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

This study has been completed.
Bill and Melinda Gates Foundation
Information provided by:
IDRI Identifier:
First received: May 20, 2005
Last updated: February 13, 2007
Last verified: February 2007
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.

Condition Intervention Phase
Leishmaniasis, Mucocutaneous
Biological: Leish-111f + MPL-SE vaccine
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalating Study to Evaluate Safety, Tolerability, and Immunogenicity of Leish-111f + MPL-SE Vaccine in Combination With Pentavalent Antimony in Treatment of Mucosal Leishmaniasis

Resource links provided by NLM:

Further study details as provided by IDRI:

Primary Outcome Measures:
  • Occurrence of dose-limiting toxicity
  • Adverse events

Secondary Outcome Measures:
  • IgG and T-cell response to Leish-111f vaccine
  • Leish-111f skin test reactivity
  • Safety of the vaccine with respect to the clinical course of mucosal leishmaniasis

Estimated Enrollment: 48
Study Start Date: July 2004
Estimated Study Completion Date: May 2006
Detailed Description:
Mucosal leishmaniasis is a disfiguring and possibly fatal infection. All available medical therapies require weeks of treatment and cause significant toxicity. In Peru, the standard therapy is daily intravenous (IV) pentavalent antimony (20 mg/kg/day) for 28 days. It appears that Leishmania infections can be eliminated by T helper 1 immune responses. These findings argue that a vaccine that augments mucosal leishmaniasis patients’ T helper 1 responses will eliminate the infection and disease. This study is a phase 1, randomized, double-blind, placebo controlled, sequential dose-escalating trial to evaluate the safety and immunogenicity of three injections of 5, 10, or 20 μg of Leish-111f protein + 25 μg of MPL-SE adjuvant given at 4 week intervals as an adjunct to standard chemotherapy with pentavalent antimony (20 mg/kg/day for 28 days) in patients with mucosal leishmaniasis.

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with mucosal leishmaniasis confirmed by a positive smear, in vitro culture or PCR test

Exclusion Criteria:

  • Mucosal leishmaniasis must not involve the vocal cords or cause respiratory distress, and there must be no evidence of other disease.
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Please refer to this study by its identifier: NCT00111514

Clínica de Leishmaniasis, Hospital Nacional Sur Este EsSalud
Cusco, Peru
Universidad Peruana Cayetano Heredia
Lima, Peru, 100
Sponsors and Collaborators
Bill and Melinda Gates Foundation
Principal Investigator: Alejandro Llanos-Cuentas, MD Universidad Peruana Cayetano Heredia
Study Director: Franco M Piazza, MD, MPh IDRI
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00111514     History of Changes
Other Study ID Numbers: IDRI-LMVTC-102
Study First Received: May 20, 2005
Last Updated: February 13, 2007

Keywords provided by IDRI:
Subunit vaccine
pentavalent antimony

Additional relevant MeSH terms:
Leishmaniasis, Mucocutaneous
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases
Leishmaniasis, Cutaneous
Immunologic Factors
Physiological Effects of Drugs processed this record on April 26, 2017