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New treatment option for Malaria,Falciparum
Official title A Study to Test Experimental Blood Stage Malaria Vaccine in Burkina Faso.
ClinicalTrials.gov ID: NCT05790889
What this study is testing
What is Rabies vaccine?
Rabies vaccine is an investigational medicine, being studied as a potential treatment for malaria,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 is a Phase IIb randomised controlled trial of the safety, immunogenicity and efficacy of the blood-stage malaria vaccine candidates RH5.1 in Matrix-MTM and RH5.2-VLP in Matrix-MTM in infants aged 5-17 months in Burkina Faso
- 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 5 to 17. Healthy volunteers may be eligible.
You may be able to join if
- Healthy infant aged 5-17 months at the time of first study vaccination
- Parent/guardian provides signed/thumb-printed informed consent
- Infant and parent/guardian resident in the study area villages and anticipated to be available for vaccination and follow-up for 12 months following...
You likely can't join if
- Clinically significant congenital abnormalities as judged by the PI or other delegated individual.
- Clinically significant skin disorder (psoriasis, contact dermatitis etc.), cardiovascular disease, respiratory disease, endocrine disorder, liver...
- Weight-for-age Z score of less than -3 or other clinical signs of malnutrition.
- History of allergic reaction, significant IgE-mediated event, or anaphylaxis to immunization.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
- Sickle cell disease.
See the full eligibility criteria
- Healthy infant aged 5-17 months at the time of first study vaccination
- Parent/guardian provides signed/thumb-printed informed consent
- Infant and parent/guardian resident in the study area villages and anticipated to be available for vaccination and follow-up for 12 months following last dose of vaccination.
- Clinically significant congenital abnormalities as judged by the PI or other delegated individual.
- Clinically significant skin disorder (psoriasis, contact dermatitis etc.), cardiovascular disease, respiratory disease, endocrine disorder, liver disease, renal disease, gastrointestinal disease, neurological illness as...
- Weight-for-age Z score of less than -3 or other clinical signs of malnutrition.
- History of allergic reaction, significant IgE-mediated event, or anaphylaxis to immunization.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
- Sickle cell disease.
- Clinically significant laboratory abnormality as judged by the study clinician.
- Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate.
- Receipt of any vaccine in the 7 days preceding enrolment, or planned receipt of any other vaccine within 7 days following each study vaccination.
- History of vaccination with another malaria vaccine.
- Participation in another research study involving receipt of an investigational product in the 30 days preceding enrolment, or planned use during the study period.
- Known maternal HIV infection (no testing will be done by the study team).
- Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent, severe infections and chronic (more than 14 days) immunosuppressant medication within the past 6...
- 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 trial, or the...
The study team makes the final eligibility decision.
Where it's taking place
- Siglé, Boulkiemdé Province, Burkina Faso
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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, 5 months to 17 months. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Siglé, Boulkiemdé Province, 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.