Ignite Creation Date:
2025-12-24 @ 1:17 PM
Ignite Modification Date:
2025-12-29 @ 7:21 PM
Study NCT ID:
NCT00730795
Status:
COMPLETED
Last Update Posted:
2008-08-08
First Post:
2008-08-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Immunogenicity of a Candidate Tuberculosis (TB) Vaccine Given to PPD-Negative Adults
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': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-08', 'lastUpdateSubmitDate': '2008-08-07', 'studyFirstSubmitDate': '2008-08-07', 'studyFirstSubmitQcDate': '2008-08-07', 'lastUpdatePostDateStruct': {'date': '2008-08-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-08-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurrence of dose limiting toxicity', 'timeFrame': 'From study start up to Day 56.'}, {'measure': 'Occurrence of serious adverse events', 'timeFrame': 'During the entire study period.'}, {'measure': 'Occurrence of adverse events', 'timeFrame': 'At each visit'}, {'measure': 'Laboratory measurements of serum chemistry and hematology', 'timeFrame': 'At study start, prior to each vaccination and 1 and 6 months after dose 3'}, {'measure': 'Resting vital signs (blood pressure, pulse, temperature)', 'timeFrame': 'At study start, prior to each vaccination and 1 and 6 months after dose 3'}, {'measure': 'Chest X-ray findings', 'timeFrame': 'At study start and study end'}], 'secondaryOutcomes': [{'measure': 'Evaluation of T cell and antibody responses to the fusion protein and to each of the three Mycobacterium tuberculosis antigen domains.', 'timeFrame': 'Prior to each vaccination and 1 and 6 months after dose 3'}, {'measure': 'Evaluation of PPD skin reactivity', 'timeFrame': 'At study start and study end'}]}, 'conditionsModule': {'keywords': ['Tuberculosis vaccine'], 'conditions': ['Tuberculosis (TB)']}, 'referencesModule': {'references': [{'pmid': '19587528', 'type': 'DERIVED', 'citation': 'Von Eschen K, Morrison R, Braun M, Ofori-Anyinam O, De Kock E, Pavithran P, Koutsoukos M, Moris P, Cain D, Dubois MC, Cohen J, Ballou WR. The candidate tuberculosis vaccine Mtb72F/AS02A: Tolerability and immunogenicity in humans. Hum Vaccin. 2009 Jul;5(7):475-82. doi: 10.4161/hv.8570. Epub 2009 Jul 27.'}]}, 'descriptionModule': {'briefSummary': "This Phase I study will evaluate the safety and immunogenicity of two doses GSK Biologicals' candidate TB vaccine (692342) according to a 0, 1, 2 months schedule in PPD-negative adults."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy male or female between 18 and 40 years of age at the time of screening\n* Negative PPD skin test at screening.\n* Subjects must have chest X-ray showing no evidence of pulmonary pathology.\n* Female subjects of childbearing potential must have a negative serum pregnancy test at screening, must not be breast-feeding and are required to use adequate contraception from enrolment till 1 month after dose 3.\n* Screening laboratory values must be within the laboratory normal ranges.\n* Negative for human immunodeficiency virus-1 and 2 (HIV 1/2) antibody, hepatitis B surface antigen (HBsAg), and hepatitis C virus (HCV) antibody.\n* Subjects must give written informed consent.\n* Subjects must be willing to make all evaluation visits, be readily reachable by telephone or personal contact by the study site personnel and have a permanent address.\n* Subjects' resting seated vital signs must be within the protocol-defined ranges.\n\nExclusion Criteria:\n\n* History of prior Bacillus Calmette-Guérin (BCG) vaccinations.\n* History of documented exposure to Mycobacterium tuberculosis.\n* History of previous administration of experimental Mycobacterium tuberculosis vaccines or previous exposure to experimental products containing components of the experimental vaccine.\n* History of employment in a healthcare facility in a capacity that had direct or indirect contact with TB patients.\n* Administration of any immunoglobulins or any immunotherapy within the 3 months preceding the first dose of study vaccination, and/or any blood products within the 4 months preceding HIV screening, or planned administrations during the study period.\n* Use of St. John's Wort within six months of the Day 0 visit or planned administrations during the study period.\n* Participation in another experimental protocol and/or receipt of any investigational products within 30 days prior to Day 0.\n* History of autoimmune disease or causes of immunosuppressive states.\n* History of any acute or chronic illness or medication that, in the opinion of the Investigator, may interfere with the evaluation of the safety or immunogenicity of the vaccine.\n* History of significant psychiatric illness.\n* Current drug or alcohol abuse\n* History of previous anaphylaxis or severe allergic reaction to vaccines or any other allergen.\n* Subjects who are, in the opinion of the investigator, at significantly increased risk of non-cooperation with requirements of the study protocol.\n* Any chronic drug therapy to be continued during the study period, with the exception of vitamins and/or dietary supplements (including mineral preparations such as calcium carbonate), herbal medications except St. John's Wort, birth control pills, anti-histamines for seasonal allergies, SSRIs (e.g. Prozac, Zoloft, Paxil), NSAIDs (e.g. aspirin, ibuprofen), and acetominophen.\n* Chronic administration (defined as more than 14 days total) of immunosuppressants or other immune modifying drugs within six months prior to the first vaccine dose.\n* History of chronic or intermittently recurring illnesses such as migraine headaches, diabetes, heart disease, and asthma.\n* Current administration of anti-TB prophylaxis or therapy.\n* History of administration of a live attenuated virus vaccine within 30 days of enrollment.\n* History of administration of a subunit or killed vaccine within 14 days of enrollment."}, 'identificationModule': {'nctId': 'NCT00730795', 'briefTitle': 'Safety and Immunogenicity of a Candidate Tuberculosis (TB) Vaccine Given to PPD-Negative Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'A Phase I Open Label, Dose-Escalation Study to Evaluate the Safety and Immunogenicity of the Recombinant Mycobacterium Tuberculosis Vaccine, Mtb72F With AS02A Adjuvant, When Administered Intramuscularly to Healthy PPD-Negative Adults', 'orgStudyIdInfo': {'id': '692342/001'}, 'secondaryIdInfos': [{'id': 'CCTB001-01'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A', 'description': 'Subjects receiving the low-dose antigen candidate TB vaccine', 'interventionNames': ["Biological: GSK's candidate Mycobacterium tuberculosis vaccine 692342"]}, {'type': 'EXPERIMENTAL', 'label': 'Group B', 'description': 'Subjects receiving the high-dose antigen candidate TB vaccine', 'interventionNames': ["Biological: GSK's candidate Mycobacterium tuberculosis vaccine 692342"]}], 'interventions': [{'name': "GSK's candidate Mycobacterium tuberculosis vaccine 692342", 'type': 'BIOLOGICAL', 'description': 'Intramuscular injection, 3 doses at 0, 1, 2 months Different antigen doses (low and high)', 'armGroupLabels': ['Group A', 'Group B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9843', 'city': 'Tacoma', 'state': 'Washington', 'country': 'United States', 'facility': 'GSK Clinical Trials Call Center', 'geoPoint': {'lat': 47.25288, 'lon': -122.44429}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Corixa Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Isabelle Harpigny', 'oldOrganization': 'GSK Biologicals'}}}}