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A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Effect of L9LS on R21/Matrix-M™ Vaccine Immunogenicity
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.
Details
| Lead sponsor | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Phase | Phase 2 |
| Status | WITHDRAWN |
| Start date | 2026-03 |
| Completion | 2029-03 |
Conditions
- Malaria
Interventions
- Single dose of 1800 mg L9LS SC (12mL)
- Placebo 12 mL SC
- Single dose of 225 mg L9LS SC (1.5mL)
- Placebo 1.5 mL SC
Primary outcomes
- Part 1: Incidence and severity of hypersensitivity reactions — Occurring within 7 days after the administration of the first dose of the R21/Matrix-M™ vaccine.
- Part 2: Total IgG anti-NANP antibody titers — 28 days after the third R21/Matrix-M™ vaccination
Measured by ECLIA, using the Meso Scale Discovery (MSD) LLC-based automation platform
Countries
Mali