Safety and Risk of Sensitisation of the rdESAT-6 + rCFP-10 Skin Test Following Repeated Intradermal Administration

Phase 1 Completed 42 enrolled Statens Serum Institut

Non-randomizedParallel-groupOpen-labelDiagnostic

Summary

The primary objective is to assess the safety of three dose levels (0.01, 0.1 and 1.0 µg) of the rdESAT-6 + rCFP-10 skin test reagent when injected into healthy adults. The secondary objective is to assess the risk of sensitisation of 0.01 and 0.1 µg rdESAT-6 + rCFP-10 when injected twice with time intervals of 6 or 12 weeks to healthy adults.

Timeline

Start: 2008-11
Primary completion: 2009-07
Completion: 2009-07

Publications

Bergstedt W, Tingskov PN, Thierry-Carstensen B, Hoff ST, Aggerbeck H, Thomsen VO, Andersen P, Andersen AB. First-in-man open clinical trial of a combined rdESAT-6 and rCFP-10 tuberculosis specific skin test reagent. PLoS One. 2010 Jun 25;5(6):e11277. doi: 10.1371/journal.pone.0011277.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	rdESAT-6 + rCFP-10	Diagnostic / imaging agent	0.01 ug	Other
Subject	rdESAT-6 + rCFP-10	Diagnostic / imaging agent	0.1 ug	Other
Subject	rdESAT-6 + rCFP-10	Diagnostic / imaging agent	1 ug	Other

Safety and Risk of Sensitisation of the rdESAT-6 + rCFP-10 Skin Test Following Repeated Intradermal Administration

Summary

Timeline

Publications

Drugs

Indications