Ignite Creation Date:
2025-12-24 @ 10:19 PM
Ignite Modification Date:
2025-12-25 @ 7:52 PM
Study NCT ID:
NCT00175435
Status:
COMPLETED
Last Update Posted:
2010-11-02
First Post:
2005-09-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Optimizing Hepatitis B Vaccine Response Through the Use of a Topical Immune Modulator
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006509', 'term': 'Hepatitis B'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018347', 'term': 'Hepadnaviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-10', 'completionDateStruct': {'date': '2007-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-10-29', 'studyFirstSubmitDate': '2005-09-11', 'studyFirstSubmitQcDate': '2005-09-11', 'lastUpdatePostDateStruct': {'date': '2010-11-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'A single application of an immune modulating gel will enhance the protective response against hepatitis B disease when vaccination is given at the same time as gel as evidenced by increased HB antibody and T-cell response.', 'timeFrame': 'at 30 days after vaccination'}], 'secondaryOutcomes': [{'measure': 'Minimal adverse effects to gel application as noted by laboratory assessment of liver enzyme and complete blood count (CBC) and physical assessment of the site/surrounding area and solicited local and general post vaccine events.', 'timeFrame': 'at 7 and 30 days post vaccine'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Topical Immune Modulator', 'resiquimod gel', 'Hepatitis B booster response', 'Vaccine Evaluation', 'Prevention of Hepatitis B disease'], 'conditions': ['Hepatitis B']}, 'descriptionModule': {'briefSummary': "This study will look at what happens to the level of protection against hepatitis B (HB) disease if a 'helper' gel is applied to the skin over the injection site of a small dose of hepatitis B vaccine."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Previously vaccinated with conventional hepatitis B vaccine series 10 or more years ago\n* Generally healthy\n* Is and has been free of HB disease and/or is negative to core antibody\n* Known to have sero-converted to positive after vaccine series (without extra doses)\n* Speaks and understands English adequately\n* Available for all 4 visits within the designated timelines (30 days)\n* No allergies to HB vaccine or components\n* No blood or blood components within previous 6 months\n* Not pregnant or breastfeeding'}, 'identificationModule': {'nctId': 'NCT00175435', 'briefTitle': 'Optimizing Hepatitis B Vaccine Response Through the Use of a Topical Immune Modulator', 'organization': {'class': 'OTHER', 'fullName': 'University of British Columbia'}, 'officialTitle': 'Optimizing Hepatitis B Vaccine Response Through the Use of a Topical Immune Modulator', 'orgStudyIdInfo': {'id': 'C05-0027'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': '2 doses of HPV vaccine 0.5 mL. given IM with Topical Immune Modulator in 9-13 year-olds.', 'interventionNames': ['Biological: Resiquimod gel']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': '3 doses of HPV vaccine 0.5 mL given IM with Topical Immune Modulator in 9-13 year-olds.', 'interventionNames': ['Biological: Resiquimod gel']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3', 'description': '3 doses HPV vaccine 0.5 mL given IM with Topical Immune Modulator in 16-26 year-olds.', 'interventionNames': ['Biological: Resiquimod gel']}], 'interventions': [{'name': 'Resiquimod gel', 'type': 'BIOLOGICAL', 'otherNames': ['HPV vaccine - Gardasil'], 'description': '3 doses HPV vaccine 0.5 mL given IM with Topical Immune Modulator', 'armGroupLabels': ['1']}, {'name': 'Resiquimod gel', 'type': 'BIOLOGICAL', 'otherNames': ['HPV vaccine = Gardasil'], 'description': '3 doses HPV vaccine 0.5 mL given IM with Topical Immune Modulator.', 'armGroupLabels': ['2']}, {'name': 'Resiquimod gel', 'type': 'BIOLOGICAL', 'otherNames': ['HPV vaccine = Gardasil'], 'description': '3 doses HPV vaccine 0.5 mL given IM with Topical Immune Modulator.', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Vancouver General Hospital Vaccine Education Centre', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}], 'overallOfficials': [{'name': 'Jan Dutz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of British Columbia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of British Columbia', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dr. Jan Dutz', 'oldOrganization': 'University of British Columbia'}}}}