Safety Study to Evaluate the Leish-111f + MPL-SE Vaccine in the Prevention of Cutaneous Leishmaniasis in Healthy Subjects Previously Exposed to the Leishmania Parasite

Study Overview
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Brief Summary
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This study will evaluate the safety of the Leish-111f + MPL-SE vaccine in adult subjects with a previous exposure to the Leishmania parasite (but without current or past history of leishmaniasis).

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 1, open-label study to evaluate the safety, tolerability and immunogenicity in Montenegro skin test (MST)-positive 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). The vaccine will be given to each study subject three times at 4 week intervals.

Official Title
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A Phase 1, Open-Label Study to Evaluate the Safety, Tolerability, and Immunogenicity of the Leish-111f + MPL-SE Vaccine in Montenegro Skin Test-Positive 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 positive Montenegro skin test (reaction >5 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. Pregnant or nursing 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


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 chemistries at Screening and Days 7, 35, 63, and 84 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IgG and T-cell responses to the Leish-111f protein: immunological evaluations at Days 0, 84, and 168 |  |  | 
| Skin test reactivity to the Leish-111f protein at Days 0, 84, and 168 |  |  | 

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