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

Study Overview
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Brief Summary
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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
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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).

Official Title
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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

Conditions
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Tuberculosis

Intervention / Treatment
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* Biological: rdESAT-6 + rCFP-10 (C-Tb)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 0.01µg C-Tb<br>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)<br>* 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.<br>* Other names: C-Tb;|
| Experimental: 0.1µg C.Tb<br>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)<br>* 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.<br>* Other names: C-Tb;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tuberculosis, ESAT-6, CFP-10, skin test, diagnostic test