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Study to Evaluate the Leish-111F + MPL-SE Vaccine in the Treatment of Mucosal Leishmaniasis

NCT00111514 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2007-02-15

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety of the Leish-111f + MPL-SE vaccine given as three injections every 28 days at each of three dose levels of Leish-111f protein, in combination with standard pentavalent antimony therapy in adult patients with mucosal leishmaniasis.

Conditions

  • Leishmaniasis, Mucocutaneous

Interventions

BIOLOGICAL

Leish-111f + MPL-SE vaccine

Sponsors & Collaborators

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • Access to Advanced Health Institute (AAHI)

    lead OTHER

Principal Investigators

  • Alejandro Llanos-Cuentas, MD · Universidad Peruana Cayetano Heredia

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2004-07-31
Completion
2006-05-31

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 NCT00111514 on ClinicalTrials.gov