Safety Study Investigating if Concomitant Injections of C-Tb and 2 T.U Tuberculin Affect Induration Responses (TESEC-07)

This study is currently recruiting participants.
Verified January 2013 by Statens Serum Institut
Sponsor:
Information provided by (Responsible Party):
Statens Serum Institut
ClinicalTrials.gov Identifier:
NCT01779102
First received: January 18, 2013
Last updated: April 10, 2014
Last verified: January 2013
  Purpose

A new, more specific skin test to detect tuberculosis has been developed by Statens Serum Institut in Denmark. The new skin test is named C-Tb and like the current Tuberculin a positive test result will show as redness and/or induration at the injection site, while a negative test will leave no reactions.

The aim of this study is to address if the size of induration and the sensitivity of C-Tb is influenced by concomitant injections of C-Tb and Tuberculin. Furthermore, the intention is to evaluate the safety of C-Tb when injected alone or concomitantly with Tuberculin.


Condition Intervention Phase
Tuberculosis
Biological: C-Tb
Biological: Tuberculin PPD RT 23 SSI
Biological: C-Tb / Tuberculin PPD RT 23 SSI
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: A Phase II/III Trial Investigating if Concomitant Injections of the Diagnostic Agents C-Tb and 2 T.U Tuberculin PPD RT 23 SSI Affect the Induration Responses in Combination With a Safety Assessment of C-Tb

Resource links provided by NLM:


Further study details as provided by Statens Serum Institut:

Primary Outcome Measures:
  • To compare the size of induration of C-Tb and PPD RT 23 if injected alone or concomitantly in Tuberculosis infected patients (HIV positives and HIV negatives) [ Time Frame: Onset from the injection(s) to 28 days after the injections ] [ Designated as safety issue: No ]
  • To assess if concomitant injections of C-Tb and PPD RT 23 influence the tests abilities to identify positive results of Tuberculosis in Tuberculosis infected patients [ Time Frame: Onset from the injection(s) to 28 days after the injections ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To compare the C-Tb test's ability to identify positive results in Tuberculosis infected patients with the in vitro QuantiFERON®TB Gold In Tube assay in blood collected immediately before application of the C-Tb skin test [ Time Frame: Onset from the injection(s) to 28 days after the injections ] [ Designated as safety issue: No ]
  • To compare the C-Tb test's ability to identify positive results in Tuberculosis infected patients with the PPD RT 23 test [ Time Frame: Onset from the injection(s) to 28 days after the injections ] [ Designated as safety issue: No ]
  • To assess the safety of C-Tb skin test by investigating laboratory safety parameters and assessing all adverse events (local and systemic) occurring within 28 days after administration of the C-Tb and/or PPD RT 23 tests [ Time Frame: Onset from the injection(s) to 28 days after the injections ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 450
Study Start Date: October 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 0.1 µg C-Tb
The C-Tb agent is given alone to volunteers in the RIGHT or LEFT forearm according to a double blind randomisation scheme
Biological: C-Tb
C-Tb is administered by the Mantoux injection technique to each volunteer in the RIGHT or LEFT forearm according to a double blind randomisation scheme
Active Comparator: 2 T.U Tuberculin PPD RT 23 SSI
The 2 T.U Tuberculin PPD RT 23 SSI agent is given alone to volunteers in the RIGHT or LEFT forearm according to a double blind randomisation scheme
Biological: Tuberculin PPD RT 23 SSI
Tuberculin is administered by the Mantoux injection technique to each volunteer in the RIGHT or LEFT forearm according to a double blind randomisation scheme
Experimental: 0.1 µg C-Tb / 2 T.U Tuberculin PPD
The C-Tb and 2 T.U Tuberculin PPD RT 23 SSI agents are given concomitantly to volunteers in the RIGHT and LEFT forearms according to a double blind randomisation scheme
Biological: C-Tb / Tuberculin PPD RT 23 SSI
The C-Tb and Tuberculin agents are administered by the Mantoux injection technique to each volunteer in the RIGHT and LEFT forearm according to a double blind randomisation scheme

Detailed Description:

The TESEC-07 trial is a GCP double blind randomised controlled phase II/III trial investigating if concomitant injections of the diagnostic agents C-Tb and 2 T.U Tuberculin PPD RT 23 SSI affect the induration responses in combination with a safety assessment of C-Tb. TESEC-07 is a multi-centre trial and will be conducted in South Africa in patients recently diagnosed with TB comprising 360 HIV negative and 90 HIV positive adults allocated to 3 trial groups.

