Cutaneous Leishmaniasis Clinical Trial
Official title:
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
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).
Status | Completed |
Enrollment | 12 |
Est. completion date | February 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 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 |
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Colombia | Programa de Estudio y Control de Enfermedades Tropicales (PECET) | Medellín |
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 chemistries at Screening and Days 7, 35, 63, and 84 | |||
Secondary | IgG and T-cell responses to the Leish-111f protein: immunological evaluations at Days 0, 84, and 168 | |||
Secondary | Skin test reactivity to the Leish-111f protein at Days 0, 84, and 168 |
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