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New treatment option for Malaria Vaccines
Official title Infant Malaria Vaccine Schedule Optimization
ClinicalTrials.gov ID: NCT06879327
What this study is testing
What is R21 Matrix-M (R21/MM) Malaria Vaccine?
R21 Matrix-M (R21/MM) Malaria Vaccine is an investigational medicine, given as a monthly injection into a muscle, being studied as a potential treatment for malaria vaccines.
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
- The aim of this study is to identify an optimal infant vaccine schedule for a malaria vaccine which is better aligned with the timing of other vaccine interventions.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 42 to 49. Healthy volunteers may be eligible.
You may be able to join if
- Signed informed consent or thumb-printed and witnessed informed consent obtained from the parent/legal guardian of the infant.
- Infants must have been born full-term (at ≥37 weeks of gestation) and \> 2500 grams at birth.
- Immunization schedule Cohorts 1, 2, and 3: Male and female infants 42-49 days (inclusive) of age at time of enrollment.
- Prior to group randomization, for infants in Cohort 1 randomization to receive vaccine dose 1 (Groups 1 and 2 of R21/MM or placebo, respectively)...
- The participant's parent/guardian must be willing to avoid travel, particularly in the 28 days after each study vaccination, must confirm willingness...
You likely can't join if
- Acute disease at the time of enrolment (acute disease is defined as the presence of a moderate or severe illness with or without fever). This does...
- Clinically significant pulmonary, cardiovascular, gastrointestinal, endocrine, neurological, skin, hepatic or renal functional abnormality, as...
- At time of enrollment, any infant who has received any dose of the hexavalent/pentavalent vaccines, pneumococcal vaccine, rotavirus vaccine, IPV or...
- Weight-for-length/height Z score of less than -3 or other clinical signs of malnutrition.
- Infant with major congenital defects.
- The infant has anaemia associated with clinical signs of symptoms of decompensation, or a haemoglobin of ≤ 5.0 g/dL.
See the full eligibility criteria
- Signed informed consent or thumb-printed and witnessed informed consent obtained from the parent/legal guardian of the infant.
- Infants must have been born full-term (at ≥37 weeks of gestation) and \> 2500 grams at birth.
- Immunization schedule Cohorts 1, 2, and 3: Male and female infants 42-49 days (inclusive) of age at time of enrollment.
- Prior to group randomization, for infants in Cohort 1 randomization to receive vaccine dose 1 (Groups 1 and 2 of R21/MM or placebo, respectively) will occur at 42-49 days of age. Infants in Cohorts 2 and 3 will not be...
- The participant's parent/guardian must be willing to avoid travel, particularly in the 28 days after each study vaccination, must confirm willingness to contact the study team in the event of unexpected/unavoidable...
- The participant's parent/guardian must confirm willingness to bring their child to the study clinic / local health care clinic, and capacity to contact the study team in the event the subject has any illnesses or other...
- Participants who the investigator believes that their parent/guardian can and will comply with the requirements of the protocol (e.g. return for follow-up visits) may be enrolled in the study.
- Acute disease at the time of enrolment (acute disease is defined as the presence of a moderate or severe illness with or without fever). This does not include minor illnesses such as diarrhea, mild upper respiratory...
- Clinically significant pulmonary, cardiovascular, gastrointestinal, endocrine, neurological, skin, hepatic or renal functional abnormality, as determined by medical history, physical examination or laboratory tests...
- At time of enrollment, any infant who has received any dose of the hexavalent/pentavalent vaccines, pneumococcal vaccine, rotavirus vaccine, IPV or has received more than one dose of oral polio virus or more than one...
- Weight-for-length/height Z score of less than -3 or other clinical signs of malnutrition.
- Infant with major congenital defects.
- The infant has anaemia associated with clinical signs of symptoms of decompensation, or a haemoglobin of ≤ 5.0 g/dL.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
- Any confirmed or suspected immunosuppressive or immunodeficient state (including HIV or asplenia) or known maternal HIV infection (no HIV testing will be routinely done by the study team).
- Administration of immunoglobulins and/or any blood products/blood transfusion from birth to time of planned administration of the vaccine candidate.
- Previous vaccination of participant or biological mother with a malaria vaccine.
- Participation in another research study involving receipt of an investigational product or planned use during the study period.
- Any other findings that the investigator feels would increase the risk of having an adverse outcome from participation in the trial.
The study team makes the final eligibility decision.
Where it's taking place
- Bobo-Dioulasso, Burkina Faso
- Ouagadougou, Burkina Faso
Compensation & support
Compensation mentioned.
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, 42 days to 49 days. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bobo-Dioulasso, Burkina Faso; Ouagadougou, 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.