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

• ClinicalTrials.gov Identifier: NCT01033929
• Recruitment Status: Completed
• First Posted: December 17, 2009
• Last Update Posted: January 21, 2013
• Sponsor: Statens Serum Institut
• Information provided by (Responsible Party): Statens Serum Institut

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Tuberculosis	Biological: rdESAT-6 + rCFP-10 (C-Tb)	Phase 1

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).

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 38 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, 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
• Study Start Date: January 2010
• Actual Primary Completion Date: November 2010
• Actual Study Completion Date: November 2010

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. 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 ]

Secondary Outcome Measures :

1. 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 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Aggerbeck H, Giemza R, Joshi P, Tingskov PN, Hoff ST, Boyle J, Andersen P, Lewis DJ. Randomised clinical trial investigating the specificity of a novel skin test (C-Tb) for diagnosis of M. tuberculosis infection. PLoS One. 2013 May 14;8(5):e64215. doi: 10.1371/journal.pone.0064215. Print 2013.

• Responsible Party: Statens Serum Institut
• ClinicalTrials.gov Identifier: NCT01033929
• Other Study ID Numbers: TESEC-02; 2009-012984-33 ( Other Identifier: EudraCT Number )
• First Posted: December 17, 2009
• Last Update Posted: January 21, 2013
• Last Verified: January 2013

Keywords provided by Statens Serum Institut:

tuberculosis; ESAT-6; CFP-10; skin test; diagnostic test

Additional relevant MeSH terms:

Tuberculosis; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections