CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 260 enrolled
Drug / intervention
Tuberculin, Purified Protein Derivative +4 morebiological
Likely dose
MLSA-LAM 0.1 and 1.0 micrograms or MLCwA 0.1 and 1.0 micrograms administered intradermally in 0.9% saline; Tuberculin PPD 2 TU or 5 TUAI-extracted
Key inclusion· 8
  • ✓Age 18-60 years
  • ✓Weight >30 kg (female) or >38 kg (male)
  • ✓Nepali residents, including expatriates from India
  • ✓Healthy non-contacts: no household or working contact with TB or leprosy
Key exclusion· 10
  • ✕Pregnant or lactating females
  • ✕Currently on oral corticosteroids or other immunosuppressive treatment
  • ✕Cancer, diabetes, or other chronic illness
  • ✕Known hypersensitivities or allergies

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00128193
NCT00128193Phase 2Completed
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Two New Leprosy Skin Test Antigens: MLSA-LAM and MLCwA Phase II Study in a Leprosy-Endemic Region

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Aug 9, 2005·Updated Dec 24, 2014

In Brief

A Phase 2 clinical trial evaluating Tuberculin, Purified Protein Derivative, MLSA-LAM, and 2 other interventions for Leprosy. Completed, enrolled 260 participants across 6 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLeprosy
CountriesNepal, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 9, 2005
Enrollment StartApr 1, 2002
Primary CompletionSep 1, 2009
TodayJul 2, 2026
Enrollment to primary: 7.4 yearsPosted 20.9 years ago

Interventions

Tuberculin, Purified Protein Derivativebiological

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

MLSA-LAMother

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).

MLCwAother

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

Tuberculin, Purified Protein Derivativebiological

Licensed TB reagent, 100 microliters, 5 TU dose.

Placeboother

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