Leprosy Skin Test Antigens Trial
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.
Timeline
- Start
- 2002-04
- Primary completion
- 2009-09
- Completion
- 2009-09
Outcome
Missed primary endpoint
paper both antigens at the low dose exhibited low sensitivity at 20% and 25% in BT/TT leprosy patients PMID 24874401 ↗
paper At a sensitivity rate of 20-25% these antigens are not suitable as a skin test for the detection of the early stages of leprosy infection; PMID 24874401 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | tuberculin | Diagnostic / imaging agent | 2 unknown | — |
| Subject | tuberculin | Diagnostic / imaging agent | 5 unknown | — |