Assessing Vaccine Effectiveness of R21/Matrix-M Across Malaria Transmission Settings (AVERT)

The AVERT study is a prospective observational test-negative case control study evaluating the real-world effectiveness of the R21/Matrix-M malaria vaccine among children younger than 5 years in Burkina Faso and Uganda. Children who seek outpatient care with suspected malaria and are eligible for the national R21/Matrix-M vaccination program will be enrolled. Malaria infection will be determined by blood smear microscopy. Children with a positive microscopy result will be classified as cases and children with a negative result as controls. Vaccination history, including the number and timing of doses, will be obtained primarily from vaccination cards or other written records. Vaccine effectiveness will be estimated by comparing the odds of vaccination among cases and controls.

NCT Number	NCT07749911
Lead Sponsor	Clinton Health Access Initiative Inc. Collaborators: University of California, San Francisco, Infectious Diseases Research Collaboration, Uganda, Institut de Recherche en Sciences de la Sante, Burkina Faso, Ministry of Health, Burkina Faso, Ministry of Health, Uganda
Conditions	Malaria, PLASMODIUM FALCIPARUM MALARIA
Enrollment	20,000 participants
Start Date	2026-07-14
Primary Completion	2027-06 (estimated)
Study Completion	2027-08 (estimated)
Updated on ClinicalTrials.gov	2026-08-06