Ignite Creation Date:
2025-12-25 @ 1:21 AM
Ignite Modification Date:
2026-03-16 @ 10:15 PM
Study NCT ID:
NCT01003093
Status:
COMPLETED
Last Update Posted:
2013-01-21
First Post:
2009-10-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Safety and Immunogenicity Trial With an Adjuvanted Tuberculosis(TB) Subunit Vaccine
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': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-18', 'studyFirstSubmitDate': '2009-10-27', 'studyFirstSubmitQcDate': '2009-10-27', 'lastUpdatePostDateStruct': {'date': '2013-01-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-10-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Physical examination. Local adverse events. Systemic adverse events. Laboratory safety tests including urine safety tests.', 'timeFrame': 'From the first vaccination until 8 months after the first vaccination'}], 'secondaryOutcomes': [{'measure': 'Detection by ELISPOT of IFN gamma spot-forming cells in PBMC. Detection by ELISA of IFN gamma production in supernatants of PBMC. Detection of humoral response (IgG) by ELISA.', 'timeFrame': 'From first vaccination until 36 months after first vaccination'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Tuberculosis', 'Vaccine', 'Ag85B', 'ESAT-6', 'IC31'], 'conditions': ['Tuberculosis']}, 'referencesModule': {'references': [{'pmid': '21178394', 'type': 'DERIVED', 'citation': 'Ottenhoff TH, Doherty TM, van Dissel JT, Bang P, Lingnau K, Kromann I, Andersen P. First in humans: a new molecularly defined vaccine shows excellent safety and strong induction of long-lived Mycobacterium tuberculosis-specific Th1-cell like responses. Hum Vaccin. 2010 Dec;6(12):1007-15. doi: 10.4161/hv.6.12.13143. Epub 2010 Dec 1.'}, {'pmid': '20226890', 'type': 'DERIVED', 'citation': 'van Dissel JT, Arend SM, Prins C, Bang P, Tingskov PN, Lingnau K, Nouta J, Klein MR, Rosenkrands I, Ottenhoff TH, Kromann I, Doherty TM, Andersen P. Ag85B-ESAT-6 adjuvanted with IC31 promotes strong and long-lived Mycobacterium tuberculosis specific T cell responses in naive human volunteers. Vaccine. 2010 Apr 30;28(20):3571-81. doi: 10.1016/j.vaccine.2010.02.094. Epub 2010 Mar 11.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety profile of an adjuvanted TB subunit vaccine administered at 0 and 2 months in healthy BCG-unvaccinated volunteers with no prior history of TB disease or known prior exposure to TB'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male\n* Healthy based on medical examination/history at the inclusion\n* Age between 18 and 55 years\n* Signed informed consent\n* Prepared to grant authorized persons access to the medical records\n* The volunteer is likely to comply with instructions\n\nExclusion Criteria:\n\n* Known exposure to TB before (or expected during) the trial\n* Prior BCG vaccination\n* Granulomatous disease (by chest X-ray, autoimmune screen)\n* Vaccinated with live vaccine 3 months before first vaccination\n* Administration of immune modulating drugs (steroids, immunosuppressive drugs or immunoglobulins) 3 months before the first vaccination\n* HBV, HCV or HIV sero-positive (HBsAg, HBsAb, HBc total and IgM ab and HCV, HIV-1 and HIV2 ab)\n* Participation in other clinical trials\n* Positive Mantoux or QuantiFERON-TB Gold\n* Known hypersensitivity to any of the vaccine components\n* Laboratory parameters outside of normal ranges considered clinically relevant'}, 'identificationModule': {'nctId': 'NCT01003093', 'acronym': 'THYB-01', 'briefTitle': 'A Safety and Immunogenicity Trial With an Adjuvanted Tuberculosis(TB) Subunit Vaccine', 'organization': {'class': 'OTHER', 'fullName': 'Statens Serum Institut'}, 'officialTitle': 'A Safety and Immunogenicity Phase 1 Trial With an Adjuvanted TB Subunit Vaccine (Ag85B-ESAT-6 + IC31) Administered at 0 and 2 Months', 'orgStudyIdInfo': {'id': 'THYB-01'}, 'secondaryIdInfos': [{'id': 'Eudract number: TEST-001599-14'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Antigen group + high adjuvans', 'description': 'The antigen group + high adjuvans group received two injections of antigen (Ag85B + ESAT-6) + IC31 (500 nmol KLK + 20 nmol ODN1a) two months apart.', 'interventionNames': ['Biological: 50 microgram antigen (Ag85B + ESAT-6) + 500 nmol KLK + 20 nmol ODN1a']}, {'type': 'EXPERIMENTAL', 'label': 'Antigen group', 'description': 'The antigen group received two injections of antigen (Ag85B + ESAT-6) two months apart.', 'interventionNames': ['Biological: 50 microgram antigen (Ag85B + ESAT-6)']}, {'type': 'EXPERIMENTAL', 'label': 'Antigen + low adjuvans group', 'description': 'The antigen group + low adjuvans group received two injections of antigen (Ag85B + ESAT-6) + IC31 (100 nmol KLK + 4 nmol ODN1a) two months apart.', 'interventionNames': ['Biological: 50 microgram antigen (Ag85B + ESAT-6) + 100 nmol KLK + 4 nmol ODN1a']}], 'interventions': [{'name': '50 microgram antigen (Ag85B + ESAT-6)', 'type': 'BIOLOGICAL', 'otherNames': ['Antigen H1'], 'description': '0.5 mL suspension for injection x 2 with 2 months interval', 'armGroupLabels': ['Antigen group']}, {'name': '50 microgram antigen (Ag85B + ESAT-6) + 100 nmol KLK + 4 nmol ODN1a', 'type': 'BIOLOGICAL', 'otherNames': ['Antigen H1 + IC31'], 'description': '0.5 mL suspension for injection x 2 with 2 months interval', 'armGroupLabels': ['Antigen + low adjuvans group']}, {'name': '50 microgram antigen (Ag85B + ESAT-6) + 500 nmol KLK + 20 nmol ODN1a', 'type': 'BIOLOGICAL', 'otherNames': ['Antigen H1 + IC31'], 'description': '0.5 mL suspension for injection x 2 with 2 months interval', 'armGroupLabels': ['Antigen group + high adjuvans']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2300', 'city': 'Leiden', 'state': 'RC Leiden', 'country': 'Netherlands', 'facility': 'Leiden University Medical Centre', 'geoPoint': {'lat': 52.15833, 'lon': 4.49306}}], 'overallOfficials': [{'name': 'Jaap van Dissel, MD, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Leiden University Medical Centre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Statens Serum Institut', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}