Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2026-01-03 @ 7:54 PM
Study NCT ID:
NCT02568566
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-14
First Post:
2015-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Recombinant Human Papillomavirus Nonavalent Vaccine in Preventing Human Papilloma Virus in Younger Healthy Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000634046', 'term': 'Human Papillomavirus Recombinant Vaccine nonavalent'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'schow@azcc.arizona.edu', 'phone': '520-626-3358', 'title': 'Sherry Chow, PhD', 'organization': 'University of Arizona'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '30 months', 'eventGroups': [{'id': 'EG000', 'title': 'Prevention (Gardasil 9)', 'description': 'Patients receive recombinant human papillomavirus nonavalent vaccine IM at baseline (priming injection) and at 24 and 30 months (booster injections).\n\nLaboratory Biomarker Analysis: Correlative studies\n\nRecombinant Human Papillomavirus Nonavalent Vaccine: Given IM', 'otherNumAtRisk': 201, 'deathsNumAtRisk': 201, 'otherNumAffected': 151, 'seriousNumAtRisk': 201, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Stomach pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Flu like symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 15}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 69}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper respiratory infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 29}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 11}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 14}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 34}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 14}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sore throat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 11}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Wheezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 201, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Human Papilloma Virus (HPV)16/18 Antibody Titer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Prevention (Gardasil 9)', 'description': 'Patients receive recombinant human papillomavirus nonavalent vaccine IM at baseline (priming injection) and at 24 and 30 months (booster injections).\n\nLaboratory Biomarker Analysis: Correlative studies\n\nRecombinant Human Papillomavirus Nonavalent Vaccine: Given IM'}], 'classes': [{'title': 'Difference in HPV16 titers between 6 and 12 months', 'categories': [{'measurements': [{'value': '-0.55', 'spread': '0.54', 'groupId': 'OG000'}]}]}, {'title': 'Difference in HPV16 titers between 12 and 18 months', 'categories': [{'measurements': [{'value': '0.03', 'spread': '0.62', 'groupId': 'OG000'}]}]}, {'title': 'Difference in HPV16 titers between 18 and 24 months', 'categories': [{'measurements': [{'value': '-0.002', 'spread': '0.64', 'groupId': 'OG000'}]}]}, {'title': 'Difference in HPV18 titers between 6 and 12 months', 'categories': [{'measurements': [{'value': '-0.38', 'spread': '0.46', 'groupId': 'OG000'}]}]}, {'title': 'Difference in HPV18 titers between 12 and 18 months', 'categories': [{'measurements': [{'value': '-0.005', 'spread': '0.53', 'groupId': 'OG000'}]}]}, {'title': 'Difference in HPV18 titers between 18 and 24 months', 'categories': [{'measurements': [{'value': '-0.02', 'spread': '0.63', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Between 6 and 24 months after prime dose and prior to the administration of the second dose', 'description': 'Difference in the log-transformed HPV 16/18 antibody levels between 6 and 12 months, between 12 and 18 months, and between 18 and 24 months after prime dose.', 'unitOfMeasure': 'Log10 IU/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis on participants who provided blood samples in all study visits'}, {'type': 'SECONDARY', 'title': 'Change in the Antibody Titer of Other Carcinogenic HPV Types 31/33/45/52/58 and Non-carcinogenic HPV 6/11', 'timeFrame': 'Data are not available. The study team is working on analyzing the antibody titers of other HPV types.', 'description': 'Difference in the log-transformed HPV type-specific antibody levels between 6 and 12 months, between 12 and 18 months, and between 18 and 24 months after prime dose.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Incidence of Adverse Events, Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0', 'timeFrame': 'Up to 2 weeks post-treatment', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Vaccine Reactogenicity', 'timeFrame': 'Up to 30 months', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Prevention (Gardasil 9)', 'description': 'Patients receive recombinant human papillomavirus nonavalent vaccine IM at baseline (priming injection) and at 24 and 30 months (booster injections).\n\nLaboratory Biomarker Analysis: Correlative studies\n\nRecombinant Human Papillomavirus Nonavalent Vaccine: Given IM'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '201'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '187'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Prevention (Gardasil 9)', 'description': 'Patients receive recombinant human papillomavirus nonavalent vaccine IM at baseline (priming injection) and at 24 and 30 months (booster injections).\n\nLaboratory Biomarker Analysis: Correlative studies\n\nRecombinant Human Papillomavirus Nonavalent Vaccine: Given IM'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '10', 'spread': '0.82', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '143', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '58', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '100', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '100', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '131', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '27', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '201', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-04-23', 'size': 526757, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_001.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2022-02-24T09:39', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 201}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-05-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'dispFirstSubmitDate': '2021-01-11', 'completionDateStruct': {'date': '2026-01-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-11', 'studyFirstSubmitDate': '2015-10-05', 'dispFirstSubmitQcDate': '2021-01-11', 'resultsFirstSubmitDate': '2022-01-24', 'studyFirstSubmitQcDate': '2015-10-05', 'dispFirstPostDateStruct': {'date': '2021-01-12', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2025-07-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-03-14', 'studyFirstPostDateStruct': {'date': '2015-10-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-04-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Human Papilloma Virus (HPV)16/18 Antibody Titer', 'timeFrame': 'Between 6 and 24 months after prime dose and prior to the administration of the second dose', 'description': 'Difference in the log-transformed HPV 16/18 antibody levels between 6 and 12 months, between 12 and 18 months, and between 18 and 24 months after prime dose.'