Status:
COMPLETED
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
Lead Sponsor:
Access to Advanced Health Institute (AAHI)
Collaborating Sponsors:
Bill and Melinda Gates Foundation
Conditions:
Cutaneous Leishmaniasis
Eligibility:
All Genders
18-40 years
Phase:
PHASE1
Brief Summary
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
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...
Eligibility Criteria
Inclusion
- 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
- History of leishmaniasis or exposure to Leishmania vaccine or MPL-SE.
- Pregnant or nursing female
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
End Date :
February 1 2006
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00121849
Start Date
August 1 2005
End Date
February 1 2006
Last Update
May 5 2006
Active Locations (1)
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1
Programa de Estudio y Control de Enfermedades Tropicales (PECET)
Medellín, Colombia