This is a randomized, double-blind, placebo-controlled trial in 2 parts evaluating the effect of 1-time administration of the monoclonal antibody (MAb) L9LS to healthy Malian participants on the immunogenicity of subsequent administration of the R21/Matrix-M vaccine. L9LS will be administered subcutaneously (SC) for adults and infants. The study will assess how the timing of L9LS administration impacts immunogenicity following subsequent intramuscular (IM) R21/Matrix-M vaccination. Twenty-four adult participants and 333 infant participants will be enrolled.
Phase:
PHASE2
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators:
Facult de Mdecine Pharmacie d'Odontostomatologie (FMOS) Indiana University School of Medicine, Indiana University Malaria Research and Training Center (MRTC) National Institutes of Health (NIH) University of Sciences, Techniques, and Technologies of Bamako (USTTB) University of Washington