NCT01920750

Leprosy Skin Test Antigens Phase 1

Phase I Study to Evaluate New Leprosy Skin Test Antigens: MLSA-LAM and MLCwA

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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 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. 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. The rubber stopper of the vial will be wiped with a sterile piece of cotton moistened with alcohol and allowed to dry.It is expected that all concentrations of the two leprosy skin test antigens will evoke similar negative responses. If so, all three concentrations will be used for subsequent studies. This protocol is linked to study 98-202.

Conditions

• Leprosy

Interventions

Type	Name	Description
BIOLOGICAL	MLCwA	Antigen MLSA-LAM is a pellet extracted 3x followed by removal of SDS by column chromatography. Contains many of the same proteins
BIOLOGICAL	MLSA-LAM	Antigen MLSA-LAM is derived from M. leprae extract following sonication and centrifugation, leaving the cytosol (MLSA). Contains soluble protein antigens of M. leprae
OTHER	Mock Antigen	Physiological saline

Timeline

• Start date: 1989-01-01
• Primary completion: 1999-02-01
• Completion: 1999-02-01
• First posted: 2013-08-12
• Last updated: 2014-07-25