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

May 20, 2005
February 13, 2007
July 2004
Not Provided
  • Occurrence of dose-limiting toxicity
  • Adverse events
Same as current
Complete list of historical versions of study NCT00111514 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Study to Evaluate the Leish-111F + MPL-SE Vaccine in the Treatment of Mucosal Leishmaniasis
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

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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Leishmaniasis, Mucocutaneous
Biological: Leish-111f + MPL-SE vaccine
Not Provided
Llanos-Cuentas A, Calderón W, Cruz M, Ashman JA, Alves FP, Coler RN, Bogatzki LY, Bertholet S, Laughlin EM, Kahn SJ, Beckmann AM, Cowgill KD, Reed SG, Piazza FM. A clinical trial to evaluate the safety and immunogenicity of the LEISH-F1+MPL-SE vaccine when used in combination with sodium stibogluconate for the treatment of mucosal leishmaniasis. Vaccine. 2010 Oct 28;28(46):7427-35. Epub 2010 Sep 17.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
May 2006
Not Provided

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.
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Peru
 
NCT00111514
IDRI-LMVTC-102
Not Provided
Not Provided
Infectious Disease Research Institute
Bill and Melinda Gates Foundation
Principal Investigator: Alejandro Llanos-Cuentas, MD Universidad Peruana Cayetano Heredia
Study Director: Franco M Piazza, MD, MPh Infectious Disease Research Institute
Infectious Disease Research Institute
February 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP