Safety Study Investigating if Concomitant Injections of C-Tb and 2 T.U Tuberculin Affect Induration Responses - Full Text View

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:

MedlinePlus related topics: Tuberculosis

Drug Information available for: Tuberculin Purified Protein Derivative

U.S. FDA Resources

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:	February 2013
Estimated Study Completion Date:	October 2013
Estimated Primary Completion Date:	October 2013 (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	Not yet 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	Not yet recruiting
Benoni, South Africa, 1501
Contact: I Mitha, MD + 27 (0) 11 422 1928 drmitha@iafrica.com
Principal Investigator: I Mitha, MD
TASK, M2, Karl Bremer Hospital,	Not yet 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	Not yet 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	Not yet 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
Port Elizabeth, South Africa, 6014
Setshaba Research Centre	Not yet 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	Not yet 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:	January 29, 2013
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 May 19, 2013

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