A Study to Test Experimental Blood Stage Malaria Vaccine in Burkina Faso.
ConditionMalaria,Falciparum
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age5-17
SponsorUniversity of Oxford
About this trial
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
Eligibility criteria
Qualifiers
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.
Disqualifiers
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 judged by the PI or other delegated individual.
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.
Trial design
Treatments tested in this trial
- Rabies vaccine
- RH5.1 10μg adjuvated with 50μg Matrix-M
- RH5.2 5μg adjuvated with 50μg Matrix-M
Treatment groups
480 Participants
are divided into 5 treatment groupsSponsors and collaborators
University of Oxford
Lead sponsor
Institut de Recherche en Sciences de la Sante, Burkina Faso
Collaborator
European and Developing Countries Clinical Trials Partnership (EDCTP)
Collaborator
Wellcome Trust
Collaborator
Source ClinicalTrials.gov