This is a Phase Ib age de-escalation, dose escalation, open-label study to assess the safety and immunogenicity of the multi-stage malaria vaccine candidate R21 plus RH5.1 and/or R78C in Matrix-M in adults aged 18-35 years and children aged 5-17 months in Burkina Faso.
Group 1: Healthy adult aged 18-35 years at the time of first study vaccination
Group 2-6: Healthy child aged 5-17 months at the time of first study vaccination
Group 1: Female participants must be non-pregnant (as demonstrated by a negative urine pregnancy .
Participant or parent/guardian provides signed/thumb-printed informed consent
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.
History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ).
Children with weight-for-age Z score of less than -3 or other clinical signs of malnutrition.
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Treatment groupsSee each treatment group below.
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
European Vaccine Initiative
Collaborator
Bundesministerium für Forschung, Technologie und Raumfahrt (BMFTR)
Collaborator