  • A within group paired comparison of 0.1 μg/0.1 mL C-Tb and PPD RT 23 in 150 TB patients. The C-Tb and PPD RT 23 agents are given concomitantly to each volunteer in the RIGHT AND LEFT forearms according to a randomisation scheme.
  • A group of 150 TB patients will only receive the C-Tb agent randomised to either RIGHT or LEFT forearm.
  • A group of 150 TB patients will only receive the reference agent PPD RT 23 randomised to either RIGHT or LEFT forearm.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria (HIV Negative patients):

  • Has signed an informed consent
  • Aged 18 to 65 years
  • Has been diagnosed with active pulmonary TB:

    1. has a compatible clinical picture of TB according to South African guidelines with the intention to treat and 1 documented positive culture result or
    2. has a compatible clinical picture of TB according to South African Guidelines with the intention to treat and 1 documented positive GeneXpert analysis
  • Is HIV negative confirmed by 2 two rapid tests
  • Is willing and likely to comply with the trial procedures
  • Is prepared to grant authorized persons access to their medical record

Inclusion Criteria (HIV Positive patients):

  • Has signed an informed consent
  • Aged 18-65 years
  • Has been diagnosed with active pulmonary TB:

    1. has a compatible clinical picture of TB according to South African guidelines with the intention to treat and 1 documented positive culture result or
    2. has a compatible clinical picture of TB according to South African Guidelines with the intention to treat and 1 documented positive GeneXpert analysis
  • Is HIV positive confirmed by:

    1. 2 positive rapid tests or
    2. 1 positive rapid tests and an additional confirmatory ELISA
  • A CD4 count has been performed
  • Is willing and likely to comply with the trial procedures
  • Is prepared to grant authorized persons access to their medical records

Exclusion Criteria:

  • Has been in treatment for TB for more than 2 weeks
  • Has a known MDR/XDR-TB
  • Has been vaccinated with a live vaccine within 6 weeks prior to the day of inclusion (e.g. MMR, yellow fever, oral typhoid vaccines) except BCG vaccine
  • Has been tuberculin (TST) tested < 12 months prior to the day of inclusion
  • Is pregnant, breastfeeding or intending to get pregnant
  • Is a female of child bearing potential not willing to use effective barrier (including spermicidal gel), hormonal or intrauterine contraceptive measures during the trial period
  • Has an active disease affecting the lymphoid organs except for HIV (e.g., Hodgkin's disease, lymphoma, leukaemia, sarcoidosis)
  • Has a current skin condition which interferes with the reading of the skin tests e.g. tattoos, severe scarring, burns/sunburns, 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
  • Currently participating in another clinical trial with an investigational or non investigational drug or device, or has participated in another clinical trial within the 3 months prior to dosing
  • Has participated in previous clinical trials investigating the ESAT-6 and/or CFP-10 antigens
  • Has a condition which in the opinion of the investigator is not suitable for participation in the study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01779102

Contacts
Contact: Keertan Dheda, MD, Prof + 27 (0) 21 404 7650 keertan.dheda@uct.ac.za
Contact: Pernille N Tingskov, BN, RN +45 32688505 pnt@ssi.dk

Locations
South Africa
Be Part Yoluntu Centre Recruiting
Paarl, Western Cape, South Africa, 7626
Contact: Elizabeth Hellstrom    + 27 (0) 21 868 3990    boylouw@mweb.co.za   
Principal Investigator: Elizabet Hellstrom, MD         
Worthwhile Clinical Trials Withdrawn
Benoni, South Africa, 1501
TASK, M2, Karl Bremer Hospital, Recruiting
Cape Town, South Africa, 7530
Contact: Zoja Novelijc, MD    + 27 (0) 21 949 7751    dr.zoja@task.org.za   
Principal Investigator: Zoja Novelijc, MD         
Tiervlei Trial Centre, Karl Bremer Hospital Recruiting
Cape Town, South Africa, 7530
Contact: M Siebert, MD    + 27 (0) 21 957 9400    msiebert@ttctrials.co.za   
Principal Investigator: M Siebert, MD         
UCT Lung Institute Recruiting
Cape Town, South Africa, 7925
Contact: Keertan Dheda, MD, Prof    + 27 (0) 21 404 7650    keertan.dheda@uct.ac.za   
Principal Investigator: Keertan Dheda, MD, Prof         
Primecure Medicentre Recruiting
Port Elizabeth, South Africa, 6014
Contact: M Gani, MD    + 27 (0) 41 404 0589    mashra@gctrials.co.za   
Principal Investigator: M Gani, MD         
Setshaba Research Centre Recruiting
Pretoria, South Africa, 0152
Contact: M Malahleha, MD    + 27 (0) 12 799 2422    mookho@setshaba.org.za   
Principal Investigator: M Malahleha, MD         
Synexus Stanza Bopape Clinic Recruiting
Pretoria, South Africa, 0122
Contact: Boitumelo Sebopa, MD    + 27 (0) 12 812 0469    SBCRInv1@synexus-sa.co.za   
Principal Investigator: Boitumelo Sebopa, MD         
Sponsors and Collaborators
Statens Serum Institut
Investigators
Study Director: Pernille N Tingskov, BN, RN Statens Serum Institut
Principal Investigator: Keertan Dheda, MD, Prof UCT Lung Institute, University of Cape Town
  More Information

No publications provided

Responsible Party: Statens Serum Institut
ClinicalTrials.gov Identifier: NCT01779102     History of Changes
Other Study ID Numbers: TESEC-07
Study First Received: January 18, 2013
Last Updated: April 10, 2014
Health Authority: South Africa: Medicines Control Council

Additional relevant MeSH terms:
Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on April 15, 2014