drugset / Trial / NCT03947437
Phase 1b/2a Trial to Evaluate LEP-F1 + GLA-SE in Healthy Adults and Leprosy Patients
Phase 1/2
Unknown
142 enrolled
The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
Oswaldo Cruz Institute · collab
RandomizedParallel-groupDouble-blindTreatment
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.
Timeline
- Start
- 2024-02
- Primary completion
- 2024-03
- Completion
- 2025-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | LEP-F1 | Protein / enzyme biologic | 2 ug | Intramuscular |
| Subject | LEP-F1 | Protein / enzyme biologic | 10 ug | Intramuscular |
| Background | GLA-SE | Other / unclassified | 5 ug | Intramuscular |