Ignite Creation Date:
2025-12-24 @ 5:44 PM
Ignite Modification Date:
2025-12-29 @ 2:38 AM
Study NCT ID:
NCT05203068
Status:
COMPLETED
Last Update Posted:
2023-08-25
First Post:
2022-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Specificity Trial of the Recombinant Tuberculosis Allergen in BCG Vaccinated Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'alexeykazakov1982@yandex.ru', 'phone': '+79254666638', 'title': 'Dr. Kazakov Aleksey Vladimirovich, principal investigator', 'organization': 'Federal State Budgetary Institution "National Medical Research Center of Phthisiopulmonology and Infectious Diseases" of the Ministry of Health of the Russian Federation'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '28 days', 'eventGroups': [{'id': 'EG000', 'title': 'Recombinant Tuberculosis Allergen (CFP10-ESAT6)', 'description': 'RTA (CFP10-ESAT6) 0.2 µg/0.1 mL RTA given intradermally on the middle of the forearm\n\nRecombinant tuberculosis allergen (RTA): Single intradermal application of 0.2 µg/0.1 mL RTA (CFP10-ESAT6) in the middle of the forearm', 'otherNumAtRisk': 150, 'deathsNumAtRisk': 150, 'otherNumAffected': 1, 'seriousNumAtRisk': 150, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of the Volunteers With the True Negative RTA Result', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Recombinant Tuberculosis Allergen (CFP10-ESAT6)', 'description': 'RTA (CFP10-ESAT6) 0.2 µg/0.1 mL RTA given intradermally on the middle of the forearm\n\nRecombinant tuberculosis allergen (RTA): Single intradermal application of 0.2 µg/0.1 mL RTA (CFP10-ESAT6) in the middle of the forearm'}], 'classes': [{'title': 'Count RTA negative', 'categories': [{'measurements': [{'value': '145', 'groupId': 'OG000'}]}]}, {'title': 'Count RTA positive', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'hour 72', 'description': 'Absolute number and percentage of the volunteers with negative and positive test results with RTA based on the results of the assessment of the infiltrate 72 hours after the test application', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Local Adverse Reactions Within 72 Hours Following the Intradermal Test Application', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Recombinant Tuberculosis Allergen (CFP10-ESAT6)', 'description': 'RTA (CFP10-ESAT6) 0.2 µg/0.1 mL RTA given intradermally on the middle of the forearm\n\nRecombinant tuberculosis allergen (RTA): Single intradermal application of 0.2 µg/0.1 mL RTA (CFP10-ESAT6) in the middle of the forearm'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'hour 72', 'description': 'To assess the number of subjects who developed the injection site adverse reaction (redness, swelling etc) within 72 hours after RTA test application', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With General and Local Adverse Reactions Within 28 Days After Administration of RTA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Recombinant Tuberculosis Allergen (CFP10-ESAT6)', 'description': 'RTA (CFP10-ESAT6) 0.2 µg/0.1 mL RTA given intradermally on the middle of the forearm\n\nRecombinant tuberculosis allergen (RTA): Single intradermal application of 0.2 µg/0.1 mL RTA (CFP10-ESAT6) in the middle of the forearm'}], 'classes': [{'categories': [{'title': 'Number of participants developed general adverse reaction in 28 days after RTA application', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Number of participants developed local adverse reactions in 28 days after RTA application', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Number of participants without adverse reactions in 28 days after RTA application', 'measurements': [{'value': '149', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 28', 'description': 'To assess the number of subjects who developed the general adverse reaction (e.g. infections, fever, headache, weakness etc) based on the subjects complaints and physical examination, and local injection site reaction (redness, swelling etc) up to 28 days after intradermal RTA application.