Ignite Creation Date:
2025-12-24 @ 2:31 PM
Ignite Modification Date:
2026-04-16 @ 3:10 PM
Study NCT ID:
NCT00988559
Status:
COMPLETED
Last Update Posted:
2018-07-09
First Post:
2009-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Therapeutic Vaccination for Patients With HPV16+ Cervical Intraepithelial Neoplasia (CIN2/3)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002578', 'term': 'Uterine Cervical Dysplasia'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D019444', 'term': 'Vaccines, DNA'}, {'id': 'D019092', 'term': 'Conization'}, {'id': 'D000077271', 'term': 'Imiquimod'}], 'ancestors': [{'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D000087504', 'term': 'Nucleic Acid-Based Vaccines'}, {'id': 'D014614', 'term': 'Vaccines, Synthetic'}, {'id': 'D011994', 'term': 'Recombinant Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000941', 'term': 'Antigens'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D001706', 'term': 'Biopsy'}, {'id': 'D003581', 'term': 'Cytodiagnosis'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D000634', 'term': 'Aminoquinolines'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ctrimbl@jhmi.edu', 'phone': '410-502-0512', 'title': 'Cornelia L. Trimble, MD', 'organization': 'Johns Hopkins University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '41 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'PMED Delivery - Groups 1 and 2', 'description': 'Subjects will receive pNGVL4a-CRT/E7(detox) via gene gun at weeks 0, 4, 8 prior to therapeutic resection of their lesion at week 15.\n\nDNA vaccination: vaccination with pNGVL4a-CRT/E7(detox)\n\nGene gun vaccine: 8 micrograms (group 1) or 16 micrograms (group 2)\n\ntherapeutic resection of the lesion: at week 15, all residual lesions will be resected', 'otherNumAtRisk': 10, 'otherNumAffected': 10, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'IM Injections - Groups 5 and 6', 'description': 'Subjects will receive pNGVL4a-CRT/E7(detox) intramuscularly at weeks 0, 4, 8 prior to therapeutic resection of their lesion at week 15.\n\nDNA vaccination: vaccination with pNGVL4a-CRT/E7(detox)\n\nintramuscular vaccination: 1mg (group 3) or 3mg (group 4) of pNGVLra-CRT/E7(detox) administered intramuscularly\n\ntherapeutic resection of the lesion: at week 15, all residual lesions will be resected', 'otherNumAtRisk': 11, 'otherNumAffected': 11, 'seriousNumAtRisk': 11, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Intralesional Delivery - Group 3 and 4', 'description': 'Subjects will receive pNGVL4a-CRT/E7(detox) intra-mucosally at weeks 0, 4, 8 prior to therapeutic resection of their lesion at week 15.\n\nDNA vaccination: vaccination with pNGVL4a-CRT/E7(detox)\n\nintra-lesional vaccine administration: 1mg (group 5) or 3mg (group 6) of pNGVL4a-CRT/E7(detox)administered intra-lesionally\n\ntherapeutic resection of the lesion: at week 15, all residual lesions will be resected', 'otherNumAtRisk': 11, 'otherNumAffected': 10, 'seriousNumAtRisk': 11, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Intralesional Delivery + Imiquimod - Group 7', 'description': 'Subjects will receive pNGVL4a-CRT/E7(detox) intra-mucosally and imiquimod applied to the cervix at weeks 0, 4, 8 prior to therapeutic resection of their lesion at week 15.\n\nDNA vaccination: vaccination with pNGVL4a-CRT/E7(detox)\n\nintra-lesional vaccine administration: 1mg (group 5) or 3mg (group 6) of pNGVL4a-CRT/E7(detox)administered intra-lesionally\n\ntherapeutic resection of the lesion: at week 15, all residual lesions will be resected\n\nimiquimod: imiquimod applied to the cervix by the physician', 'otherNumAtRisk': 7, 'otherNumAffected': 7, 'seriousNumAtRisk': 7, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Injection site reactions', 'notes': 'Local injection site reactions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 43, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 10, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'General pain, fever, malaise/fatigue', 'notes': 'Abdominal discomfort, cramping, fatigue, flu like symptoms, headaches, muscle/joint aches, nausea, pain, pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 44, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 38, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 41, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 37, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Limb numbness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vaginal bleeding/spotting', 'notes': 'vaginal bleeding or spotting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 6, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Laryngeal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Related Serious Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PMED Delivery - Groups 1 and 2', 'description': 'Subjects will receive pNGVL4a-CRT/E7(detox) via gene gun at weeks 0, 4, 8 prior to therapeutic resection of their lesion at week 15.\n\nDNA vaccination: vaccination with pNGVL4a-CRT/E7(detox)\n\nGene gun vaccine: 8 micrograms (group 1) or 16 micrograms (group 2)\n\ntherapeutic resection of the lesion: at week 15, all residual lesions will be resected'}, {'id': 'OG001', 'title': 'IM Injections - Groups 5 and 6', 'description': 'Subjects will receive pNGVL4a-CRT/E7(detox) intramuscularly at weeks 0, 4, 8 prior to therapeutic resection of their lesion at week 15.\n\nDNA vaccination: vaccination with pNGVL4a-CRT/E7(detox)\n\nintramuscular vaccination: 1mg (group 3) or 3mg (group 4) of pNGVLra-CRT/E7(detox) administered intramuscularly\n\ntherapeutic resection of the lesion: at week 15, all residual lesions will be resected'}, {'id': 'OG002', 'title': 'Intralesional Delivery - Group 3 and 4', 'description': 'Subjects will receive pNGVL4a-CRT/E7(detox) intra-mucosally at weeks 0, 4, 8 prior to therapeutic resection of their lesion at week 15.\n\nDNA vaccination: vaccination with pNGVL4a-CRT/E7(detox)\n\nintra-lesional vaccine administration: 1mg (group 5) or 3mg (group 6) of pNGVL4a-CRT/E7(detox)administered intra-lesionally\n\ntherapeutic resection of the lesion: at week 15, all residual lesions will be resected'}, {'id': 'OG003', 'title': 'Intralesional Delivery + Imiquimod - Group 7', 'description': 'Subjects will receive pNGVL4a-CRT/E7(detox) intra-mucosally and imiquimod applied to the cervix at weeks 0, 4, 8 prior to therapeutic resection of their lesion at week 15.\n\nDNA vaccination: vaccination with pNGVL4a-CRT/E7(detox)\n\nintra-lesional vaccine administration: 1mg (group 5) or 3mg (group 6) of pNGVL4a-CRT/E7(detox)administered intra-lesionally\n\ntherapeutic resection of the lesion: at week 15, all residual lesions will be resected\n\nimiquimod: imiquimod applied to the cervix by the physician'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '9 months', 'description': 'Presence of intervention-related serious adverse events as defined by CTCAE', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Related Serious Adverse Events'}, {'type': 'SECONDARY', 'title': 'Absence of CIN2/3 Lesion by Week 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PMED Delivery - Groups 1 and 2', 'description': 'Subjects will receive pNGVL4a-CRT/E7(detox) via gene gun at weeks 0, 4, 8 prior to therapeutic resection of their lesion at week 15.\n\nDNA vaccination: vaccination with pNGVL4a-CRT/E7(detox)\n\nGene gun vaccine: 8 micrograms (group 1) or 16 micrograms (group 2)\n\ntherapeutic resection of the lesion: at week 15, all residual lesions will be resected'}, {'id': 'OG001', 'title': 'IM Injections - Groups 5 and 6', 'description': 'Subjects will receive pNGVL4a-CRT/E7(detox) intramuscularly at weeks 0, 4, 8 prior to therapeutic resection of their lesion at week 15.