drugset / Trial / NCT01242475

A Trial of the C-Tb Skin Test, When Given Intradermally to Healthy Volunteers Previously Vaccinated With BCG

NCT01242475

Phase 2 Completed 151 enrolled Statens Serum Institut
RandomizedParallel-groupQuadruple-blindDiagnostic

Summary

A new, more specific skin test to detect tuberculosis has been developed by Statens Serum Institut in Denmark. The new skin test is named C-Tb and like the current Tuberculin a positive test result will show as redness and/or swelling at the injection site, while a negative test will leave no reactions. The aim of this study is to test the C-Tb skin test in healthy adults previously BCG vaccinated to determine if healthy non tuberculosis infected individuals has a truly negative test result (this is called determining the specificity of the skin test). To be able to compare the new skin test with the current Tuberculin skin test volunteers will be injected with both the C-Tb and the TST skin test.

Timeline

Start
2011-04
Primary completion
2011-11
Completion
2011-11

Drugs

EvaluationDrugModalityDoseRoute
Subject C-Tb Diagnostic / imaging agent 0.1 ug Other
Subject C-Tb Diagnostic / imaging agent 0.1 ml Other
Comparator tuberculin Diagnostic / imaging agent 2 unknown Other

Indications