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NCT Number: NCT01033929

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

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).

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

St George's University of London

London, London SW17 0RE, SW17 0RE, United Kingdom

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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.

Other names: rdESAT-6 + rCFP-10, C-Tb

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Statens Serum Institut

Other

Registry information

Official study 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

Acronym: TESEC-02

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Dec 17, 2009
Registry last updated
Jan 21, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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