Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2025-12-30 @ 10:00 PM
Study NCT ID:
NCT01375933
Status:
COMPLETED
Last Update Posted:
2012-05-14
First Post:
2011-06-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Comparability Study of the Phase 3 Lot and a Single Commercial Lot of NicVAX in Healthy Adult Smokers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012907', 'term': 'Smoking'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 260}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'completionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-05-10', 'studyFirstSubmitDate': '2011-06-15', 'studyFirstSubmitQcDate': '2011-06-17', 'lastUpdatePostDateStruct': {'date': '2012-05-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Immunogenicity', 'timeFrame': 'At Week 14', 'description': 'To compare imunogenicity of two lots by serum antibody concentration'}], 'secondaryOutcomes': [{'measure': 'Safety', 'timeFrame': 'Through Week 16', 'description': 'Assess safety by adverse events reported'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Smoking', 'NicVAX', 'Smoking vaccine'], 'conditions': ['Smoking']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the comparability of the phase 3 lot and a single commercial lot of NicVAX in healthy smokers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male or female smokers, age 18-55, who are currently smoking at least 10 cigarettes per day.\n\nExclusion Criteria:\n\n* Prior exposure to NicVAX or any other nicotine vaccine.\n* History of clinically significant allergic reactions.\n* Use of systemic steroids.\n* Cancer or cancer treatment within 5 years.\n* HIV infection.\n* History of drug or alcohol abuse or dependence.\n* Required treatment for depression within the past 12 months.\n* Body mass index ≥ 30 \\[calculated as weight (kg)/height2 (m)\\].\n* Significant cardiovascular, hepatic, renal, psychiatric and/or respiratory disease.\n* Inability to fulfill all visits for approximately 30 weeks.'}, 'identificationModule': {'nctId': 'NCT01375933', 'briefTitle': 'A Comparability Study of the Phase 3 Lot and a Single Commercial Lot of NicVAX in Healthy Adult Smokers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nabi Biopharmaceuticals'}, 'officialTitle': "A Phase 3, Multicenter, Double-Blinded, Randomized, Study to Assess Comparability of a Single Phase 3 Lot and a Single Commercial Lot of 3'-Aminomethylnicotine-P. Aeruginosa r-Exoprotein A Conjugate Vaccine (NicVAX) in Healthy Adult Smokers", 'orgStudyIdInfo': {'id': 'Nabi-4516'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'NicVAX - Phase 3 Lot', 'description': 'NicVAX - Phase 3 Lot', 'interventionNames': ['Biological: NicVAX Vaccine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'NicVAX - Commercial Lot', 'description': 'NicVAX - Commercial Lot', 'interventionNames': ['Biological: NicVAX Vaccine']}], 'interventions': [{'name': 'NicVAX Vaccine', 'type': 'BIOLOGICAL', 'description': 'NicVAX Vaccine given 6 times over 6 months', 'armGroupLabels': ['NicVAX - Commercial Lot', 'NicVAX - Phase 3 Lot']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35802', 'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': 'NicVAX Investigator', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '92018', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'NicVAX Investigator', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '32935', 'city': 'Melbourne', 'state': 'Florida', 'country': 'United States', 'facility': 'NicVAX Investigator', 'geoPoint': {'lat': 28.08363, 'lon': -80.60811}}, {'zip': '61602', 'city': 'Peoria', 'state': 'Illinois', 'country': 'United States', 'facility': 'NicVAX Investigator', 'geoPoint': {'lat': 40.69365, 'lon': -89.58899}}, {'zip': '46601', 'city': 'South Bend', 'state': 'Indiana', 'country': 'United States', 'facility': 'NicVAX Investigator', 'geoPoint': {'lat': 41.68338, 'lon': -86.25001}}, {'zip': '20850', 'city': 'Rockville', 'state': 'Maryland', 'country': 'United States', 'facility': 'NicVAX Investigator', 'geoPoint': {'lat': 39.084, 'lon': -77.15276}}], 'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Nabi Biopharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nabi Biopharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}