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

This study has been completed.
Sponsor:
Collaborator:
Bill and Melinda Gates Foundation
Information provided by:
Infectious Disease Research Institute
ClinicalTrials.gov Identifier:
NCT00111514
First received: May 20, 2005
Last updated: February 13, 2007
Last verified: February 2007
  Purpose

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
Endpoint Classification: Safety Study
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 Infectious Disease Research Institute:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00111514

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

No publications provided by Infectious Disease Research Institute

Additional 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
Study First Received: May 20, 2005
Last Updated: February 13, 2007
Health Authority: Peru: General Directorate of Pharmaceuticals, Devices, and Drugs
United States: Food and Drug Administration

Keywords provided by Infectious Disease Research Institute:
Leishmaniasis
Subunit vaccine
therapeutic
T-cell
pentavalent antimony

Additional relevant MeSH terms:
Leishmaniasis
Leishmaniasis, Mucocutaneous
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases
Leishmaniasis, Cutaneous

ClinicalTrials.gov processed this record on July 20, 2014