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Recombinant Tuberculosis Allergen (CFP10-ESAT6)', 'description': 'RTA (CFP10-ESAT6) 0.2 µg/0.1 mL RTA given intradermally on the middle of the forearm\n\nRecombinant tuberculosis allergen (RTA): Single intradermal application of 0.2 µg/0.1 mL RTA (CFP10-ESAT6) in the middle of the forearm'}], 'periods': [{'title': 'RTA Result Assessment, 72 Hours', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '150'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '150'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': 'RTA Safety Assessment, 28 Days', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '150'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '150'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Recombinant Tuberculosis Allergen (CFP10-ESAT6)', 'description': 'RTA (CFP10-ESAT6) 0.2 µg/0.1 mL RTA given intradermally on the middle of the forearm\n\nRecombinant tuberculosis allergen (RTA): Single intradermal application of 0.2 µg/0.1 mL RTA (CFP10-ESAT6) in the middle of the forearm'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '21.5', 'groupId': 'BG000', 'lowerLimit': '20', 'upperLimit': '22'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '122', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '28', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Russia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '150', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body weight', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000', 'lowerLimit': '55', 'upperLimit': '69'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilograms', 'dispersionType': 'FULL_RANGE'}, {'title': 'BCG-vaccination history', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '150', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Having allergic diseases in the past', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '148', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Having chronic diseases', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'COVID-19 vaccinated', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '145', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': '150 healthy adult subjects'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-11-22', 'size': 372126, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-10-11T03:59', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2022-01-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-11', 'studyFirstSubmitDate': '2022-01-09', 'resultsFirstSubmitDate': '2022-01-27', 'studyFirstSubmitQcDate': '2022-01-21', 'lastUpdatePostDateStruct': {'date': '2023-08-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-10-11', 'studyFirstPostDateStruct': {'date': '2022-01-24', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-08-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of the Volunteers With the True Negative RTA Result', 'timeFrame': 'hour 72', 'description': 'Absolute number and percentage of the volunteers with negative and positive test results with RTA based on the results of the assessment of the infiltrate 72 hours after the test application'}], 'secondaryOutcomes': [{'measure': 'Number of Subjects With Local Adverse Reactions Within 72 Hours Following the Intradermal Test Application', 'timeFrame': 'hour 72', 'description': 'To assess the number of subjects who developed the injection site adverse reaction (redness, swelling etc) within 72 hours after RTA test application'}, {'measure': 'Number of Participants With General and Local Adverse Reactions Within 28 Days After Administration of RTA', 'timeFrame': 'Day 28', 'description': 'To assess the number of subjects who developed the general adverse reaction (e.g. infections, fever, headache, weakness etc) based on the subjects complaints and physical examination, and local injection site reaction (redness, swelling etc) up to 28 days after intradermal RTA application.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tuberculosis', 'TB diagnosis', 'Tuberculosis skin test', 'CFP10', 'ESAT6'], 'conditions': ['Tuberculosis']}, 'referencesModule': {'references': [{'pmid': '36936243', 'type': 'DERIVED', 'citation': 'Vasilyeva IA, Aksenova VA, Kazakov AV, Kiseleva YY, Maryandyshev AO, Dolzhenko EN, Abramchenko AV, Klevno NI, Glebov KA, Panova AE, Petrova LY, Sheikis EG, Seregina IV, Nikishova EI, Doktorova NP, Samoilova AG. Evaluation of the specificity of an intradermal test with recombinant tuberculosis allergen in Bacillus Calmette-Guerin-vaccinated healthy volunteers. Front Med (Lausanne). 2023 Mar 1;10:1042461. doi: 10.3389/fmed.2023.1042461. eCollection 2023.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to test the recombinant tuberculosis skin test in the previously BCG vaccinated healthy adults with low risk of TB development, to determine the test specificity.', 'detailedDescription': 'Recombinant tuberculosis allergen (RTA) is a recombinant fusion protein CFP10-ESAT6 produced by the prokaryotic cell line. The test is widely used in Russian Federation and CIS countries for the latent TB diagnosis in adults and children over 8 years old. The current clinical study is a prospective, multicenter, open-label study in the cohort of healthy adults, not classified as at risk of tuberculosis, with no clinical symptoms of the disease, with a negative T-SPOT.TB test results, to evaluate the specificity of the RTA test in 72 hours following administration of the product at a dose of 0.2 μg/0.1 mL.