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

PHASE1Not yet recruitingINTERVENTIONAL
Enrollment

54

Participants

Timeline

Start Date

January 2, 2025

Primary Completion Date

March 31, 2026

Study Completion Date

August 31, 2026

Conditions
Leprosy
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.

Trial Locations (1)

21040-360

Oswaldo Cruz Institue, Rio de Janeiro

All Listed Sponsors
collaborator

Oswaldo Cruz Institute

UNKNOWN

lead

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

OTHER