\n\nDNA vaccination: vaccination with pNGVL4a-CRT/E7(detox)\n\nintramuscular vaccination: 1mg (group 3) or 3mg (group 4) of pNGVLra-CRT/E7(detox) administered intramuscularly\n\ntherapeutic resection of the lesion: at week 15, all residual lesions will be resected'}, {'id': 'OG002', 'title': 'Intralesional Delivery - Group 3 and 4', 'description': 'Subjects will receive pNGVL4a-CRT/E7(detox) intra-mucosally at weeks 0, 4, 8 prior to therapeutic resection of their lesion at week 15.\n\nDNA vaccination: vaccination with pNGVL4a-CRT/E7(detox)\n\nintra-lesional vaccine administration: 1mg (group 5) or 3mg (group 6) of pNGVL4a-CRT/E7(detox)administered intra-lesionally\n\ntherapeutic resection of the lesion: at week 15, all residual lesions will be resected'}, {'id': 'OG003', 'title': 'Intralesional Delivery + Imiquimod - Group 7', 'description': 'Subjects will receive pNGVL4a-CRT/E7(detox) intra-mucosally and imiquimod applied to the cervix at weeks 0, 4, 8 prior to therapeutic resection of their lesion at week 15.\n\nDNA vaccination: vaccination with pNGVL4a-CRT/E7(detox)\n\nintra-lesional vaccine administration: 1mg (group 5) or 3mg (group 6) of pNGVL4a-CRT/E7(detox)administered intra-lesionally\n\ntherapeutic resection of the lesion: at week 15, all residual lesions will be resected\n\nimiquimod: imiquimod applied to the cervix by the physician'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '15 weeks', 'description': 'Number of participants with no CIN2/3 lesion at the week 15 visit', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants who had no CIN2/3 at the week 15 resection'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PMED Delivery - Groups 1 and 2', 'description': 'Subjects will receive pNGVL4a-CRT/E7(detox) via gene gun at weeks 0, 4, 8 prior to therapeutic resection of their lesion at week 15.\n\nDNA vaccination: vaccination with pNGVL4a-CRT/E7(detox)\n\nGene gun vaccine: 8 micrograms (group 1) or 16 micrograms (group 2)\n\ntherapeutic resection of the lesion: at week 15, all residual lesions will be resected'}, {'id': 'FG001', 'title': 'IM Injections - Groups 5 and 6', 'description': 'Subjects will receive pNGVL4a-CRT/E7(detox) intramuscularly at weeks 0, 4, 8 prior to therapeutic resection of their lesion at week 15.\n\nDNA vaccination: vaccination with pNGVL4a-CRT/E7(detox)\n\nintramuscular vaccination: 1mg (group 3) or 3mg (group 4) of pNGVLra-CRT/E7(detox) administered intramuscularly\n\ntherapeutic resection of the lesion: at week 15, all residual lesions will be resected'}, {'id': 'FG002', 'title': 'Intralesional Delivery - Group 3 and 4', 'description': 'Subjects will receive pNGVL4a-CRT/E7(detox) intra-mucosally at weeks 0, 4, 8 prior to therapeutic resection of their lesion at week 15.\n\nDNA vaccination: vaccination with pNGVL4a-CRT/E7(detox)\n\nintra-lesional vaccine administration: 1mg (group 5) or 3mg (group 6) of pNGVL4a-CRT/E7(detox)administered intra-lesionally\n\ntherapeutic resection of the lesion: at week 15, all residual lesions will be resected'}, {'id': 'FG003', 'title': 'Intralesional Delivery + Imiquimod - Group 7', 'description': 'Subjects will receive pNGVL4a-CRT/E7(detox) intra-mucosally and imiquimod applied to the cervix at weeks 0, 4, 8 prior to therapeutic resection of their lesion at week 15.\n\nDNA vaccination: vaccination with pNGVL4a-CRT/E7(detox)\n\nintra-lesional vaccine administration: 1mg (group 5) or 3mg (group 6) of pNGVL4a-CRT/E7(detox)administered intra-lesionally\n\ntherapeutic resection of the lesion: at week 15, all residual lesions will be resected\n\nimiquimod: imiquimod applied to the cervix by the physician'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': '132 subjects signed consents to be screened for eligibility\n\n* 93 subjects signed consents, but did not meet the eligibility criteria to start the study (screen failures)\n* 39 subjects were assigned to a treatment group in the study'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '39', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'PMED Delivery - Groups 1 and 2', 'description': 'Subjects will receive pNGVL4a-CRT/E7(detox) via gene gun at weeks 0, 4, 8 prior to therapeutic resection of their lesion at week 15.