NCT00793702

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

An Open Phase I Clinical Trial on the Safety and Risk of Sensitisation by Escalating Doses and Repeated Injections of the rdESAT-6 + rCFP-10 Skin Test Reagent Following Intradermal Administration to Healthy Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Statens Serum Institut · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Tuberculosis

Interventions

Type	Name	Description
BIOLOGICAL	rdESAT-6 + rCFP-10	rdESAT-6 + rCFP-10 skin test administered intradermally by the mantoux injection technique

Timeline

• Start date: 2008-11-01
• Primary completion: 2009-07-01
• Completion: 2009-07-01
• First posted: 2008-11-19
• Last updated: 2013-01-21

Locations

1 site across 1 country: Denmark