Ignite Creation Date:
2025-12-25 @ 1:15 AM
Ignite Modification Date:
2026-02-21 @ 11:18 PM
Study NCT ID:
NCT01478893
Status:
COMPLETED
Last Update Posted:
2016-01-07
First Post:
2011-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Pharmacodynamics of SEL-068 Vaccine in Smokers and Non-Smokers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016540', 'term': 'Smoking Cessation'}], 'ancestors': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 82}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-05', 'studyFirstSubmitDate': '2011-11-18', 'studyFirstSubmitQcDate': '2011-11-21', 'lastUpdatePostDateStruct': {'date': '2016-01-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-11-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess the safety and tolerability of multiple subcutaneous injections of SEL-068 as assessed by frequency of vaccine related adverse events, graded by severity', 'timeFrame': '36 weeks'}], 'secondaryOutcomes': [{'measure': 'Immunogenicity of SEL-068 by measuring anti-nicotine antibody titers by Enzyme-Linked Immunosorbent Assay (ELISA).', 'timeFrame': '36 weeks'}]}, 'conditionsModule': {'keywords': ['nicotine vaccine', 'smoking vaccine', 'smoking cessation', 'SEL-068'], 'conditions': ['Smoking Cessation']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and pharmacodynamics of SEL-068. Increasing subcutaneous doses of SEL-068 will be administered to healthy non-smoker and smoker volunteers. The resulting safety profile and anti-nicotine antibody levels will be evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Primary Inclusion Criteria:\n\n* Healthy Smokers\n* Healthy non-smokers\n* Written informed consent\n\nPrimary Exclusion Criteria:\n\n* Prior exposure to nicotine vaccines\n* Female subjects of childbearing potential\n* Current use of immunosuppressive agents\n* History of or current autoimmune disorder of immunosuppressive condition (e.g. HIV infection)\n* Concurrent participation or participation within 8 weeks prior to the initial study drug administration in a drug/device or biologic investigational research study.'}, 'identificationModule': {'nctId': 'NCT01478893', 'briefTitle': 'Safety and Pharmacodynamics of SEL-068 Vaccine in Smokers and Non-Smokers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Selecta Biosciences, Inc.'}, 'officialTitle': 'A Phase 1 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Pharmacodynamics of Increasing Subcutaneous Doses of SEL-068 in Healthy Non-Smoker and Smoker Adults', 'orgStudyIdInfo': {'id': 'SEL-068/101'}, 'secondaryIdInfos': [{'id': '2011-003272-37', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SEL-068', 'interventionNames': ['Biological: SEL-068']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Saline', 'interventionNames': ['Biological: Saline']}], 'interventions': [{'name': 'SEL-068', 'type': 'BIOLOGICAL', 'description': 'Sub-cutaneous injection, multiple dose', 'armGroupLabels': ['SEL-068']}, {'name': 'Saline', 'type': 'BIOLOGICAL', 'description': 'Sub-cutaneous injection, multiple dose', 'armGroupLabels': ['Saline']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Antwerp', 'country': 'Belgium', 'facility': 'SGS LSS Clinical Pharmacology Unit', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}], 'overallOfficials': [{'name': 'Eva Vets, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'SGS LSS Clinical Pharmacology Unit - Antwerpen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Selecta Biosciences, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}