Two ways to give the R21/MM malaria vaccine during seasonal malaria campaigns in Chad

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.