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Leprosy Skin Test Antigens Trial

NCT00128193 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2014-12-24

Study results available
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Summary

The purpose of this study is to see how healthy people and leprosy patients react to 2 new skin tests for detecting leprosy. The study will evaluate the new skin tests that may aid in measuring the number of people exposed to leprosy and enable its diagnosis and treatment at an earlier stage. Participant's ages 18-60 living in Kathmandu, Nepal will be enrolled. Stages A and B of the study will use the skin test in healthy volunteers. Stage C will use the skin test in high risk volunteers (including individuals with leprosy), healthy individuals in contact with leprosy patients and individuals with tuberculosis (TB, lung disease). Study procedures will include injections, physical exam, and blood testing. Injection sites will be checked several times during the participant's study involvement (5 hours of time spread over approximately 1 month). Volunteers screened for the study, which have leprosy or tuberculosis will be treated or referred for treatment.

Conditions

  • Leprosy

Interventions

BIOLOGICAL

Tuberculin, Purified Protein Derivative

A tuberculin skin test used to diagnose latent tuberculosis (TB) infection. 2 TU dose

OTHER

MLSA-LAM

Mycobacterium leprae soluble antigen with minimal amounts of immunosuppressive lipoglycans; dosages 0.1 and 1.0 micrograms; administered in sterile diluent 0.9% saline (NaCl).

OTHER

MLCwA

Cell wall-associated proteins of Mycobacterium leprae; dosages 0.1 and 1.0 micrograms; administered in sterile diluent 0.9% saline (NaCl).

BIOLOGICAL

Tuberculin, Purified Protein Derivative

Licensed TB reagent, 100 microliters, 5 TU dose.

OTHER

Placebo

Saline (NaCl) serves as a diluent control in Stage A and B only.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2002-04-30
Primary Completion
2009-09-30
Completion
2009-09-30

Countries

  • United States
  • Nepal

Study Locations

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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 NCT00128193 on ClinicalTrials.gov