drugset / Trial / NCT03302897
Phase 1 LEP-F1 + GLA-SE Vaccine Trial in Healthy Adult Volunteers
Phase 1
Completed
24 enrolled
Access to Advanced Health Institute (AAHI)
American Leprosy Missions · collab
Non-randomizedParallel-groupOpen-labelPrevention
Summary
The purpose of this study is to compare the safety, tolerability, and immunogenicity in healthy adult subjects of an investigational vaccine being developed for the prevention of leprosy. Two dose levels of the vaccine will be evaluated.
Timeline
- Start
- 2017-10-02
- Primary completion
- 2019-03-05
- Completion
- 2019-03-05
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 |