Study to Evaluate the Leish-111f + MPL-SE Vaccine in Healthy Adults Not Previously Exposed to Leishmania Parasite

Study Overview
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Brief Summary
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This study will evaluate the safety and immunogenicity of the Leish-111f + MPL-SE vaccine in adult subjects who have no evidence of previous exposure to the Leishmania parasite.

Detailed Description
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Cutaneous leishmaniasis is a disfiguring disease that can progress to mucosal leishmaniasis, a more serious and possibly fatal form of Leishmania disease. All available medical therapies require weeks of treatment and cause significant toxicity. It appears that Leishmania infections can be eliminated or prevented by T helper 1 immune responses. These findings argue that a vaccine that generates a T helper 1 response against the parasite will prevent the infection and disease. This is a phase 2, randomized, double blind, placebo-controlled study to evaluate the safety, tolerability and immunogenicity in Montenegro skin test (MST)-negative healthy adults of an investigational vaccine being developed for the prophylaxis of cutaneous leishmaniasis. The vaccine, identified as Leish-111f + MPL-SE, consists of a recombinant three-antigen Leishmania polyprotein (Leish-111f, 10 μg) together with the adjuvant MPL-SE (25 μg). In addition, the safety and immunogenicity of the vaccine will be compared to that of the Leish-111f protein (10 μg) given alone. The vaccine, Leish-111f protein alone or placebo will be given to each study subject three times at 4 week intervals.

Official Title
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A Study to Evaluate the Safety, Tolerability, and Immunogenicity of the Leish-111f + MPL-SE Vaccine Compared to the Leish-111f Protein Alone in Montenegro Skin Test-Negative Healthy Adults

Conditions
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Cutaneous Leishmaniasis

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: Must have negative Montenegro skin test (0 mm) Must be in good general health with normal lab values Negative for HIV, hepatitis B and C Exclusion Criteria: History of leishmaniasis or exposure to Leishmania vaccine or MPL-SE Nursing or pregnant female

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
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 |
| --- | --- | --- |
| Adverse events |  |  | 
| Dose-limiting toxicities: hematology and serum chemistry evaluations at Screening, Days 7, 35, 63, 84 |  |  | 
| T-cell IFN-γ response to the Leish-111f protein: immunology evaluations at Days 0, 84, 168 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| T-cell IL-5 response to the Leish-111f protein |  |  | 
| Antibody responses to the Leish-111f protein |  |  | 
| Skin test reactivity to the Leish-111f protein at Days 84, 168 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prevention, Leishmaniasis, Subunit Vaccine, T cell