R21/Matrix-M malaria vaccine: effectiveness and safety in children

A Case Control Study to Assess Effectiveness and Safety of The R21/Matrix-M Malaria Vaccine

This project will try to see if the R21/Matrix‑M vaccine lowers severe and clinical P. falciparum malaria in children and whether vaccinated children have a different risk of death.

Quick facts

• Study type: Observational
• Enrollment: 2308 (estimated)
• Ages: 5 Months and up
• Sex: All
• Sponsor: Serum Institute of India Pvt. Ltd. (industry)
• Locations: 5 sites (Bousse, Burkina Faso and 4 other locations)
• Trial ID: NCT07009847 on ClinicalTrials.gov

What this trial studies

This observational case–control project enrolls children who meet case definitions for severe P. falciparum malaria, clinical malaria in high‑transmission perennial areas, or death (all causes) and compares their prior R21/Matrix‑M vaccination status to matched community controls. For severe malaria and death cases, four age‑ and neighborhood‑matched controls per case will be enrolled; clinical malaria cases in high‑transmission areas will have a 1:1 matched control. Cases are identified at hospitals, clinics, or community sites and vaccination and medical records are reviewed after parental or guardian consent. The study is conducted at multiple centers where R21/Matrix‑M has been deployed to estimate real‑world effectiveness and monitor all‑cause mortality.

Who should consider this trial

Good fit: Children who were eligible to receive R21/Matrix‑M by age, live in the vaccine implementation areas, and whose parent or guardian can provide informed consent and access to vaccination and medical records.

Not a fit: Children who live outside participating vaccine deployment areas, are outside the eligible age range, or lack verifiable vaccination or medical records are unlikely to be included or to gain direct benefit from this study.

Why it matters

Potential benefit: If successful, the results could show that R21/Matrix‑M reduces severe and clinical falciparum malaria in children and provide reassurance about its safety with respect to all‑cause deaths.

How similar studies have performed: Randomized trials of R21/Matrix‑M have shown promising protection against clinical P. falciparum malaria in children, but real‑world effectiveness and effects on mortality remain less well characterized.

Eligibility criteria

Inclusion Criteria:

For Cases- A male or female child eligible to have received R21/Matrix-M Vaccine based on age. 2 Parent/legal guardian/ caregiver of the child willing to provide the written informed consent for their child's participation in the study.

3 Parent/legal guardian/ caregiver willing to comply with the study requirements and share or allow access to the data regarding the vaccination status and medical records with the study personnel.

4 Resident of the R21/Matrix-M vaccine implementation area and brought to the study hospital /clinic or sub-site with clinical complaints. 5 Child meeting the respective case definition (Severe Malaria, Clinical Malaria or Death due to any cause).

For Controls- A male or female child eligible to have received R21/Matrix-M Vaccine based on age. The matched control should have a date of birth within 60 days of that of the case.

2\. Parent/legal guardian/ caregiver of the child willing to provide the informed consent for their child's participation in the study.

3\. Parent/ legal guardian/ caregiver willing to comply with the study requirements and share or allow access to the data regarding the vaccination status and medical records with the study personnel 4. Resident of the R21/Matrix-M vaccine implementation area and who would have sought treatment at the same hospital if they had developed symptoms. Resident will be defined as child and/or child's parents/ guardian/caregiver eating and sleeping in a household in the location for most days of the week from past 6 months. The matched control should be residing in the same neighborhood as the respective case, but not from the same household.

Exclusion Criteria:

For Cases-

1. Parent/legal guardian/ caregiver not consenting to let the child participate or not permitting to access the data related to vaccination or other medical records.
2. Child not meeting the respective case definition (Severe Malaria, Clinical Malaria or Death due to any cause).
3. Received one or more doses of RTS,S/AS01 vaccine in the past.

For Controls-

1. Parent/legal guardian/ caregiver not consenting to let the child participate or not permitting to access the data related to vaccination or other medical records.
2. Child meeting any of the case definitions (Severe Malaria, Clinical Malaria).
3. Child having history suggestive of clinical malaria in past 30 days (applicable for clinical malaria and severe malaria case-control studies only).
4. Received one or more doses of RTS,S/AS01 vaccine/s in the past.

Where this trial is running

Bousse, Burkina Faso and 4 other locations

• Unité de Recherche Clinique de Nanoro (URCN), Institut de Recherche en Sciences de la Santé, Direction Régionale du Centre-Ouest (IRSS-DRCO), Bousse — Bousse, Burkina Faso, Burkina Faso (RECRUITING)
• Centre de Recherche et de Lutte contre le Paludisme Institut National de Santé Publique, boulevard Nangui Abrogoua près État Major des Armées — Toumodi, Côte d’Ivoire (RECRUITING)
• University of Ilorin Department of Pediatrics University of Ilorin Teaching Hospital, Ilorin, Nigeria — Yenagoa, Bayesla, Nigeria (RECRUITING)
• Infectious Diseases Research Collaboration (IDRC), Uganda — Busia, Uganda, Uganda (RECRUITING)
• Makerere University College of Health Sciences — Mukono, Uganda (RECRUITING)

Study contacts

• Study coordinator: Dr. Prasad Kulkarni, MD, FRCP

Conditions: Malaria,Falciparum, Morality, clinical malaria, severe malaria, death