drugset
drugset / Trial / NCT07208760

L9LS-R21 Interaction

NCT07208760 ↗

Phase 2 Withdrawn National Institute of Allergy and Infectious Diseases (NIAID) Faculté de Médecine Pharmacie d'Odontostomatologie (FMOS) · collabIndiana University · collabMalaria Research and Training Center, Bamako, Mali · collabNational Institutes of Health (NIH) · collabUniversity of Sciences, Techniques, and Technologies of Bamako (USTTB) · collabUniversity of Washington · collab
Non-randomizedSequentialTriple-blindPrevention

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.

Timeline

Start
2026-03
Primary completion
2028-03
Completion
2029-03

Outcome

Outcome not reported

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.”

Drugs

EvaluationDrugModalityDoseRoute
Subject L9LS Monoclonal antibody 225 mg Subcutaneous
Subject L9LS Monoclonal antibody 1800 mg Subcutaneous

Indications

malaria