Clinical Trial

Trial LEP-F1 + GLA-SE in Healthy Adult in Areas Endemic for Leprosy

Not Yet Recruiting Phase 1
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Record status
This record was last updated October 4, 2024 (before its estimated March 2026 completion). Its status may not reflect the trial's current state.
Summary
This is a phase 1b, double-blind, randomized, placebo-controlled clinical trial to evaluate the safety, tolerability, and immunogenicity of LEP-F1 + GLA-SE compared to placebo administered as three intramuscular (IM) injections in adult participants aged 18 to 55.
Trial Details
NCT Number NCT06627257
Lead Sponsor The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
Collaborators: Oswaldo Cruz Institute
Conditions Leprosy
Enrollment 54 participants
Start Date 2025-01-02
Primary Completion 2026-03 (estimated)
Study Completion 2026-08 (estimated)
Updated on ClinicalTrials.gov 2024-10-04