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Phase 1b/2a Trial to Evaluate LEP-F1 + GLA-SE in Healthy Adults and Leprosy Patients

NCT03947437 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 142

Last updated 2023-06-13

No results posted yet for this study

Summary

This is a phase 1b/2a, double-blind, randomized, placebo-controlled clinical trial to evaluate the safety, tolerability, and immunogenicity of the LEP-F1 + GLA-SE investigational vaccine compared to placebo.

Conditions

  • Leprosy

Interventions

BIOLOGICAL

LEP-F1 + GLA-SE

Leprosy antigen formulated with an adjuvant.

BIOLOGICAL

Placebo

Sterile normal saline for injection.

Sponsors & Collaborators

  • Oswaldo Cruz Institute

    collaborator UNKNOWN

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

    lead OTHER

Principal Investigators

  • Veronica Schmitz Pereira, PHD · Instituto Oswaldo Cruz

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-02-29
Primary Completion
2024-03-31
Completion
2025-04-30
FDA Drug
Yes

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03947437 on ClinicalTrials.gov