A Safety and Dose Finding Trial of C-Tb, When Given to Adult Patients Recently Diagnosed With Active Tuberculosis (TESEC-02)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Statens Serum Institut
ClinicalTrials.gov Identifier:
NCT01033929
First received: December 16, 2009
Last updated: January 18, 2013
Last verified: January 2013
  Purpose

The primary objective is to assess the safety of two doses of C-Tb (0.01 and 0.1 µg/0.1 mL) when administered intradermally by the Mantoux technique to patients in the acute phase of treatment against active TB. The secondary objectives are to assess the immune response of two doses (0.01 and 0.1 µg/0.1 mL) of C-Tb from the size of induration and to assess the safety of unpreserved C-Tb and C-Tb preserved with 0.5% phenol (local reactions).


Condition Intervention Phase
Tuberculosis
Biological: rdESAT-6 + rCFP-10 (C-Tb)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: A Safety and Dose Finding Trial of the Diagnostic Test C-Tb, When Given Intradermally by the Mantoux Technique to Adult Patients Recently Diagnosed With Active TB

Resource links provided by NLM:


Further study details as provided by Statens Serum Institut:

Primary Outcome Measures:
  • Local and systemic adverse reactions at the injection sites within 28 days after application of the tests (0.01/0.1 µg C-Tb). [ Time Frame: Within 28 days after the injections ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Immune response of 2 doses (0.01 and 0.1 µg/0.1 mL) of C-Tb from the size of induration; the safety of unpreserved C-Tb and C-Tb preserved with 0.5% phenol and the pain associated with the injection of unpreserved C-Tb and preserved C-Tb [ Time Frame: Within 28 days after the injections ] [ Designated as safety issue: Yes ]

Enrollment: 38
Study Start Date: January 2010
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 0.01µg C-Tb
12-24 patients depending on a safety evaluation will receive a low dose of 0.01 µg/0.1 mL C-Tb without phenol in the RIGHT or LEFT arm and 0.01 µg/0.1 mL C-Tb with phenol in the opposite arm, in a double blind manner.
Biological: rdESAT-6 + rCFP-10 (C-Tb)
rdESAT-6 + rCFP-10 (C-Tb) skin test +/- phenol administered intradermally by the mantoux injection technique. Each patient receives the unpreserved version in one arm and the preserved version in the other arm in double blind manner.
Other Names:
  • rdESAT-6 + rCFP-10
  • C-Tb
Experimental: 0.1µg C.Tb
12-24 patients depending on a safety evaluation will receive a high dose of 0.1 µg/0.1 mL C-Tb without phenol in the RIGHT or LEFT arm and 0.01 µg/0.1 mL C-Tb with phenol in the opposite arm, in a double blind manner.
Biological: rdESAT-6 + rCFP-10 (C-Tb)
rdESAT-6 + rCFP-10 (C-Tb) skin test +/- phenol administered intradermally by the mantoux injection technique. Each patient receives the unpreserved version in one arm and the preserved version in the other arm in double blind manner.
Other Names:
  • rdESAT-6 + rCFP-10
  • C-Tb

Detailed Description:

This clinical trial is a single centre phase Ib open dose adjustment study with respect to the dose of C-Tb combined with a double blind randomised, split-body comparison of unpreserved C-Tb and C-Tb preserved with 0.5% phenol (each patient receives the unpreserved version in one arm and the preserved version in the other arm).

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

The patient:

  1. Has signed an informed consent
  2. Is willing and likely to comply with the trial procedures
  3. Has been diagnosed with active TB and has been in treatment ≤ 60 days at the time of inclusion

    • has 1 documented positive sputum smear microscopy result
    • has positive culture
    • has a positive PCR result for tuberculosis
    • has a compatible clinical picture of TB with the intention to treat
  4. Has a positive T-spot assay or a QuantiFERON®-TB Gold In Tube test
  5. Is prepared to grant authorized persons access to their medical records

Exclusion Criteria:

The patient:

  1. Has been in treatment with a product which is likely to modify the immune response within 3 months prior to the day of inclusion (e.g., immunoglobulin, systemic corticosteroids, methotrexate, azathioprine, cyclosporine or blood products)
  2. Has been vaccinated with a live vaccine within 6 weeks prior to the day of inclusion (e.g. BCG, MMR, yellow fever, oral typhoid vaccines)
  3. Has a known congenital or acquired immune deficiency
  4. Has a disease affecting the lymphoid organs (e.g., Hodgkin's disease, lymphoma, leukaemia, sarcoidosis)
  5. Is infected with HIV
  6. Has severe scarring, burn, rash, eczema, psoriasis, or any other skin disease at or near the injection sites
  7. Has a condition where blood drawings pose more than minimal risk for the patient, such as haemophilia, other coagulation disorders, or significantly impaired venous access
  8. Is actively participating in another clinical trial
  9. Is pregnant according to urine pregnancy test at inclusion
  10. Has a condition which in the opinion of the investigator is not suitable for participation in the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01033929

Locations
United Kingdom
St George's University of London
London, London SW17 0RE, United Kingdom, SW17 0RE
Sponsors and Collaborators
Statens Serum Institut
Investigators
Study Director: Pernille N Tingskov Statens Serum Institut
Principal Investigator: David JM Lewis, Professor St George's, University of London
  More Information

No publications provided by Statens Serum Institut

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Statens Serum Institut
ClinicalTrials.gov Identifier: NCT01033929     History of Changes
Other Study ID Numbers: TESEC-02, 2009-012984-33
Study First Received: December 16, 2009
Last Updated: January 18, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Statens Serum Institut:
tuberculosis
ESAT-6
CFP-10
skin test
diagnostic test

Additional relevant MeSH terms:
Tuberculosis
Actinomycetales Infections
Bacterial Infections
Gram-Positive Bacterial Infections
Mycobacterium Infections

ClinicalTrials.gov processed this record on October 30, 2014