Cutaneous Leishmaniasis Clinical Trial
Official title:
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
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | March 2006 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 40 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Colombia | Programa de Estudio y Control de Enfermedades Tropicales (PECET) | Medellin |
Lead Sponsor | Collaborator |
---|---|
IDRI | Bill and Melinda Gates Foundation |
Colombia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Adverse events | |||
Primary | Dose-limiting toxicities: hematology and serum chemistry evaluations at Screening, Days 7, 35, 63, 84 | |||
Primary | T-cell IFN-? response to the Leish-111f protein: immunology evaluations at Days 0, 84, 168 | |||
Secondary | T-cell IL-5 response to the Leish-111f protein | |||
Secondary | Antibody responses to the Leish-111f protein | |||
Secondary | Skin test reactivity to the Leish-111f protein at Days 84, 168 |
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