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New treatment option for Malaria (Plasmodium Falciparum)
Official title Dose Finding Trial of R21/Matrix-M in School Children
ClinicalTrials.gov ID: NCT07074665
What this study is testing
What is 5µg R21/50µg Matrix-M?
5µg R21/50µg Matrix-M is an investigational medicine, being studied as a potential treatment for malaria (plasmodium falciparum).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 8. Healthy volunteers may be eligible.
You may be able to join if
- 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.
You likely can't join if
- 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...
See the full eligibility 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.
- 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...
- 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...
- 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.
- The child is currently participating in another clinical trial if likely to affect data interpretation of this trial.
- The child has any significant disease, disorder or situation which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the...
The study team makes the final eligibility decision.
Where it's taking place
- Nanoro, Burkina Faso
Compensation & support
Compensation likely.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 years to 8 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nanoro, Burkina Faso. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.