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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Leishmaniasis, Mucocutaneous

Intervention / Treatment
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* Biological: Leish-111f + MPL-SE vaccine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Leish-111f + MPL-SE vaccine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of dose-limiting toxicity |  |  | 
| Adverse events |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Leishmaniasis, Subunit vaccine, therapeutic, T-cell, pentavalent antimony