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

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: May 23, 2005
Last Update Posted: February 15, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Bill and Melinda Gates Foundation
Information provided by:
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
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.

Information from the National Library of Medicine

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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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00111514     History of Changes
Other Study ID Numbers: IDRI-LMVTC-102
First Submitted: May 20, 2005
First Posted: May 23, 2005
Last Update Posted: February 15, 2007
Last Verified: February 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