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

NCT ID: NCT01033929

Last Updated: 2013-01-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2010-11-30

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).

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).

Conditions

Tuberculosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

rdESAT-6 + rCFP-10 (C-Tb)

Intervention Type: BIOLOGICAL

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.

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.

Group Type: EXPERIMENTAL

rdESAT-6 + rCFP-10 (C-Tb)

Intervention Type: BIOLOGICAL

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.

Interventions

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.

Intervention Type: BIOLOGICAL

Other Intervention Names

rdESAT-6 + rCFP-10; C-Tb

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Statens Serum Institut

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pernille N Tingskov

Role: STUDY_DIRECTOR

Statens Serum Institut

David JM Lewis, Professor

Role: PRINCIPAL_INVESTIGATOR

St George's, University of London

Locations

St George's University of London

London, London SW17 0RE, United Kingdom

Countries

United Kingdom

References

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.

Reference Type: DERIVED

PMID: 23691171 (View on PubMed)

Other Identifiers

2009-012984-33

Identifier Type: OTHER

Identifier Source: secondary_id

TESEC-02

Identifier Type: -

Identifier Source: org_study_id