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Signed informed consent for the participation in the study.\n2. Age 18 to 30 years\n3. A history of BCG vaccination (confirmed by medical documentation and/or the presence of BCG scar)\n4. Healthy individual according to physical examination and medical records at screening.\n5. Willingness to cooperate and follow the recommendations of the Investigator in accordance with the Protocol.\n\nExclusion Criteria:\n\n1. A history of tuberculosis or close contact with a patient with active tuberculosis for 5 years prior to the enrollment in the study.\n2. Positive T-SPOT.TB test at the enrollment in the study\n3. Treatment with drugs affecting immune system within 3 months prior to the enrollment in the study\n4. Vaccination against any infections \\<1.5 months prior to the enrollment in the study\n5. Vaccination with BCG \\<6 months prior to the enrollment in the study.\n6. The Mantoux test with 2 TU and/or the test with the recombinant tuberculosis allergen was performed less than 6 months prior to the enrollment in the study.\n7. Congenital or acquired immunodeficiency.\n8. Active disease of the immune system\n9. HIV infection.\n10. The current condition of the skin interferes with the conduct and reading of skin tests (trauma, skin diseases).\n11. A disease in which blood sampling poses a risk to the volunteer (hemophilia, other bleeding disorders) or obstructed venous access.\n12. The volunteer currently participates in another clinical study or has participated in another clinical study within 3 months prior to the enrollment in the study.\n13. Previous participation in clinical studies of ESAT-6 and/or CFP-10 antigens.\n14. Pregnancy, lactation, pregnancy planning.\n15. The reluctance of a female person to use effective barrier (including spermicidal gel), hormonal or intrauterine contraceptives during the study.\n16. History of alcohol, drug, benzodiazepine, or other substance abuse within the 12 months prior to the enrollment in the study.\n17. Use of alcoholic beverages within 24 hours prior to the visit.\n18. A condition or disease that, in the opinion of the Investigator, is inappropriate for participation in the study.'}, 'identificationModule': {'nctId': 'NCT05203068', 'briefTitle': 'Specificity Trial of the Recombinant Tuberculosis Allergen in BCG Vaccinated Healthy Volunteers', 'organization': {'class': 'OTHER_GOV', 'fullName': 'National Medical Research Center of Phthisiopulmonology and Infectious Diseases'}, 'officialTitle': 'Evaluation of the Specificity of Intradermal Test With Recombinant Tuberculosis Allergen in BCG Vaccinated Healthy Volunteers', 'orgStudyIdInfo': {'id': '102/1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Recombinant tuberculosis allergen (CFP10-ESAT6)', 'description': 'RTA (CFP10-ESAT6) 0.2 µg/0.1 mL RTA given intradermally on the middle of the forearm', 'interventionNames': ['Diagnostic Test: Recombinant tuberculosis allergen (RTA)']}], 'interventions': [{'name': 'Recombinant tuberculosis allergen (RTA)', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Diaskintest'], 'description': 'Single intradermal application of 0.2 µg/0.1 mL RTA (CFP10-ESAT6) in the middle of the forearm', 'armGroupLabels': ['Recombinant tuberculosis allergen (CFP10-ESAT6)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Moscow', 'country': 'Russia', 'facility': 'National Medical Research Center of Phthisiopulmonology and Infectious Diseases', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}], 'overallOfficials': [{'name': 'Aleksey V. Kazakov, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Medical Research Center of Phthisiopulmonology and Infectious Diseases'}, {'name': 'Anastasia G. Samoylova, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'National Medical Research Center of Phthisiopulmonologyand Infectious Diseases'}, {'name': 'Valentina A. Aksyonova, Prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'National Medical Research Center of Phtisiopulmonology and Infectious Diseases'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Medical Research Center of Phthisiopulmonology and Infectious Diseases', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}