Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2025-12-26 @ 10:57 AM
Study NCT ID:
NCT04884308
Status:
COMPLETED
Last Update Posted:
2025-02-10
First Post:
2021-05-07
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Bacille Calmette-Guerin (BCG) Vaccine for Immune Protection Against Infections
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003550', 'term': 'Cystic Fibrosis'}, {'id': 'D001987', 'term': 'Bronchiectasis'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'nlechtz@jhmi.edu', 'phone': '410-502-7044', 'title': 'Noah Lechtzin', 'phoneExt': '4102994561', 'organization': 'Johns Hopkins University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '6 months', 'eventGroups': [{'id': 'EG000', 'title': 'Cystic Fibrosis', 'description': 'Participants with Cystic Fibrosis.\n\nBCG TICE Vaccine: Intradermal vaccination with BCG TICE', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 12, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Non Cystic Fibrosis Bronchiectasis', 'description': 'Participants with Non Cystic Fibrosis Bronchiectasis.\n\nBCG TICE Vaccine: Intradermal vaccination with BCG TICE', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 1, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Healthy Volunteer', 'description': 'Participants with no condition (healthy volunteers).\n\nBCG TICE Vaccine: Intradermal vaccination with BCG TICE', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 12, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'pustule', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'BCG Uptake', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cystic Fibrosis', 'description': 'Participants with Cystic Fibrosis.\n\nBCG TICE Vaccine: Intradermal vaccination with BCG TICE'}, {'id': 'OG001', 'title': 'Non Cystic Fibrosis Bronchiectasis', 'description': 'Participants with Non Cystic Fibrosis Bronchiectasis.\n\nBCG TICE Vaccine: Intradermal vaccination with BCG TICE'}, {'id': 'OG002', 'title': 'Healthy Volunteer', 'description': 'Participants with no condition (healthy volunteers).\n\nBCG TICE Vaccine: Intradermal vaccination with BCG TICE'}], 'classes': [{'categories': [{'measurements': [{'value': '48.06', 'spread': '23.52', 'groupId': 'OG000'}, {'value': '0.84', 'spread': '16.92', 'groupId': 'OG001'}, {'value': '35.97', 'spread': '23.64', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'description': 'Change in concentration of interferon (IFN) gamma levels in blood after Bacille Calmette-Guérin (BCG) incubation relative to baseline as measured by SFUs. Spot forming units (SFU) is a measure of immune response of mononuclear cells in response to M. avium lysate. Higher values indicate a stronger immune response.', 'unitOfMeasure': 'spot forming units', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyzed all participants enrolled'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cystic Fibrosis', 'description': 'Participants with Cystic Fibrosis.\n\nBCG TICE Vaccine: Intradermal vaccination with BCG TICE'}, {'id': 'FG001', 'title': 'Non Cystic Fibrosis Bronchiectasis', 'description': 'Participants with Non Cystic Fibrosis Bronchiectasis.\n\nBCG TICE Vaccine: Intradermal vaccination with BCG TICE'}, {'id': 'FG002', 'title': 'Healthy Volunteer', 'description': 'Participants with no condition (healthy volunteers).\n\nBCG TICE Vaccine: Intradermal vaccination with BCG TICE'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Cystic Fibrosis', 'description': 'Participants with Cystic Fibrosis.\n\nBCG TICE Vaccine: Intradermal vaccination with BCG TICE'}, {'id': 'BG001', 'title': 'Non Cystic Fibrosis Bronchiectasis', 'description': 'Participants with Non Cystic Fibrosis Bronchiectasis.\n\nBCG TICE Vaccine: Intradermal vaccination with BCG TICE'}, {'id': 'BG002', 'title': 'Healthy Volunteer', 'description': 'Participants with no condition (healthy volunteers).\n\nBCG TICE Vaccine: Intradermal vaccination with BCG TICE'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '32.4', 'spread': '13.5', 'groupId': 'BG000'}, {'value': '44.4', 'spread': '22.3', 'groupId': 'BG001'}, {'value': '35.8', 'spread': '10.2', 'groupId': 'BG002'}, {'value': '34.8', 'spread': '12.5', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'SFU count', 'classes': [{'categories': [{'measurements': [{'value': '35.22', 'spread': '35.18', 'groupId': 'BG000'}, {'value': '32.5', 'spread': '17.68', 'groupId': 'BG001'}, {'value': '38.75', 'spread': '48.14', 'groupId': 'BG002'}, {'value': '35.49', 'spread': '33.67', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Spot forming units (SFU) is a measure of immune response of mononuclear cells in response to M. avium lysate. Higher values indicate a stronger immune response.', 'unitOfMeasure': 'Spot forming units (SFU)', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Data is presented for all patients enrolled that received