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

January 18, 2013 updated by: Statens Serum Institut

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

38

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • London SW17 0RE
      • London, London SW17 0RE, United Kingdom, SW17 0RE
        • St George's University of London

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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).
Time Frame: Within 28 days after the injections
Within 28 days after the injections

Secondary Outcome Measures

Outcome Measure
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
Time Frame: Within 28 days after the injections
Within 28 days after the injections

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Statens Serum Institut

Investigators

  • Study Director: Pernille N Tingskov, Statens Serum Institut
  • Principal Investigator: David JM Lewis, Professor, St George's, University of London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (ACTUAL)

November 1, 2010

Study Completion (ACTUAL)

November 1, 2010

Study Registration Dates

First Submitted

December 16, 2009

First Submitted That Met QC Criteria

December 16, 2009

First Posted (ESTIMATE)

December 17, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

January 21, 2013

Last Update Submitted That Met QC Criteria

January 18, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TESEC-02
  • 2009-012984-33 (OTHER: EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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