Ignite Creation Date:
2025-12-24 @ 6:43 PM
Ignite Modification Date:
2025-12-30 @ 11:45 PM
Study NCT ID:
NCT04235257
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-03-27
First Post:
2020-01-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intradermal, Fractional Dose of HPV Vaccines:
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D030361', 'term': 'Papillomavirus Infections'}], 'ancestors': [{'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D014412', 'term': 'Tumor Virus Infections'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D053918', 'term': 'Papillomavirus Vaccines'}], 'ancestors': [{'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-24', 'studyFirstSubmitDate': '2020-01-16', 'studyFirstSubmitQcDate': '2020-01-16', 'lastUpdatePostDateStruct': {'date': '2025-03-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HPV antibody detection after fractional HPV vaccination', 'timeFrame': '12 months', 'description': 'HPV antibody response after delivery of a single, intradermal, fractional dose of the HPV-2 or HPV-9 vaccines'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['HPV Infection', 'HPV Vaccine']}, 'descriptionModule': {'briefSummary': 'This randomized phase IV trial compares fractional dose of bivalent HPV vaccine to fractional dose of nonavalent HPV vaccine among men and women aged 27-45 years in Seattle, Washington. Participants will have immune response assessed at baseline, 4 weeks, 6 months, 12 months, and 24 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '27 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 27-45 years at enrollment\n* Not intending to receive the HPV vaccine series for the duration of the study participation\n* Willing and able to provide written informed consent, undergo clinical evaluation, and adhere to follow-up schedule\n\nExclusion Criteria:\n\n* Prior immunization with HPV-vaccine (Cervarix, Gardasil-4, Gardasil-9)\n* Currently pregnant or breastfeeding\n* Immune deficiency or other immune disorder\n* HIV infection or continued high risk for HIV; patients at risk for HIV who do not have a negative HIV test in the last 6 months will be excluded\n* Cancer or chemotherapy (current, within 6 months, or anticipated in the future) except for fully excised non-melanoma skin cancer)\n* Unstable medical condition (e.g., malignant hypertension, poorly controlled diabetes,\n* Known allergy to vaccine components\n* Prior history of HPV-associated cancer'}, 'identificationModule': {'nctId': 'NCT04235257', 'briefTitle': 'Intradermal, Fractional Dose of HPV Vaccines:', 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': 'Immunogenicity of Fractional Dose of the Bivalent and Nonavalent Intradermal HPV Vaccines.', 'orgStudyIdInfo': {'id': 'STUDY00008961'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bivalent HPV vaccine', 'description': 'One-fifth fractional dose (0.1 ml) of bivalent HPV vaccine administered subcutaneously', 'interventionNames': ['Biological: HPV vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'Nonavalent HPV vaccine', 'description': 'One-fifth fractional dose (0.1 ml) of nonavalent HPV vaccine administered subcutaneously', 'interventionNames': ['Biological: HPV vaccine']}], 'interventions': [{'name': 'HPV vaccine', 'type': 'BIOLOGICAL', 'description': 'Gardasil 9 Bivalent HPV VLP Vaccine, one-fifth dose Nonavalent HPV VLP Vaccine, one-fifth dose', 'armGroupLabels': ['Bivalent HPV vaccine', 'Nonavalent HPV vaccine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington Virology Research Clinic', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Anna Wald, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Washington', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor: School of Medicine', 'investigatorFullName': 'Anna Wald', 'investigatorAffiliation': 'University of Washington'}}}}