Trials Sponsors Conditions Drugs Pricing

Conditions

Malaria PLASMODIUM FALCIPARUM MALARIA

Keywords

R21/Matrix-MMalaria vaccineVaccine effectivenessTest-negative designClinical malariaChildrenBurkina FasoUganda

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

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

Biological: R21/Matris-M Malaria vaccine

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

Biological: R21/Matris-M Malaria vaccine

Interventions

R21/Matris-M Malaria vaccineBiological

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.

Suspected malaria cases that test negative using microscopySuspected malaria cases that test positive using microscopy

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age5 Months - 5 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

Sampling MethodNon-Probability Sample

Study Population

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:

Sponsors & Collaborators

University of California, San Francisco
Othercollaborator
Ministry of Health, Burkina Faso
Governmentcollaborator
Ministry of Health, Uganda

Study Sites (21)

Boromo urbain 1

Boromo, Boucle Mouhoun, Burkina Faso

RECRUITING

Halidou Tinto, PhDCONTACT+226 25 40 92 12 tintoh@crun.bf

Ouahabou

Boromo, Boucle Mouhoun, Burkina Faso

RECRUITING

h Tinto, PhDCONTACT+226 25 40 92 12 tintoh@crun.bf

Biospecimen

Retention: SAMPLES WITH DNA

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

MalariaMalaria, Falciparum

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Study Officials

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
PRINCIPAL INVESTIGATOR

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

Actual (reported)

Primary Completion

June 2027

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (2)

Suspected malaria cases that test positive using microscopy

Suspected malaria cases that test negative using microscopy

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (21)

Biospecimen

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (2)

Suspected malaria cases that test positive using microscopy

Suspected malaria cases that test negative using microscopy

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (21)

Biospecimen

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations