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RECRUITING
NCT07749911

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

Sponsor: Clinton Health Access Initiative Inc.

View on ClinicalTrials.gov

Summary

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.

Official title: Real-World Effectiveness of the R21/Matrix-M Malaria Vaccine in Children in Burkina Faso and Uganda

Key Details

Gender

All

Age Range

5 Months - 5 Years

Study Type

OBSERVATIONAL

Enrollment

20000

Start Date

2026-07-14

Completion Date

2027-08

Last Updated

2026-08-06

Healthy Volunteers

No

Interventions

BIOLOGICAL

R21/Matris-M Malaria vaccine

R21/Matrix-M vaccination received through routine national immunization programs. The study will record the number and dates of doses received. Children will be classified as having received 0, 1, 2, 3, or 4 eligible doses, with prespecified grouped classifications used if individual dose categories are underpowered. Doses given fewer than 14 days before malaria testing will not count toward the primary exposure classification.

Locations (21)

Boromo urbain 1

Boromo, Boucle Mouhoun, Burkina Faso

Ouahabou

Boromo, Boucle Mouhoun, Burkina Faso

Béréba

Houndé, Hauts-Bassins Region, Burkina Faso

Dohoun

Houndé, Hauts-Bassins Region, Burkina Faso

Kari

Houndé, Hauts-Bassins Region, Burkina Faso

Déguélin

Karangasso-Vigué, Hauts-Bassins Region, Burkina Faso

Karangasso-Vigué

Karangasso-Vigué, Hauts-Bassins Region, Burkina Faso

Sourmousso

Karangasso-Vigué, Hauts-Bassins Region, Burkina Faso

Wara

Karangasso-Vigué, Hauts-Bassins Region, Burkina Faso

Mankarga T

Zorgo, Oubri, Burkina Faso

Mankarga V3

Zorgo, Oubri, Burkina Faso

Mankarga V6

Zorgo, Oubri, Burkina Faso

Kitgum-Matidi HCIII

Kitgum, Acholi, Uganda

Namokora HCIV

Kitgum, Acholi, Uganda

Lalogi HCIV

Omoro, Acholi, Uganda

Rwenyawawa HCIII

Kikube, Bunyoro, Uganda

Nawaikoke HCIII

Kaliro, Busoga, Uganda

Kigandalo HCIV

Mayuge, Busoga, Uganda

Nadunget HCIII

Moroto, Karamoja, Uganda

Orum HCIV

Otuke, Lango, Uganda

Otwal HCIII

Oyam, Lango, Uganda