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Leprosy Skin Test Antigens Phase 1

NCT01920750 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2014-07-25

No results posted yet for this study

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.

Conditions

  • Leprosy

Interventions

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

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
1989-01-31
Primary Completion
1999-02-28
Completion
1999-02-28

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01920750 on ClinicalTrials.gov