
primary series (3 doses) of R21/MatrixM synchronized with a seasonal malaria chemoprevention (SMC) campaign, followed by a single booster 12 months after 1st dose was introduced.
Related Therapeutic Areas
Sponsors
Collaborators: Chad Ministry of Public Health National Malaria Control Programme (NMCP), Epicentre, Paris, France., Liverpool School of Tropical Medicine, Chad Ministry of Public Health Expanded Programme on Immunisation (EPI)
Leads: Epicentre

This content was sourced from clinicaltrials.gov