Status:
COMPLETED
Leprosy Skin Test Antigens Phase 1
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Leprosy
Eligibility:
All Genders
18-40 years
Phase:
PHASE1
Brief Summary
This is a small Phase I trial to evaluate the safety of the use as skin test antigens of the immunologically active proteins from the soluble/cytosol and insoluble cell wall of Mycobacterium leprae. T...
Detailed Description
This is a small Phase I trial to evaluate the safety of the use as skin test antigens of the immunologically active proteins from the soluble/cytosol and insoluble cell wall of Mycobacterium leprae. T...
Eligibility Criteria
Inclusion
- Born in the United States (less chance of previous exposure to tuberculosis or leprosy)
- Healthy individuals who are free of any evidence of leprosy or tuberculosis by established clinical examinations
- Between the ages of 18 and 40 years old
- Females of child-bearing age (defined from the period of menarche to menopause, usually between the ages of 15 to 45), certified as not pregnant (as determined by a pregnancy test performed within 7 days prior to admission into the study)
- Agreement to participate in the study after verbal explanation by the physician and nurses and signing of an informed consent form.
- Weight greater than 100 lbs. (female) and.140 lbs. (male)
- No known hypersensitivities or allergies
- Negative tuberculin skin test (as determined by skin tests performed 3 weeks prior to study entry)
Exclusion
- Pregnant or lactating females
- Oral corticosteroid treatment
- Chronic illness
- Immunosuppressive condition
- Tuberculosis
- Leprosy
- Age \<18 or \>40
- Weight \<100 lbs. (female) or \<140 lbs. (male)
- Positive tuberculin skin test
- Extensive travel (2-3 trips/year) in leprosy/tuberculosis endemic regions
Key Trial Info
Start Date :
January 1 1989
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 1999
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01920750
Start Date
January 1 1989
End Date
February 1 1999
Last Update
July 25 2014
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