Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2026-01-13 @ 5:51 PM
Study NCT ID:
NCT01779102
Status:
COMPLETED
Last Update Posted:
2015-04-17
First Post:
2013-01-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety Study Investigating if Concomitant Injections of C-Tb and 2 T.U Tuberculin Affect Induration Responses
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014376', 'term': 'Tuberculosis'}], 'ancestors': [{'id': 'D009164', 'term': 'Mycobacterium Infections'}, {'id': 'D000193', 'term': 'Actinomycetales Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 456}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-16', 'studyFirstSubmitDate': '2013-01-18', 'studyFirstSubmitQcDate': '2013-01-29', 'lastUpdatePostDateStruct': {'date': '2015-04-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-01-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '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)', 'timeFrame': 'Onset from the injection(s) to 28 days after the injections'}, {'measure': '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', 'timeFrame': 'Onset from the injection(s) to 28 days after the injections'}], 'secondaryOutcomes': [{'measure': "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", 'timeFrame': 'Onset from the injection(s) to 28 days after the injections'}, {'measure': "To compare the C-Tb test's ability to identify positive results in Tuberculosis infected patients with the PPD RT 23 test", 'timeFrame': 'Onset from the injection(s) to 28 days after the injections'}, {'measure': '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', 'timeFrame': 'Onset from the injection(s) to 28 days after the injections'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Tuberculosis']}, 'referencesModule': {'references': [{'pmid': '30572979', 'type': 'DERIVED', 'citation': 'Aggerbeck H, Ruhwald M, Hoff ST, Tingskov PN, Hellstrom E, Malahleha M, Siebert M, Gani M, Diacon A, Novelijc Z, Andersen P, Dheda K. Interaction between C-Tb and PPD given concomitantly in a split-body randomised controlled trial. Int J Tuberc Lung Dis. 2019 Jan 1;23(1):38-44. doi: 10.5588/ijtld.18.0137. Epub 2018 Dec 20.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.', 'detailedDescription': '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.\n\n* 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.\n* A group of 150 TB patients will only receive the C-Tb agent randomised to either RIGHT or LEFT forearm.\n* A group of 150 TB patients will only receive the reference agent PPD RT 23 randomised to either RIGHT or LEFT forearm.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria (HIV Negative patients):\n\n* Has signed an informed consent\n* Aged 18 to 65 years\n* Has been diagnosed with active pulmonary TB:\n\n 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\n 2. has a compatible clinical picture of TB according to South African Guidelines with the intention to treat and 1 documented positive GeneXpert analysis\n* Is HIV negative confirmed by 2 two rapid tests\n* Is willing and likely to comply with the trial procedures\n* Is prepared to grant authorized persons access to their medical record\n\nInclusion Criteria (HIV Positive patients):\n\n* Has signed an informed consent\n* Aged 18-65 years\n* Has been diagnosed with active pulmonary TB:\n\n 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\n 2. has a compatible clinical picture of TB according to South African Guidelines with the intention to treat and 1 documented positive GeneXpert analysis\n* Is HIV positive confirmed by:\n\n 1. 2 positive rapid tests or\n 2. 1 positive rapid tests and an additional confirmatory ELISA\n* A CD4 count has been performed\n* Is willing and likely to comply with the trial procedures\n* Is prepared to grant authorized persons access to their medical records\n\nExclusion Criteria:\n\n* Has been in treatment for TB for more than 2 weeks\n* Has a known MDR/XDR-TB\n* 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\n* Has been tuberculin (TST) tested \\< 12 months prior to the day of inclusion\n* Is pregnant, breastfeeding or intending to get pregnant\n* 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\n* Has an active disease affecting the lymphoid organs except for HIV (e.g., Hodgkin's disease, lymphoma, leukaemia, sarcoidosis)\n* 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\n* 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\n* 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\n* Has participated in previous clinical trials investigating the ESAT-6 and/or CFP-10 antigens\n* Has a condition which in the opinion of the investigator is not suitable for participation in the study"}, 'identificationModule': {'nctId': 'NCT01779102', 'acronym': 'TESEC-07', 'briefTitle': 'Safety Study Investigating if Concomitant Injections of C-Tb and 2 T.U Tuberculin Affect Induration Responses', 'organization': {'class': 'OTHER', 'fullName': 'Statens Serum Institut'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'TESEC-07'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '0.1 µg C-Tb', 'description': 'The C-Tb agent is given alone to volunteers in the RIGHT or LEFT forearm according to a double blind randomisation scheme', 'interventionNames': ['Biological: C-Tb']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2 T.U Tuberculin PPD RT 23 SSI', 'description': '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', 'interventionNames': ['Biological: Tuberculin PPD RT 23 SSI']}, {'type': 'EXPERIMENTAL', 'label': '0.1 µg C-Tb / 2 T.U Tuberculin PPD', 'description': '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', 'interventionNames': ['Biological: C-Tb / Tuberculin PPD RT 23 SSI']}], 'interventions': [{'name': 'C-Tb', 'type': 'BIOLOGICAL', 'description': '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', 'armGroupLabels': ['0.1 µg C-Tb']}, {'name': 'Tuberculin PPD RT 23 SSI', 'type': 'BIOLOGICAL', 'description': 'Tuberculin is administered by the Mantoux injection technique to each volunteer in the RIGHT or LEFT forearm according to a double blind randomisation scheme', 'armGroupLabels': ['2 T.U Tuberculin PPD RT 23 SSI']}, {'name': 'C-Tb / Tuberculin PPD RT 23 SSI', 'type': 'BIOLOGICAL', 'description': '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', 'armGroupLabels': ['0.1 µg C-Tb / 2 T.U Tuberculin PPD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7530', 'city': 'Cape Town', 'state': 'Cape Town', 'country': 'South Africa', 'facility': 'TASK, M2, Karl Bremer Hospital,', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}, {'zip': '7530', 'city': 'Cape Town', 'state': 'Cape Town', 'country': 'South Africa', 'facility': 'Tiervlei Trial Centre, Karl Bremer Hospital', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}, {'zip': '7925', 'city': 'Cape Town', 'state': 'Cape Town', 'country': 'South Africa', 'facility': 'UCT Lung Institute', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}, {'zip': '6014', 'city': 'Port Elizabeth', 'state': 'Port Elizabeth', 'country': 'South Africa', 'facility': 'Primecure Medicentre', 'geoPoint': {'lat': -33.96109, 'lon': 25.61494}}, {'zip': '0122', 'city': 'Pretoria', 'state': 'Pretoria', 'country': 'South Africa', 'facility': 'Synexus Stanza Bopape Clinic', 'geoPoint': {'lat': -25.74486, 'lon': 28.18783}}, {'zip': '0152', 'city': 'Pretoria', 'state': 'Pretoria', 'country': 'South Africa', 'facility': 'Setshaba Research Centre', 'geoPoint': {'lat': -25.74486, 'lon': 28.18783}}, {'zip': '7626', 'city': 'Paarl', 'state': 'Western Cape', 'country': 'South Africa', 'facility': 'Be Part Yoluntu Centre', 'geoPoint': {'lat': -33.73378, 'lon': 18.97523}}], 'overallOfficials': [{'name': 'Pernille N Tingskov, BN, RN', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Statens Serum Institut'}, {'name': 'Keertan Dheda, MD, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UCT Lung Institute, University of Cape Town'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Statens Serum Institut', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}