Comparison of Diagnostic Performance of C-Tb to QuantiFERON®-TB, in Combination With a Safety Assessment of C-Tb vs Tuberculin PPD RT23 SSI
Condition: Tuberculosis
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Phase 3

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.
    

Intervention name(s): C-Tb; 2 T.U. Tuberculin PPD RT 23 SSI
Intervention type(s): Biological; Biological
Intervention description(s): 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; 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
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Diagnostic