drugset / Trial / NCT07208760
L9LS-R21 Interaction
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Withdrawn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
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | L9LS | Monoclonal antibody | 225 mg | Subcutaneous |
| Subject | L9LS | Monoclonal antibody | 1800 mg | Subcutaneous |