}], 'secondaryOutcomes': [{'measure': 'Change in the Antibody Titer of Other Carcinogenic HPV Types 31/33/45/52/58 and Non-carcinogenic HPV 6/11', 'timeFrame': 'Data are not available. The study team is working on analyzing the antibody titers of other HPV types.', 'description': 'Difference in the log-transformed HPV type-specific antibody levels between 6 and 12 months, between 12 and 18 months, and between 18 and 24 months after prime dose.'}, {'measure': 'Incidence of Adverse Events, Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0', 'timeFrame': 'Up to 2 weeks post-treatment'}, {'measure': 'Vaccine Reactogenicity', 'timeFrame': 'Up to 30 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Human Papillomavirus-Related Carcinoma']}, 'referencesModule': {'references': [{'pmid': '30935375', 'type': 'DERIVED', 'citation': 'Zeng Y, Moscicki AB, Sahasrabuddhe VV, Garcia F, Woo H, Hsu CH, Szabo E, Dimond E, Vanzzini S, Mondragon A, Butler V, DeRose H, Chow HS. A prospective, single-arm, open-label, non-randomized, phase IIa trial of a nonavalent prophylactic HPV vaccine to assess immunogenicity of a prime and deferred-booster dosing schedule among 9-11 year-old girls and boys - clinical protocol. BMC Cancer. 2019 Apr 1;19(1):290. doi: 10.1186/s12885-019-5444-4.'}]}, 'descriptionModule': {'briefSummary': 'Human papillomavirus (HPV) is a common sexually-transmitted virus which causes infections that usually last only a few months, but sometimes can last a long time and cause cancers of the cervix, vagina, vulva, anus or oropharynx over many years among adults. This phase IIA trial studies how well does the nonavalent HPV vaccine (which can prevent nine different types of HPV) work when given in an alternative dosing schedule to heathy young research participants.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To determine the persistence and stability of serologic geometric mean titer (GMT) of HPV 16/18 between 6, 12, 18, and 24 months after the prime dose and prior to the administration of the second dose.\n\nSECONDARY OBJECTIVES:\n\nI. To determine the persistence and stability of serologic GMT of HPV types 6/11/31/33/45/52/58 between 6, 12, 18, and 24 months after prime dose and prior to the administration of the second dose.\n\nII. To assess safety and reactogenicity to each vaccine dose.\n\nOUTLINE:\n\nParticipants receive recombinant human papillomavirus nonavalent vaccine intramuscularly (IM) at baseline (priming injection) and at 24 and 30 months (booster injections).\n\nAfter completion of study, participants are followed up for 2 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Years', 'minimumAge': '9 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy, medically well girls and boys\n* Ability to understand and the willingness to sign a written informed consent document by the legal representative(s) of the participant\n* Ability to understand and the willingness to sign a written assent document by the participant\n\nExclusion Criteria:\n\n* Previous vaccination against HPV\n* The use of any investigational agent within 30 days preceding the first dose of the study vaccine or subsequent participation in another clinical trial at any time during the study period, in which the subject will be exposed to an investigational product\n* Chronic administration of immunosuppressive agents or other immune-modifying drugs or chemotherapeutic agents within six months prior to the first vaccine dose; use of inhaled steroids, nasal sprays, and topical creams for small body areas is allowed\n* Receiving active treatment for cancer or an autoimmune condition\n* Confirmed or suspected immunosuppressive or immunodeficient condition\n* Known bleeding disorders that preclude intramuscular injection (e.g., on anticoagulants or thrombocytopenia)\n* Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal dysfunction, which in the opinion of the investigator precludes administration of the study vaccine\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition of GARDASIL 9 (recombinant human papillomavirus nonavalent vaccine), including yeast allergy\n* Are pregnant'}, 'identificationModule': {'nctId': 'NCT02568566', 'briefTitle': 'Recombinant Human Papillomavirus Nonavalent Vaccine in Preventing Human Papilloma Virus in Younger Healthy Participants', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'A Prospective, Single-arm, Open-label, Non-randomized, Phase IIA Trial of a Nonavalent Prophylactic HPV Vaccine to Assess Immunogenicity of a Prime and Deferred-booster Dosing Schedule Among 9-11 Year-old Girls and Boys', 'orgStudyIdInfo': {'id': 'NCI-2015-01645'}, 'secondaryIdInfos': [{'id': 'NCI-2015-01645', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'N01CN00031', 'link': 'https://reporter.nih.gov/quickSearch/N01CN00031', 'type': 'NIH'}, {'id': 'N01-CN-2012-00031'}, {'id': '1512261519', 'type': 'OTHER', 'domain': 'Banner University Medical Center - Tucson'}, {'id': 'UAZ2015-05-01', 'type': 'OTHER', 'domain': 'DCP'}, {'id': 'P30CA023074', 'link': 'https://reporter.nih.gov/quickSearch/P30CA023074', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Prevention (Gardasil 9)', 'description': 'Patients receive recombinant human papillomavirus nonavalent vaccine IM at baseline (priming injection) and at 24 and 30 months (booster injections).', 'interventionNames': ['Other: Laboratory Biomarker Analysis', 'Biological: Recombinant Human Papillomavirus Nonavalent Vaccine']}], 'interventions': [{'name': 'Laboratory Biomarker Analysis', 'type': 'OTHER', 'description': 'Correlative studies', 'armGroupLabels': ['Prevention (Gardasil 9)']}, {'name': 'Recombinant Human Papillomavirus Nonavalent Vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['Gardasil 9', 'Nonavalent HPV VLP Vaccine', 'Recombinant HPV Nonavalent Vaccine', 'Recombinant Human Papillomavirus 9-valent Vaccine'], 'description': 'Given IM', 'armGroupLabels': ['Prevention (Gardasil 9)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85719', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Banner University Medical Center - Tucson', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA / Jonsson Comprehensive Cancer Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Hsiao-Hui (Sherry) Chow', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Arizona Medical Center-University Campus'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}