drugset / Trial / NCT01011309
A Study of the Efficacy and Safety of the LEISH-F2 + MPL-SE Vaccine for Treatment of Cutaneous Leishmaniasis
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to determine the efficacy, safety, and immunogenicity of an investigational vaccine being developed for the treatment of leishmaniasis, including cutaneous leishmaniasis (CL). The vaccine, identified as LEISH-F2 + MPL-SE, consists of a Leishmania protein (LEISH-F2) together with an adjuvant MPL-SE.
Timeline
- Start
- 2009-10
- Primary completion
- 2011-05
- Completion
- 2011-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | LEISH-F2 | Protein / enzyme biologic | 10 ug | — |
| Subject | MPL-SE | Other / unclassified | 25 ug | — |
| Comparator | sodium stibogluconate | Unknown | 20 mg/kg | Intravenous |