drugset / Trial / NCT00486382
Open-Label Safety Study of Three-Antigen Leishmania Polyprotein With Adjuvant MPL-SE in Healthy Adults in India
Phase 1
Completed
36 enrolled
Access to Advanced Health Institute (AAHI)
Bill and Melinda Gates Foundation · collab
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to determine if a vaccine (called Leish-111f + MPL-SE) is safe and whether it can or cannot produce a protective response against visceral leishmaniasis when injected to healthy subjects.
Timeline
- Start
- 2007-04
- Primary completion
- 2008-11
- Completion
- 2008-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Leish-111f | Protein / enzyme biologic | 5 ug | Subcutaneous |
| Subject | Leish-111f | Protein / enzyme biologic | 10 ug | Subcutaneous |
| Subject | Leish-111f | Protein / enzyme biologic | 20 ug | Subcutaneous |
| Background | MPL-SE | Other / unclassified | 25 ug | Subcutaneous |