drugset / Trial / NCT01011309

A Study of the Efficacy and Safety of the LEISH-F2 + MPL-SE Vaccine for Treatment of Cutaneous Leishmaniasis

NCT01011309

Phase 2 Completed 45 enrolled Access to Advanced Health Institute (AAHI)
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

EvaluationDrugModalityDoseRoute
Subject LEISH-F2 Protein / enzyme biologic 10 ug
Subject MPL-SE Other / unclassified 25 ug
Comparator sodium stibogluconate Unknown 20 mg/kg Intravenous