NCT01631266

Comparison of Diagnostic Performance of C-Tb to QuantiFERON®-TB, in Combination With a Safety Assessment of C-Tb vs Tuberculin PPD RT23 SSI

A Phase III Contact Tracing Trial Comparing the Diagnostic Performance of C-Tb to QuantiFERON®-TB Gold In-Tube, in Combination With a Double Blind Randomized Split Body Safety Assessment of C-Tb Versus 2 T.U. Tuberculin PPD RT23 SSI

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 979 (actual)
• Sponsor: Statens Serum Institut · Academic / Other
• Sex: All
• Age: 6 Weeks – 65 Years
• Healthy volunteers: Accepted

Summary

Tuberculosis (TB) continues to be the most important bacterial infection worldwide and therefore new improved diagnostic tests are needed to help doctors in diagnosing TB. We are investigating a new skin test named C-Tb. Like the current tuberculin skin test (PPD), the C-Tb test is injected just under the skin and will, when positive, show redness and/or swelling at the injection site while a negative test will leave no reactions. The aim of this trial is to test the C-Tb skin test in volunteers. The volunteers are divided into four groups: * Negative control group: Must have no history of exposure to a person with tuberculosis disease. * Occasional contact: Must be in contact with a person with tuberculosis disease between 6 hours/week and 6 hours/day * Close contact: Must be in close contact with a person with tuberculosis disease for more than 6 hours/day for at least five days * Positive control group: Must have a confirmed tuberculosis disease within the last 3 years. The goals of this clinical trial are: * To compare the C-Tb test to a blood test, the QuantiFERON test. * To compare the C-Tb test to the PPD test that is currently being used. * To assess the safety of the C-Tb test.

Detailed description

The TESEC-06 trial is an open comparison of the diagnostics performance of C-Tb compared to QuantiFERON®-TB Gold In-Tube, in combination with a double-blind randomized split-body safety assessment of C-Tb versus Tuberculin PPD RT23 SSI. The trial is designed to address the fundamental issue that in the diagnosis of latent tuberculosis (TB) infection, no gold standard exists. Thus, no existing test for latent TB is 100 % sensitive and specific - including the Tuberculin PPD RT23 SSI and QuantiFERON®-TB Gold In-Tube. This will be addressed by evaluating C-Tb positive response rates in 4 groups defined by their estimated risk of infection with MTb. The groups will consist of paediatric and adult participants selected as being either occasional or close contacts to an active pulmonary TB case. In addition a group of confirmed TB cases and a group of participants with no history of exposure to MTb will be included as control groups. 50 participants in the negative control group will be tested with C-Tb alone in order to evaluate whether concomitant administration of C-Tb and Tuberculin PPD RT23 SSI could conceivably result in larger or smaller areas of induration to one or both tests as a result of expanding the clone of sensitised T-cells i.e. since Tuberculin PPD RT23 SSI includes among several other antigens ESAT-6 and CFP-10 and C-Tb also contains both these antigens.

Conditions

• Tuberculosis

Interventions

Type	Name	Description
BIOLOGICAL	C-Tb	The C-Tb agent is administered by the Mantoux injection technique to each volunteer in the RIGHT or LEFT forearm according to a double blind randomisation scheme
BIOLOGICAL	2 T.U. Tuberculin PPD RT 23 SSI	The 2 T.U. Tuberculin PPD RT 23 SSI agent is administered by the Mantoux injection technique to each volunteer in the RIGHT or LEFT forearm according to a double blind randomisation scheme

Timeline

• Start date: 2012-07-01
• Primary completion: 2014-10-01
• Completion: 2014-10-01
• First posted: 2012-06-29
• Last updated: 2015-04-17

Locations

13 sites across 1 country: Spain