Ignite Creation Date:
2025-12-25 @ 2:48 AM
Ignite Modification Date:
2026-03-11 @ 1:02 AM
Study NCT ID:
NCT00995033
Status:
COMPLETED
Last Update Posted:
2013-02-20
First Post:
2009-10-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of NicVAX® Co-administered With Varenicline (Champix®)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012907', 'term': 'Smoking'}, {'id': 'D016540', 'term': 'Smoking Cessation'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D015438', 'term': 'Health Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068580', 'term': 'Varenicline'}], 'ancestors': [{'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011810', 'term': 'Quinoxalines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 558}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-18', 'studyFirstSubmitDate': '2009-10-06', 'studyFirstSubmitQcDate': '2009-10-12', 'lastUpdatePostDateStruct': {'date': '2013-02-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-10-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Long term abstinence', 'timeFrame': 'one year'}], 'secondaryOutcomes': [{'measure': 'Safety, immunogenicity', 'timeFrame': 'continuous assessment throughout the one year study duration'}, {'measure': 'Abstinence', 'timeFrame': 'continuous assessment throughout the one year study duration'}, {'measure': 'Lapse and relapse rate', 'timeFrame': 'continuous assessment throughout the one year study duration'}, {'measure': 'Withdrawal symptoms', 'timeFrame': 'continuous assessment throughout the one year study duration'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Smoking cessation', 'Smoking lapse behavior', 'Smoking Relapse behavior', 'Varenicline', 'Nicotine conjugate vaccine', 'Medication effect on smoking lapse behavior'], 'conditions': ['Smoking Behavior', 'Smoking Lapse Behavior', 'Smoking Relapse Behavior']}, 'referencesModule': {'references': [{'pmid': '37142273', 'type': 'DERIVED', 'citation': 'Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8.'}, {'pmid': '24894625', 'type': 'DERIVED', 'citation': "Hoogsteder PH, Kotz D, van Spiegel PI, Viechtbauer W, van Schayck OC. Efficacy of the nicotine vaccine 3'-AmNic-rEPA (NicVAX) co-administered with varenicline and counselling for smoking cessation: a randomized placebo-controlled trial. Addiction. 2014 Aug;109(8):1252-9. doi: 10.1111/add.12573. Epub 2014 Jun 3."}, {'pmid': '23216646', 'type': 'DERIVED', 'citation': 'Hoogsteder PH, Kotz D, van Spiegel PI, Viechtbauer W, Brauer R, Kessler PD, Kalnik MW, Fahim RE, van Schayck OC. The efficacy and safety of a nicotine conjugate vaccine (NicVAX(R)) or placebo co-administered with varenicline (Champix(R)) for smoking cessation: study protocol of a phase IIb, double blind, randomized, placebo controlled trial. BMC Public Health. 2012 Dec 6;12:1052. doi: 10.1186/1471-2458-12-1052.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety of NicVAX co-administered with varenicline as an aid in smoking cessation over a one-year period in smokers who want to quit smoking.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Smokes at least 10 cigarettes per day\n* Good general health\n* Negative pregnancy test prior to study entry\n\nExclusion Criteria:\n\n* Prior exposure to NicVAX or any other nicotine vaccine\n* Known allergic reaction to alum or any of the components of the vaccine\n* Use of systemic steroids, immunosuppressive agents or other medication that might interfere with an immune response\n* Cancer or cancer treatment in the last 5 years\n* HIV infection\n* History of drug or alcohol abuse or dependence within 12 months\n* Significant cardiovascular, hepatic, renal, psychiatric and/or respiratory disease\n* Previous intolerance to varenicline\n* Inability to fulfill all visits for approximately 54 weeks'}, 'identificationModule': {'nctId': 'NCT00995033', 'briefTitle': 'Efficacy and Safety of NicVAX® Co-administered With Varenicline (Champix®)', 'organization': {'class': 'OTHER', 'fullName': 'Maastricht University Medical Center'}, 'officialTitle': "A Phase 2B, Multi-Center, Randomized, Double-Blinded, Parallel-Arm , Study to Assess Efficacy and Safety of 3'-Aminomethylnicotine-P. Aeruginosa r-Exoprotein A Conjugate Vaccine (NicVAX®) or Placebo Co-Administered With Varenicline (Champix®) as an Aid in Smoking Cessation", 'orgStudyIdInfo': {'id': 'MEC 08-5-066'}, 'secondaryIdInfos': [{'id': 'ZonMw 40-00812-98-07-004'}, {'id': 'ZonMw 61200014'}, {'id': 'Nabi-4508'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NicVAX conjugate vaccine', 'interventionNames': ['Biological: NicVAX vaccine', 'Drug: Varenicline']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Biological', 'interventionNames': ['Biological: Placebo', 'Drug: Varenicline']}], 'interventions': [{'name': 'NicVAX vaccine', 'type': 'BIOLOGICAL', 'description': 'NicVAX vaccine given 6 times over 6 months', 'armGroupLabels': ['NicVAX conjugate vaccine']}, {'name': 'Placebo', 'type': 'BIOLOGICAL', 'description': 'Phosphate buffered saline and ALhydrogel of identical appearance to NicVAX; IM in 6 doses over 6 months', 'armGroupLabels': ['Placebo']}, {'name': 'Varenicline', 'type': 'DRUG', 'otherNames': ['Champix', 'Chantix'], 'description': 'Days 0-2: 0.5 mg once daily, Days 3-6: 0.5 mg twice daily (morning and evening), Day 7- 84: 1.0 mg twice daily (morning and evening)', 'armGroupLabels': ['NicVAX conjugate vaccine', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6200 MD', 'city': 'Maastricht', 'state': 'Limburg', 'country': 'Netherlands', 'facility': 'Maastricht University Medical Center', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}, {'zip': '1006 BK', 'city': 'Amsterdam', 'state': 'North Holland', 'country': 'Netherlands', 'facility': 'Slotervaart Hospital/ Smoking Cessation Clinic', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}], 'overallOfficials': [{'name': 'Onno van Schayck, Professor Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maastricht University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maastricht University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'ZonMw: The Netherlands Organisation for Health Research and Development', 'class': 'OTHER'}, {'name': 'Nabi Biopharmaceuticals', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}