Leprosy Clinical Trial
Official title:
Phase I Study to Evaluate New Leprosy Skin Test Antigens: MLSA-LAM and MLCwA
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. The overall objective is to generate new leprosy skin-test antigens, equivalent to tuberculin-PPD in the tuberculosis context, to be used (I) for the early diagnosis of leprosy; and (ii) as epidemiological tools to measure the incidence of disease. Evaluating new leprosy skin test antigens may provide a better way to diagnose leprosy in its early stages of infection. With the early administration of drug therapy, infected individuals can then be cured of this disease before nerve damage occurs or nodules (lepromas) start to develop on the skin. Ten healthy, leprosy-unexposed, tuberculin-negative volunteers, 18-40 years old, from within the staff of the Mycobacteria Research Laboratories, Department of Microbiology, Colorado State University, Fort Collins, Colorado, will be selected.
Status | Completed |
Enrollment | 10 |
Est. completion date | February 1999 |
Est. primary completion date | February 1999 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 40 Years |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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 |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
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National Institute of Allergy and Infectious Diseases (NIAID) |
Rivoire BL, Groathouse NA, TerLouw S, Neupane KD, Ranjit C, Sapkota BR, Khadge S, Kunwar CB, Macdonald M, Hawksworth R, Thapa MB, Hagge DA, Tibbals M, Smith C, Dube T, She D, Wolff M, Zhou E, Makhene M, Mason R, Sizemore C, Brennan PJ. Safety and efficacy — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Range of concentration (1, 10, and 25 micrograms/ml) responses in the two leprosy skin test antigens in the control and mock antigens | Up to 28 days post injection | No | |
Primary | Incidence of leprosy | Up to 28 days post injection | Yes |
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