A Trial in Subjects Suspected to Have Tuberculosis, Comparing the Diagnostic Performance of C-Tb to QuantiFERON®, in Combination With a Safety Assessment of C-Tb Versus Tuberculin PPD RT23 SSI
Condition: Tuberculosis
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Phase 3

Summary: 
      Tuberculosis (TB) continues to be one of the most serious bacterial infections worldwide and
      therefore new improved diagnostic tests are needed to help doctors in diagnosing TB.

      The new skin test is 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 investigators hope that
      this new C-Tb skin test will be more precise (specific) than the PPD test, as the PPD test
      e.g. may show a reaction if the person tested is BCG vaccinated.

      The aim of this trial is to test the C-Tb skin test in volunteers suspected of having TB
      disease.

      With focus on age, HIV status and CD4 count the following analyses are done (in an overall
      perspective):

        -  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-05 trial is an open comparison of the diagnostics performance of C-Tb compared to
      the QuantiFERON®-TB Gold In-Tube, in combination with a double-blind randomized split-body
      safety assessment of C-Tb versus to 2 T.U. Tuberculin PPD RT23 SSI.

      The trial is a multi-centre Phase III clinical trial designed specifically to address C-Tb in
      relation to the paediatric population and to HIV infection. The intention is to evaluate how
      the C-Tb test performs in the paediatric population with respect to safety, and to ensure
      that SSI will be able to extrapolate data obtained in an adult population to the paediatric
      population.

      Furthermore, the intention is both to evaluate the diagnostic performance and safety of C-Tb
      in HIV infected individuals and to evaluate whether SSI will be able to extrapolate data
      obtained in a non-HIV population to a HIV population.

      The trial population will consist of paediatric participants with suspected TB infection and
      adult participants suspected to have TB disease. Furthermore a control group of 100 children
      between 5 - 11 years of age with no symptoms or known exposure will be recruited from an area
      with a "low" prevalence of TB (an area with an incidence rate < 299/100,000 per year, the
      average rate of TB in South Africa in 2005 was 645/100,000 per year.

      The trial will be conducted in South Africa where the prevalence of HIV infection is high and
      MTb infections are endemic.

      BCG vaccination at birth has been common practice since 1961 in South Africa. Thus most of
      the participants are presumed BCG vaccinated.
    

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