Study to Evaluate the Leish-111f + MPL-SE Vaccine in Healthy Adults Not Previously Exposed to Leishmania Parasite
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
1 other identifier
interventional
60
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Aug 2005
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 18, 2005
CompletedFirst Posted
Study publicly available on registry
July 21, 2005
CompletedStudy Start
First participant enrolled
August 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2006
CompletedMay 5, 2006
May 1, 2006
July 18, 2005
May 4, 2006
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (3)
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
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- History of leishmaniasis or exposure to Leishmania vaccine or MPL-SE
- Nursing or pregnant female
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Programa de Estudio y Control de Enfermedades Tropicales (PECET)
Medellín, Colombia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Franco M Piazza, MD, MPH
Access to Advanced Health Institute (AAHI)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 18, 2005
First Posted
July 21, 2005
Study Start
August 1, 2005
Study Completion
March 1, 2006
Last Updated
May 5, 2006
Record last verified: 2006-05