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

Sponsor

Statens Serum Institut (Other)

Overall Status

Completed

CT.gov ID

NCT01033929

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

3.8

Patients Per Site Per Month

Study Details

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

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 :

Jan 1, 2010

Actual Primary Completion Date :

Nov 1, 2010

Actual Study Completion Date :

Nov 1, 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

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)

Other Names:

rdESAT-6 + rCFP-10

C-Tb

Outcome Measures

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). [Within 28 days after the injections]

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 [Within 28 days after the injections]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

The patient:

Has signed an informed consent
Is willing and likely to comply with the trial procedures
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

Has a positive T-spot assay or a QuantiFERON®-TB Gold In Tube test
Is prepared to grant authorized persons access to their medical records

Exclusion Criteria:

The patient:

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)
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)
Has a known congenital or acquired immune deficiency
Has a disease affecting the lymphoid organs (e.g., Hodgkin's disease, lymphoma, leukaemia, sarcoidosis)
Is infected with HIV
Has severe scarring, burn, rash, eczema, psoriasis, or any other skin disease at or near the injection sites
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
Is actively participating in another clinical trial
Is pregnant according to urine pregnancy test at inclusion
Has a condition which in the opinion of the investigator is not suitable for participation in the study