\n\nDNA vaccination: vaccination with pNGVL4a-CRT/E7(detox)\n\nGene gun vaccine: 8 micrograms (group 1) or 16 micrograms (group 2)\n\ntherapeutic resection of the lesion: at week 15, all residual lesions will be resected'}, {'id': 'BG001', 'title': 'IM Injections - Groups 5 and 6', 'description': 'Subjects will receive pNGVL4a-CRT/E7(detox) intramuscularly at weeks 0, 4, 8 prior to therapeutic resection of their lesion at week 15.\n\nDNA vaccination: vaccination with pNGVL4a-CRT/E7(detox)\n\nintramuscular vaccination: 1mg (group 3) or 3mg (group 4) of pNGVLra-CRT/E7(detox) administered intramuscularly\n\ntherapeutic resection of the lesion: at week 15, all residual lesions will be resected'}, {'id': 'BG002', 'title': 'Intralesional Delivery - Group 3 and 4', 'description': 'Subjects will receive pNGVL4a-CRT/E7(detox) intra-mucosally at weeks 0, 4, 8 prior to therapeutic resection of their lesion at week 15.\n\nDNA vaccination: vaccination with pNGVL4a-CRT/E7(detox)\n\nintra-lesional vaccine administration: 1mg (group 5) or 3mg (group 6) of pNGVL4a-CRT/E7(detox)administered intra-lesionally\n\ntherapeutic resection of the lesion: at week 15, all residual lesions will be resected'}, {'id': 'BG003', 'title': 'Intralesional Delivery + Imiquimod - Group 7', 'description': 'Subjects will receive pNGVL4a-CRT/E7(detox) intra-mucosally and imiquimod applied to the cervix at weeks 0, 4, 8 prior to therapeutic resection of their lesion at week 15.\n\nDNA vaccination: vaccination with pNGVL4a-CRT/E7(detox)\n\nintra-lesional vaccine administration: 1mg (group 5) or 3mg (group 6) of pNGVL4a-CRT/E7(detox)administered intra-lesionally\n\ntherapeutic resection of the lesion: at week 15, all residual lesions will be resected\n\nimiquimod: imiquimod applied to the cervix by the physician'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '25.5', 'groupId': 'BG000', 'lowerLimit': '20', 'upperLimit': '44'}, {'value': '26', 'groupId': 'BG001', 'lowerLimit': '21', 'upperLimit': '35'}, {'value': '26', 'groupId': 'BG002', 'lowerLimit': '23', 'upperLimit': '35'}, {'value': '26.14', 'groupId': 'BG003', 'lowerLimit': '24', 'upperLimit': '29'}, {'value': '25.91', 'groupId': 'BG004', 'lowerLimit': '20', 'upperLimit': '44'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '39', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '26', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Participants enrolled in the study who received at least one study intervention'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 132}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-06', 'studyFirstSubmitDate': '2009-10-01', 'resultsFirstSubmitDate': '2016-10-27', 'studyFirstSubmitQcDate': '2009-10-01', 'lastUpdatePostDateStruct': {'date': '2018-07-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-07-06', 'studyFirstPostDateStruct': {'date': '2009-10-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-07-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Related Serious Adverse Events', 'timeFrame': '9 months', 'description': 'Presence of intervention-related serious adverse events as defined by CTCAE'}], 'secondaryOutcomes': [{'measure': 'Absence of CIN2/3 Lesion by Week 15', 'timeFrame': '15 weeks', 'description': 'Number of participants with no CIN2/3 lesion at the week 15 visit'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['high grade cervical dysplasia', 'treatment vaccine', 'therapeutic', 'HPV', 'DNA vaccine', 'gene therapy', 'gene gun', 'pre-cancerous'], 'conditions': ['HPV16 