Assessing Vaccine Effectiveness of R21/Matrix-M Across Malaria Transmission Settings (AVERT)
AVERT
Real-World Effectiveness of the R21/Matrix-M Malaria Vaccine in Children in Burkina Faso and Uganda
3 other identifiers
observational
20,000
2 countries
21
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2026
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 14, 2026
CompletedFirst Submitted
Initial submission to the registry
August 3, 2026
CompletedFirst Posted
Study publicly available on registry
August 6, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2027
August 6, 2026
August 1, 2026
11 months
August 3, 2026
August 3, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Dose-specific effectiveness of R21/Matrix-M against microscopy-confirmed clinical malaria
Adjusted vaccine effectiveness will be calculated as (1 - adjusted odds ratio) x 100%. The odds ratio will compare the odds of each documented R21/Matrix-M dose category among microscopy-positive malaria cases with the odds among microscopy-negative controls, using children with 0 doses as the primary reference group. Prespecified grouped dose categories will be used if individual dose categories do not have adequate statistical power.
At the enrollment illness episode, during the approximately 7- to 8-month study recruitment period
Secondary Outcomes (6)
Effectiveness of R21/Matrix-M by time since vaccination
At the enrollment illness episode, during the approximately 7- to 8-month recruitment period
Effect modification of vaccine effectiveness by malaria transmission intensity
At the enrollment illness episode, during the approximately 7- to 8-month recruitment period
Effect modification of vaccine effectiveness by sex
At the enrollment illness episode, during the approximately 7- to 8-month recruitment period
Effect modification by other malaria prevention interventions
At the enrollment illness episode, during the approximately 7- to 8-month recruitment period
Effectiveness according to vaccine dose timing
At the enrollment illness episode, during the approximately 7- to 8-month recruitment period
- +1 more secondary outcomes
Study Arms (2)
Suspected malaria cases that test positive using microscopy
Eligible children with suspected malaria whose enrollment blood smear microscopy result is positive for P. falciparum infection
Suspected malaria cases that test negative using microscopy
Eligible children with suspected malaria whose enrollment blood smear microscopy result is negative for P. falciparum infection
Interventions
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.
Eligibility Criteria
Children younger than 5 years who reside in the catchment areas of selected health facilities in R21/Matrix-M implementation districts in Burkina Faso or Uganda, are age-eligible for vaccination under the relevant national schedule, and present for outpatient care with suspected malaria. Participants are recruited from health facilities in moderate- to high-transmission settings.
You may qualify if:
- 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.
You may not qualify if:
- Caregiver is unable or unwilling to provide informed consent.
- Severe non-malaria illness at presentation that would interfere with study participation.
- Documented receipt of any RTS,S malaria vaccine dose.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Clinton Health Access Initiative Inc.lead
- University of California, San Franciscocollaborator
- Infectious Diseases Research Collaboration, Ugandacollaborator
- Institut de Recherche en Sciences de la Sante, Burkina Fasocollaborator
- Ministry of Health, Burkina Fasocollaborator
- Ministry of Health, Ugandacollaborator
Study Sites (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
Biospecimen
Finger-prick dried blood spots, blood smears, and used positive malaria rapid diagnostic tests will be collected. Blood smears will confirm case or control status, and specimens may undergo serology. Malaria-positive specimens may undergo parasite genotyping. Samples may be stored for future ethically approved research where separate consent and local approvals permit.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Isabel Rodriguez-Barraquer, MD, PhD
University of California, San Francisco
- PRINCIPAL INVESTIGATOR
Halidou Tinto, PhD
Institut de Recherche en Sciences de la Santé (Burkina Faso)
- PRINCIPAL INVESTIGATOR
Joaniter Nankabirwa, MD, PhD
Infectious Diseases Research Collaboration, Kampala, Uganda
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 3, 2026
First Posted
August 6, 2026
Study Start
July 14, 2026
Primary Completion (Estimated)
June 1, 2027
Study Completion (Estimated)
August 1, 2027
Last Updated
August 6, 2026
Record last verified: 2026-08