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

NCT07749911 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 20000

Last updated 2026-08-06

No results posted yet for this study

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.

Conditions

  • Malaria
  • PLASMODIUM FALCIPARUM MALARIA

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.

Sponsors & Collaborators

  • University of California, San Francisco

    collaborator OTHER

  • Infectious Diseases Research Collaboration, Uganda

    collaborator OTHER

  • Institut de Recherche en Sciences de la Sante, Burkina Faso

    collaborator OTHER_GOV

  • Ministry of Health, Burkina Faso

    collaborator OTHER_GOV

  • Ministry of Health, Uganda

    collaborator OTHER_GOV

  • Clinton Health Access Initiative Inc.

    lead OTHER

Principal Investigators

  • Isabel Rodriguez-Barraquer, MD, PhD · University of California, San Francisco

  • Halidou Tinto, PhD · Institut de Recherche en Sciences de la Santé (Burkina Faso)

  • Joaniter Nankabirwa, MD, PhD · Infectious Diseases Research Collaboration, Kampala, Uganda

Eligibility

Min Age
5 Months
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-14
Primary Completion
2027-06-30
Completion
2027-08-31

Countries

  • Burkina Faso
  • Uganda

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07749911 on ClinicalTrials.gov