BCG vaccination (N=30)'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-12-21', 'size': 346565, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-01-16T15:39', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2023-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-16', 'studyFirstSubmitDate': '2021-05-07', 'resultsFirstSubmitDate': '2025-01-16', 'studyFirstSubmitQcDate': '2021-05-07', 'lastUpdatePostDateStruct': {'date': '2025-02-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-01-16', 'studyFirstPostDateStruct': {'date': '2021-05-12', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'BCG Uptake', 'timeFrame': '3 months', 'description': 'Change in concentration of interferon (IFN) gamma levels in blood after Bacille Calmette-Guérin (BCG) incubation relative to baseline as measured by SFUs. Spot forming units (SFU) is a measure of immune response of mononuclear cells in response to M. avium lysate. Higher values indicate a stronger immune response.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['BCG vaccine', 'Cystic fibrosis', 'Bronchiectasis', 'Non-tuberculosis mycobacteria'], 'conditions': ['Cystic Fibrosis', 'Bronchiectasis Adult', 'Non-Tuberculous Mycobacteria']}, 'descriptionModule': {'briefSummary': 'This is pilot study of the immunologic effects of intradermal Bacille Calmette-Guerin (BCG) vaccination of adults with cystic fibrosis (CF), non-CF bronchiectasis (NCFB), and healthy volunteers.', 'detailedDescription': 'This single-site, open-label clinical trial to investigate the immune effects of BCG vaccination in adults with cystic fibrosis, non-cystic fibrosis bronchiectasis and healthy volunteers by measuring pre and post vaccination immune responses, BCG uptake and protection against infections, including nontuberculous mycobacteria (NTM). This study will also gather data on study feasibility, tolerability, and safety.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria (CF and non-CF bronchiectasis):\n\n* Confirmed diagnosis of either CF or non-CF bronchiectasis\n* Forced expiratory volume over one second (FEV1) \\> 40%\n* Willingness to participate in the study after all aspects of the protocol have been explained and written informed consent obtained.\n* Available for the study duration, including all planned follow-up visits\n\nInclusion Criteria (Healthy Volunteers):\n\n* Negative HIV enzyme-linked immunosorbent assay (ELISA) and confirmatory test at screening.\n* Willingness to participate in the study after all aspects of the protocol have been explained and written informed obtained.\n* Available for the study duration, including all planned follow-up visits\n\nExclusion Criteria (All arms):\n\n* Current or prior history of active or latent tuberculosis (TB) (per report, not formally tested) or NTM infection\n* Prior BCG vaccination\n* Previous vaccine in the past 4 weeks\n* History of severe anaphylaxis to any vaccine or vaccine components\n* History of organ/bone marrow transplantation or other immunosuppressing condition, including HIV\n* Immunosuppressing drugs (including oral corticosteroids equivalent to \\>10mg of prednisone for 5 days) in the 30 days prior to study enrollment\n* Cirrhosis or portal hypertension\n* Pregnant or breastfeeding\n* Receipt of another investigational product in the last 28 days or planned receipt during this study\n* Has any other condition that, in the opinion of the principal investigator, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving study objectives.'}, 'identificationModule': {'nctId': 'NCT04884308', 'briefTitle': 'Bacille Calmette-Guerin (BCG) Vaccine for Immune Protection Against Infections', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'Effects of BCG Vaccine on the Immune System of Individuals With Cystic Fibrosis, Non-Cystic Fibrosis Bronchiectasis, and Healthy Volunteers', 'orgStudyIdInfo': {'id': 'IRB00256425'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cystic Fibrosis', 'description': 'Participants with Cystic Fibrosis.', 'interventionNames': ['Biological: BCG TICE Vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'Non Cystic Fibrosis Bronchiectasis', 'description': 'Participants with Non Cystic Fibrosis Bronchiectasis.', 'interventionNames': ['Biological: BCG TICE Vaccine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Healthy Volunteer', 'description': 'Participants with no condition (healthy volunteers).', 'interventionNames': ['Biological: BCG TICE Vaccine']}], 'interventions': [{'name': 'BCG TICE Vaccine', 'type': 'BIOLOGICAL', 'description': 'Intradermal vaccination with BCG TICE', 'armGroupLabels': ['Cystic Fibrosis', 'Healthy Volunteer', 'Non Cystic Fibrosis Bronchiectasis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Noah Lecthzin, MD, MHS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cystic Fibrosis Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}