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

NCT01011309 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2013-12-11

Study results available
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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.

Conditions

  • Cutaneous Leishmaniasis

Interventions

BIOLOGICAL

LEISH-F2 + MPL-SE

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

DRUG

Sodium stibogluconate

20 mg/kg/day IV daily for 20 days

Sponsors & Collaborators

  • Access to Advanced Health Institute (AAHI)

    lead OTHER

Principal Investigators

  • Franco Piazza, MD, MPH · Access to Advanced Health Institute (AAHI)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2011-05-31
Completion
2011-12-31

Countries

  • Peru

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01011309 on ClinicalTrials.gov