Actively Recruiting
A Study to Test Experimental Blood Stage Malaria Vaccine in Burkina Faso.
Led by University of Oxford · Updated on 2025-03-07
480
Participants Needed
1
Research Sites
164 weeks
Total Duration
On this page
Sponsors
U
University of Oxford
Lead Sponsor
I
Institut de Recherche en Sciences de la Sante, Burkina Faso
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
A Study to Test Experimental Blood Stage Malaria Vaccine in Burkina Faso.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy infant aged 5-17 months at the time of first study vaccination
- Parent or guardian provides signed or thumb-printed informed consent
- Infant and parent or guardian live in the study area and can be available for vaccination and follow-up for 12 months after the last vaccine dose
You will not qualify if you...
- Clinically significant congenital abnormalities as judged by the investigator
- Clinically significant skin, cardiovascular, respiratory, endocrine, liver, renal, gastrointestinal, or neurological disorders as judged by the investigator
- Weight-for-age Z score less than -3 or signs of malnutrition
- History of allergic reaction, significant IgE-mediated event, or anaphylaxis to immunization
- History of allergic disease or reactions likely worsened by vaccine components
- Sickle cell disease
- Significant laboratory abnormalities as judged by the study clinician
- Received immunoglobulins or blood products within 3 months before planned vaccination
- Received any vaccine within 7 days before enrollment or planned receipt of any vaccine within 7 days after each study vaccination
- Previous vaccination with another malaria vaccine
- Participation in another investigational product study within 30 days before enrollment or planned during the study
- Known maternal HIV infection
- Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection, asplenia, severe infections, or immunosuppressive medication use within past 6 months (except inhaled or topical steroids)
- Any significant disease or condition that may increase risk or affect study results or participation as judged by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Institut de Recherche en Sciences de la Santé
Siglé, Boulkiemdé Province, Burkina Faso, BP 7192 OUAGADOUGOU 03, BF
Actively Recruiting
Research Team
J
Jee-Sun Cho
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
5
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