Positive', 'Cervical Intraepithelial Neoplasia (CIN 2/3)']}, 'descriptionModule': {'briefSummary': 'This study will test the efficacy and safety of different routes of administration of a DNA vaccine in patients with HPV16+ CIN2/3. Subjects will be enrolled in one of six treatment groups. Subjects enrolled in the first two groups will receive vaccination intradermally with a needle-free delivery device. Subjects enrolled in groups 3 and 4 will receive vaccination intramuscularly. Subjects enrolled in groups 5 and 6 will receive vaccine intralesionally.', 'detailedDescription': 'Primary Objectives\n\n* To evaluate the feasibility and toxicity of vaccination in women with CIN2/3 caused by HPV16\n* To evaluate the effect of vaccination on histology\n* To compare immunogenicity of three different routes of administration: intradermal (ID), intramuscular (IM), intralesional (IL).\n\nSecondary Objectives:\n\n* To evaluate changes in HPV viral load\n* To evaluate the cellular immune response to vaccination\n* To evaluate the humoral immune response to vaccination\n* To evaluate local tissue immune response\n* To correlate measures of immune response with clinical response\n* To correlate measures of immune response with those observed in the preclinical model'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* patients with high grade cervical intraepithelial lesions (CIN2/3)\n* patients whose lesions are HPV16+\n* patients who are age 18 or older\n* patients who are able to give informed consent\n* patients who are immunocompetent\n* patients who are not pregnant, committed to using adequate contraception if of childbearing age\n* patients who have a minimum hemoglobin level of 9\n\nExclusion Criteria:\n\n* Patients with cytologic evidence of glandular dysplasia\n* Patients with cytologic evidence of adenocarcinoma in situ\n* Patients who are pregnant\n* Patients with an active autoimmune disease\n* Patients who are taking immunosuppressive medication\n* Patients with concurrent malignancy except for nonmelanoma skin lesions\n* Patients who have an allergy to gold.\n* Patients with any evidence of damaged skin, or moles, scars, tattoos or marks at the proposed site(s) of administration that might interfere with the interpretation of local skin reactions.\n* History or evidence of a physician-diagnosed chronic or recurrent inflammatory skin disease (e.g. psoriasis, eczema, atopic dermatitis, hypersensitivity) at the proposed site of administration in the past 5 years.\n* Patients who have an active autoimmune disease or history of autoimmune disease requiring medical treatment with systemic immunosuppressants, including: inflammatory bowel disease, systemic vasculitis, scleroderma, psoriasis, multiple sclerosis, hemolytic anemic, or immune thrombocytopenia, rheumatoid arthritis, SLE, and Sjogren's syndrome, sarcoidosis. Asthma or COPD that does not require systemic corticosteroids or routine use of inhaled steroids is acceptable\n* Patients who have received prior chrysotherapy (administration of gold salts to treat rheumatoid arthritis).\n* Patients with a history of arterial or venous thrombosis\n* Patients with non-healed wounds.\n* Patients with a history of keloid formation ( ID delivery group only)\n* Patients with a history of hepatitis B with persistent infection."