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NOT YET RECRUITING
NCT06627257
PHASE1

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

Sponsor: The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)

View on ClinicalTrials.gov

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.

Official title: A Phase 1b, Double-Blind, Randomized, Placebo-Controlled, Antigen Dose-Escalation Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of LEP-F1 + GLA-SE in Healthy Adult Participants in Areas Endemic for Leprosy

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

54

Start Date

2025-01-02

Completion Date

2026-08

Last Updated

2024-10-04

Healthy Volunteers

Yes

Conditions

Interventions

DRUG

LepVax (2 μg LEP-F1 + 5 μg GLA-S): Low dose

2 μg LEP-F1 + 5 μg GLA-SE will be administered by IM injection on Days 0,28, and 56 in healthy participants.

DRUG

LepVax (10 μg LEP-F1 + 5 μg GLA-SE): High dose

10 μg LEP-F1 + 5 μg GLA-SE will be administered by IM injection on Days 0,28, and 56 in healthy participants.

OTHER

Placebo Comparator: Placebo

Sterile normal saline for injection will be administered by IM injection on Days 0, 28, and 56 in healthy participants and paucibacillary leprosy patients.

Locations (1)

Oswaldo Cruz Institue

Rio de Janeiro, Rio de Janeiro, Brazil