Clinical Trial: Leprosy Skin Test Antigens Phase 1
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Phase I Study to Evaluate New Leprosy Skin Test Antigens: MLSA-LAM and MLCwA
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. 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.
Detailed 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. 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, ages 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 for this study. The volunteers will be recruited by direct contact after placing notices in the Department of Microbiology at Colorado State University. There are approximately 40 faculty/staff/students in this population and all are routinely tested (PPD skin-testing or chest X-ray) by the staff at the Hartshorn Health Service Center in the context of the Department's tuberculosis research. Five individuals will be selected for testing MLSA-LAM and five will receive MLCwA. Each will receive single 0.1 ml intracutaneous injections of three titrated doses (1, 10 and 25 )lg/ml) of the skin-test antigen, one of mock antigen (i.e., physiological saline), and one of control antigen (the product now in use; Rees MLSA, 10 )lg), divided equally between the subject's two arms. Results will be recorded at 15 min, 48 h, 72 h, and 28 days post-injection. The test dose will be administered with a sterile1 ml syringe calibrated in tenths and fitted with a sterile, one-half inch, 26 or 27 gauge needle.
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Current Primary Outcome:
- Range of concentration (1, 10, and 25 micrograms/ml) responses in the two leprosy skin test antigens in the control and mock antigens [ Time Frame: Up to 28 days post injection ]
- Incidence of leprosy [ Time Frame: Up to 28 days post injection ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: National Institute of Allergy and Infectious Diseases (NIAID)
Dates:
Date Received: July 25, 2013
Date Started: January 1989
Date Completion:
Last Updated: July 24, 2014
Last Verified: August 2013