}, 'identificationModule': {'nctId': 'NCT00988559', 'briefTitle': 'Therapeutic Vaccination for Patients With HPV16+ Cervical Intraepithelial Neoplasia (CIN2/3)', 'organization': {'class': 'OTHER', 'fullName': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins'}, 'officialTitle': 'A Pilot Study of pnGVL4a-CRT/E7 (Detox) for the Treatment of Patients With HPV16+ Cervical Intraepithelial Neoplasia 2/3 (CIN2/3)', 'orgStudyIdInfo': {'id': 'J0866'}, 'secondaryIdInfos': [{'id': 'P50CA098252', 'link': 'https://reporter.nih.gov/quickSearch/P50CA098252', 'type': 'NIH'}, {'id': '1R21CA128232', 'link': 'https://reporter.nih.gov/quickSearch/1R21CA128232', 'type': 'NIH'}, {'id': 'NA_00020850', 'type': 'OTHER', 'domain': 'JHM IRB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PMED Delivery - groups 1 and 2', 'description': 'Subjects will receive pNGVL4a-CRT/E7(detox) via gene gun at weeks 0, 4, 8 prior to therapeutic resection of their lesion at week 15.', 'interventionNames': ['Biological: DNA vaccination', 'Device: Gene gun vaccine', 'Procedure: therapeutic resection of the lesion']}, {'type': 'EXPERIMENTAL', 'label': 'IM injections - groups 5 and 6', 'description': 'Subjects will receive pNGVL4a-CRT/E7(detox) intramuscularly at weeks 0, 4, 8 prior to therapeutic resection of their lesion at week 15.', 'interventionNames': ['Biological: DNA vaccination', 'Biological: intramuscular vaccination', 'Procedure: therapeutic resection of the lesion']}, {'type': 'EXPERIMENTAL', 'label': 'Intralesional delivery - group 3 and 4', 'description': 'Subjects will receive pNGVL4a-CRT/E7(detox) intra-mucosally at weeks 0, 4, 8 prior to therapeutic resection of their lesion at week 15.', 'interventionNames': ['Biological: DNA vaccination', 'Biological: intra-lesional vaccine administration', 'Procedure: therapeutic resection of the lesion']}, {'type': 'EXPERIMENTAL', 'label': 'Intralesional delivery + imiquimod - group 7', 'description': 'Subjects will receive pNGVL4a-CRT/E7(detox) intra-mucosally and imiquimod applied to the cervix at weeks 0, 4, 8 prior to therapeutic resection of their lesion at week 15.', 'interventionNames': ['Biological: DNA vaccination', 'Biological: intra-lesional vaccine administration', 'Procedure: therapeutic resection of the lesion', 'Drug: imiquimod']}], 'interventions': [{'name': 'DNA vaccination', 'type': 'BIOLOGICAL', 'otherNames': ['Therapeutic vaccine'], 'description': 'vaccination with pNGVL4a-CRT/E7(detox)', 'armGroupLabels': ['IM injections - groups 5 and 6', 'Intralesional delivery + imiquimod - group 7', 'Intralesional delivery - group 3 and 4', 'PMED Delivery - groups 1 and 2']}, {'name': 'Gene gun vaccine', 'type': 'DEVICE', 'otherNames': ['PMED administration', 'ND10 device'], 'description': '8 micrograms (group 1) or 16 micrograms (group 2)', 'armGroupLabels': ['PMED Delivery - groups 1 and 2']}, {'name': 'intramuscular vaccination', 'type': 'BIOLOGICAL', 'otherNames': ['DNA vaccine'], 'description': '1mg (group 3) or 3mg (group 4) of pNGVLra-CRT/E7(detox) administered intramuscularly', 'armGroupLabels': ['IM injections - groups 5 and 6']}, {'name': 'intra-lesional vaccine administration', 'type': 'BIOLOGICAL', 'otherNames': ['Intra-lesional DNA vaccination'], 'description': '1mg (group 5) or 3mg (group 6) of pNGVL4a-CRT/E7(detox)administered intra-lesionally', 'armGroupLabels': ['Intralesional delivery + imiquimod - group 7', 'Intralesional delivery - group 3 and 4']}, {'name': 'therapeutic resection of the lesion', 'type': 'PROCEDURE', 'otherNames': ['LEEP or cold knife conization'], 'description': 'at week 15, all residual lesions will be resected', 'armGroupLabels': ['IM injections - groups 5 and 6', 'Intralesional delivery + imiquimod - group 7', 'Intralesional delivery - group 3 and 4', 'PMED Delivery - groups 1 and 2']}, {'name': 'imiquimod', 'type': 'DRUG', 'description': 'imiquimod applied to the cervix by the physician', 'armGroupLabels': ['Intralesional delivery + imiquimod - group 7']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '21205', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Outpatient Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '21224', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Bayview Medical Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Cornelia L Trimble, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}, {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}