Clinical Trial

L9LS-R21 Interaction

Withdrawn Phase 2
View on ClinicalTrials.gov →
Why the trial stopped
After careful review of R21 interaction data that recently became available from a previous L9LS infant study, the study team has made the decision to not move forward with this protocol.
Summary
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.
Protocol Amendment History 2 changes
critical Trial status changed: Not Yet Recruiting → Withdrawn 2026-04-10
notable Enrollment reduced: 357 -> 0 participants 2026-04-10
Trial Details
NCT Number NCT07208760
Lead Sponsor National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators: National Institutes of Health (NIH), Malaria Research and Training Center, Bamako, Mali, Faculté de Médecine Pharmacie d'Odontostomatologie (FMOS), University of Sciences, Techniques, and Technologies of Bamako (USTTB), University of Washington, Indiana University
Conditions Malaria
Start Date 2026-03
Primary Completion 2028-03 (estimated)
Study Completion 2029-03 (estimated)
Updated on ClinicalTrials.gov 2026-04-09