Loading clinical trials...

Dose Finding Trial of R21/Matrix-M in School Children | Clinical Trials | Clareo Health

RECRUITINGPHASE2

Dose Finding Trial of R21/Matrix-M in School Children

A Phase II Randomised Trial to Evaluate the Safety and Immunogenicity of a R21/Matrix-M Booster Vaccine at Two Different Doses in Burkinabe School Children

NCT07074665•University of Oxford

View on ClinicalTrials.gov

Summary

This trial is a double-blind, randomised, trial recruiting participants from the R21 phase IIb trial (VAC 076) which took place between May 2019 and July 2023 in Nanoro, Burkina Faso. Participants (n=30-40) who have previously received four doses of the 5µg R21/50µg Matrix-M malaria vaccine in VAC 076 will be randomised to receive either 5µg R21/50µg Matrix-M or 10µg R21/50µg Matrix-M. Safety and immunogenicity of a booster at school age at these two different doses will be assessed. Participants will be followed up for one year after the booster.

Eligibility

Age

6 - 8 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•The child received four doses of R21/Matrix-M in the phase IIb study evaluating R21/MatrixM in Nanoro, Burkina Faso (VAC 076).
•Signed informed consent/thumb-printed and witnessed informed consent obtained from the parent(s)/guardian(s) of the child to join the trial.
•The investigator believes that the parents/guardians can and will comply with the requirements of the protocol if the child is enrolled in the study.
•The child is a permanent resident of the study area and is expected to remain a resident for the duration of the trial.

Exclusion Criteria

•The child is enrolled in another malaria vaccine trial.
•The child has a history of allergic disease or reactions likely to be exacerbated by any component of the malaria vaccine.
•The child has a history of allergic reactions, significant IgE-mediated events or anaphylaxis to previous immunisations.
•The child has major congenital defects.
•The child has anaemia associated with clinical signs of symptoms of decompensation, or a haemoglobin of ≤ 5.0 g/dL.
•The child has been administered immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate.
•The child has malnutrition requiring hospital admission.
•The child has an acute or chronic, clinically significant pulmonary, cardiovascular, gastrointestinal, endocrine, neurological, skin, hepatic or renal functional abnormality, as determined by medical history, physical examination or laboratory tests.
•Children currently meeting the WHO criteria for HIV disease of stage 3 or 4 severity. A previous history of stage 3 or 4 disease is not an exclusion. Note: There will be no routine testing for HIV. Positive diagnoses will be recorded at screening if known.
•The child has received an investigational drug or investigational vaccine other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
+2 more criteria

Locations (1)

Unité de Recherche Clinique de Nanoro (URCN)

Nanoro, Burkina Faso

Key Dates

Start Date

February 18, 2026

Primary Completion Date

April 1, 2026

Completion Date

March 1, 2027

Last Updated

February 23, 2026

Enrollment

ESTIMATED participants

Conditions

Malaria (Plasmodium Falciparum)

Interventions

5µg R21/50µg Matrix-M

BIOLOGICAL

10µg R21/50µg Matrix-M

BIOLOGICAL

Contacts

Mehreen Datoo

CONTACT

+44 7859035715 mehreen.datoo@ndm.ox.ac.uk

Field Trial of PfSPZ-LARC2 Vaccine in Burkinabe Adults

NCT07385287

Malaria (Plasmodium Falciparum)

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 23, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions