See if the R21/Matrix-M malaria vaccine works in real-world settings for kids under 5

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

AVERT is a prospective observational study using a test-negative design to estimate real-world vaccine effectiveness of R21/Matrix-M against clinical malaria in children under 5. The study enrolls eligible children with suspected malaria who are receiving routine care and undergoes blood smear microscopy to classify cases and controls. Vaccination history is captured from records, and adjusted odds ratios are used to calculate vaccine effectiveness. Data collection includes demographics, residence, socioeconomic factors, health access, and malaria prevention practices across approximately 22 outpatient facilities in moderate to high transmission areas. Analyses will compare vaccinated versus unvaccinated children, matched by geography and time, to determine how well vaccination protects against malaria under routine conditions.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Residence in an area where R21/Matrix-M is implemented and within the catchment area of a selected study facility.
* Younger than 5 years and eligibleto receive R21/Matrix-M under the national vaccination schedule at rollout.
* Meets the country definition of suspected malaria, generally axillary temperature of at least 37.5 degrees Celsius or a history of fever within the previous 24 hours, and is undergoing malaria testing.
* Written informed consent provided by an adult caregiver aged 18 years or older.

Exclusion Criteria:

* Caregiver is unable or unwilling to provide informed consent.
* Severe non-malaria illness at presentation that would interfere with study participation.
* Repeat presentation within the protocol-defined exclusion window after a previous enrollment: within 14 days after a microscopy-positive visit; or more than 7 but fewer than 14 days after a microscopy-negative visit. A microscopy-negative visit followed by a positive diagnosis within 7 days will be reclassified as positive rather than treated as a new enrollment.
* Documented receipt of any RTS,S malaria vaccine dose.

Where it's running

• Boromo urbain 1
  Boromo, Boucle Mouhoun, Burkina Faso Recruiting
• Ouahabou
  Boromo, Boucle Mouhoun, Burkina Faso Recruiting
• Béréba
  Houndé, Hauts-Bassins Region, Burkina Faso Recruiting
• Dohoun
  Houndé, Hauts-Bassins Region, Burkina Faso Recruiting
• Kari
  Houndé, Hauts-Bassins Region, Burkina Faso Recruiting
• Déguélin
  Karangasso-Vigué, Hauts-Bassins Region, Burkina Faso Recruiting

Study contacts

• Principal investigator: Isabel Rodriguez-Barraquer, MD, PhD — University of California, San Francisco

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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.