Ignite Creation Date:
2025-12-25 @ 12:15 AM
Ignite Modification Date:
2026-01-02 @ 11:50 AM
Study NCT ID:
NCT01034358
Status:
COMPLETED
Last Update Posted:
2012-10-23
First Post:
2009-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Immune Response to the Human Papillomavirus Vaccine in Young Women With Inflammatory Bowel Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D002578', 'term': 'Uterine Cervical Dysplasia'}, {'id': 'D003424', 'term': 'Crohn Disease'}, {'id': 'D003093', 'term': 'Colitis, Ulcerative'}], 'ancestors': [{'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D011230', 'term': 'Precancerous Conditions'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D003092', 'term': 'Colitis'}, {'id': 'D003108', 'term': 'Colonic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D053918', 'term': 'Papillomavirus Vaccines'}, {'id': 'D000068857', 'term': 'Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18'}], 'ancestors': [{'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D017778', 'term': 'Vaccines, Combined'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'tung.jeanne@mayo.edu', 'phone': '507-266-0114', 'title': 'Jeanne Tung, MD', 'organization': 'Mayo Clinic'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected over the 12 month period of the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Human Papillomavirus Vaccine', 'description': 'The Gardasil HPV vaccine was administered in 3 doses: baseline, 2 months, and 6 months.', 'otherNumAtRisk': 15, 'otherNumAffected': 13, 'seriousNumAtRisk': 15, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lightheadedness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sore Throat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Twelve Month Antibody Response to the Human Papillomavirus (HPV) Vaccine (Geometric Mean Titers [GMT])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Human Papillomavirus Vaccine', 'description': 'The Gardasil HPV vaccine was administered in 3 doses: baseline, 2 months, and 6 months.'}], 'classes': [{'title': 'HPV 6', 'categories': [{'measurements': [{'value': '120.5', 'groupId': 'OG000', 'lowerLimit': '69.3', 'upperLimit': '209.4'}]}]}, {'title': 'HPV 11', 'categories': [{'measurements': [{'value': '175.0', 'groupId': 'OG000', 'lowerLimit': '86.3', 'upperLimit': '354.0'}]}]}, {'title': 'HPV 16', 'categories': [{'measurements': [{'value': '861.0', 'groupId': 'OG000', 'lowerLimit': '559.8', 'upperLimit': '1321.3'}]}]}, {'title': 'HPV 18', 'categories': [{'measurements': [{'value': '68.9', 'groupId': 'OG000', 'lowerLimit': '34.9', 'upperLimit': '135.5'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'One year', 'description': 'Anti-HPV levels were determined by an assay conducted by Merck \\& Co, Inc. and expressed as milliMerck units per milliliter (mMU/mL).', 'unitOfMeasure': 'mMU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Human Papillomavirus Vaccine', 'description': 'The Gardasil HPV vaccine was administered in 3 doses: baseline, 2 months, and 6 months.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'One patient was found after enrollment to have already received one prior dose of the HPV vaccine.', 'groupId': 'FG000', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Between March 2010 and January 2011, female patients between age 12-25 years of age were recruited through the Inflammatory Bowel Disease Clinics at the Mayo Clinic.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Human Papillomavirus Vaccine', 'description': 'The Gardasil HPV vaccine was administered in 3 doses: baseline, 2 months, and 6 months.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '19.3', 'spread': '3.68', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Disease Activity at First HPV vaccine dose', 'classes': [{'title': 'Quiescent', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}, {'title': 'Active', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Participants were categorized as either having quiescent (inactivity or dormancy) or active disease activity at baseline, prior to first HPV vaccine dose.', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-09-21', 'studyFirstSubmitDate': '2009-12-10', 'resultsFirstSubmitDate': '2012-09-21', 'studyFirstSubmitQcDate': '2009-12-16', 'lastUpdatePostDateStruct': {'date': '2012-10-23', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-09-21', 'studyFirstPostDateStruct': {'date': '2009-12-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-10-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Twelve Month Antibody Response to the Human Papillomavirus (HPV) Vaccine (Geometric Mean Titers [GMT])', 'timeFrame': 'One year', 'description': 'Anti-HPV levels were determined by an assay conducted by Merck \\& Co, Inc. and expressed as milliMerck units per milliliter (mMU/mL).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['inflammatory bowel disease', 'Crohn disease', 'ulcerative colitis', 'Papillomavirus vaccines'], 'conditions': ['Inflammatory Bowel Disease', 'Uterine Cervical Dysplasia']}, 'descriptionModule': {'briefSummary': 'The Gardasil vaccine, a vaccine targeted towards the human papillomavirus (HPV), has been shown to prevent the transmission of several strains of HPV in young women. Women with inflammatory bowel disease (IBD) may not respond as well to this vaccine, either due to having IBD or due to immunosuppressants used to control IBD. This study will test how well women with IBD respond to the Gardasil vaccine.', 'detailedDescription': 'Although guidelines exist for immunization of patients with inflammatory bowel disease, few studies exist demonstrating vaccine efficacy in this population. In patients with inflammatory bowel disease, lower than normal humoral responses have been shown with the tetanus toxoid booster, oral cholera, and influenza vaccinations. It is currently uncertain whether women with inflammatory bowel disease (IBD) have an increased risk of cervical dysplasia and cancer. Gardasil, a vaccine against human papilloma viruses (HPV) 6, 11, 16, and 18, has been approved for the prevention of cervical dysplasias and cancers in women ages 9-26 years. However, its immune response in immunocompromised or immunosuppressed patients is unknown.\n\nYoung women with inflammatory bowel disease who have not received the HPV vaccine will receive the vaccine. The vaccine is given in 3 doses over 6 months. Response to the vaccine will be measured 6 months after completing the vaccine series.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '26 Years', 'minimumAge': '9 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Women 9-26 years of age\n2. Have inflammatory bowel disease (ie. Crohns disease or ulcerative colitis)\n\nExclusion Criteria:\n\n1. Pregnancy\n2. Taking corticosteroids\n3. Allergy to yeast aluminum component of the HPV vaccine\n4. Positive for all HPV types in the Gardasil vaccine-6, 11, 16, 18'}, 'identificationModule': {'nctId': 'NCT01034358', 'briefTitle': 'Immune Response to the Human Papillomavirus Vaccine in Young Women With Inflammatory Bowel Disease', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Comparison of Immune Response to the Human Papillomavirus Vaccine in Young Women With and Without Inflammatory Bowel Disease', 'orgStudyIdInfo': {'id': '09-000485'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Human Papillomavirus Vaccine', 'description': 'The Gardasil HPV vaccine was administered in 3 doses: baseline, 2 months, and 6 months.', 'interventionNames': ['Biological: Human Papillomavirus Vaccine']}], 'interventions': [{'name': 'Human Papillomavirus Vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['Gardasil'], 'description': '0.5mL intramuscular for 3 doses at 0, 2, and 6 months', 'armGroupLabels': ['Human Papillomavirus Vaccine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Jeanne Tung, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Jeanne Tung, MD', 'oldOrganization': 'Mayo Clinic'}}}}