CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 45 enrolled
Drug / intervention
LEISH-F2 + MPL-SE +1 morebiological
Likely dose
LEISH-F2 + MPL-SE 10 μgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01011309
NCT01011309Phase 2Completed
CompareCT.gov

A Phase 2, Randomized, Open-Label, Controlled Study to Evaluate the Efficacy, Safety, and Immunogenicity of the LEISH-F2 + MPL-SE Vaccine in the Treatment of Patients With Cutaneous Leishmaniasis

Access to Advanced Health Institute (AAHI)·interventional·Posted Nov 11, 2009·Updated Dec 11, 2013

In Brief

A Phase 2 clinical trial evaluating LEISH-F2 + MPL-SE and Sodium stibogluconate for Cutaneous Leishmaniasis. Completed, enrolled 45 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCutaneous Leishmaniasis
CountriesPeru
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 11, 2009
Enrollment StartOct 1, 2009
Primary CompletionMay 1, 2011
Study CompletionDec 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 16.6 years ago

Interventions

LEISH-F2 + MPL-SEbiological

10 μg LEISH-F2 + 25 μg MPL-SE on Days 0, 28 and 56

Sodium stibogluconatedrug

20 mg/kg/day IV daily for 20 days