Back to resultsStudy to Evaluate the Leish-111F + MPL-SE Vaccine in the Treatment of Mucosal Leishmaniasis
Primary Purpose
Leishmaniasis, Mucocutaneous
Status
Completed
Phase
Phase 1
Locations
Peru
Study Type
Interventional
Intervention
Leish-111f + MPL-SE vaccine
Sponsored by
About this trial
This is an interventional treatment trial for Leishmaniasis, Mucocutaneous focused on measuring Leishmaniasis, Subunit vaccine, therapeutic, T-cell, pentavalent antimony
Eligibility 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.
Sites / Locations
- Clínica de Leishmaniasis, Hospital Nacional Sur Este EsSalud
- Universidad Peruana Cayetano Heredia
Outcomes
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
Full Information
NCT ID
NCT00111514
First Posted
May 20, 2005
Last Updated
February 13, 2007
Sponsor
Access to Advanced Health Institute (AAHI)
Collaborators
Bill and Melinda Gates Foundation
1. Study Identification
Unique Protocol Identification Number
NCT00111514
Brief Title
Study to Evaluate the Leish-111F + MPL-SE Vaccine in the Treatment of Mucosal Leishmaniasis
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2007
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Access to Advanced Health Institute (AAHI)
Collaborators
Bill and Melinda Gates Foundation
4. Oversight
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leishmaniasis, Mucocutaneous
Keywords
Leishmaniasis, Subunit vaccine, therapeutic, T-cell, pentavalent antimony
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
48 (false)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
Leish-111f + MPL-SE vaccine
Primary Outcome Measure Information:
Title
Occurrence of dose-limiting toxicity
Title
Adverse events
Secondary Outcome Measure Information:
Title
IgG and T-cell response to Leish-111f vaccine
Title
Leish-111f skin test reactivity
Title
Safety of the vaccine with respect to the clinical course of mucosal leishmaniasis
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alejandro Llanos-Cuentas, MD
Organizational Affiliation
Universidad Peruana Cayetano Heredia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Franco M Piazza, MD, MPh
Organizational Affiliation
Access to Advanced Health Institute (AAHI)
Official's Role
Study Director
Facility Information:
Facility Name
Clínica de Leishmaniasis, Hospital Nacional Sur Este EsSalud
City
Cusco
Country
Peru
Facility Name
Universidad Peruana Cayetano Heredia
City
Lima
ZIP/Postal Code
100
Country
Peru
12. IPD Sharing Statement
Citations:
PubMed Identifier
20851080
Citation
Llanos-Cuentas A, Calderon 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. doi: 10.1016/j.vaccine.2010.08.092. Epub 2010 Sep 17.
Results Reference
derived
Learn more about this trial
Study to Evaluate the Leish-111F + MPL-SE Vaccine in the Treatment of Mucosal Leishmaniasis
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