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. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 18, 2014