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| ID | Type | Description | Link |
|---|---|---|---|
| P50CA098252 | U.S. NIH Grant/Contract | View source | |
| 1R21CA128232 | U.S. NIH Grant/Contract | View source | |
| NA_00020850 | Other Identifier | JHM IRB |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Cancer Institute (NCI) | NIH |
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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.
Primary Objectives
Secondary Objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PMED Delivery - groups 1 and 2 | Experimental | 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. |
|
| IM injections - groups 5 and 6 | Experimental | Subjects will receive pNGVL4a-CRT/E7(detox) intramuscularly at weeks 0, 4, 8 prior to therapeutic resection of their lesion at week 15. |
|
| Intralesional delivery - group 3 and 4 | Experimental | Subjects will receive pNGVL4a-CRT/E7(detox) intra-mucosally at weeks 0, 4, 8 prior to therapeutic resection of their lesion at week 15. |
|
| Intralesional delivery + imiquimod - group 7 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DNA vaccination | Biological | vaccination with pNGVL4a-CRT/E7(detox) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Related Serious Adverse Events | Presence of intervention-related serious adverse events as defined by CTCAE | 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Absence of CIN2/3 Lesion by Week 15 | Number of participants with no CIN2/3 lesion at the week 15 visit | 15 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cornelia L Trimble, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| Johns Hopkins Outpatient Center |
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132 subjects signed consents to be screened for eligibility
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| ID | Title | Description |
|---|---|---|
| FG000 | PMED Delivery - Groups 1 and 2 | 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. DNA vaccination: vaccination with pNGVL4a-CRT/E7(detox) Gene gun vaccine: 8 micrograms (group 1) or 16 micrograms (group 2) therapeutic resection of the lesion: at week 15, all residual lesions will be resected |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Gene gun vaccine | Device | 8 micrograms (group 1) or 16 micrograms (group 2) |
|
|
| intramuscular vaccination | Biological | 1mg (group 3) or 3mg (group 4) of pNGVLra-CRT/E7(detox) administered intramuscularly |
|
|
| intra-lesional vaccine administration | Biological | 1mg (group 5) or 3mg (group 6) of pNGVL4a-CRT/E7(detox)administered intra-lesionally |
|
|
| therapeutic resection of the lesion | Procedure | at week 15, all residual lesions will be resected |
|
|
| imiquimod | Drug | imiquimod applied to the cervix by the physician |
|
| Baltimore |
| Maryland |
| 21205 |
| United States |
| Johns Hopkins Bayview Medical Center | Baltimore | Maryland | 21224 | United States |
| FG001 | IM Injections - Groups 5 and 6 | Subjects will receive pNGVL4a-CRT/E7(detox) intramuscularly at weeks 0, 4, 8 prior to therapeutic resection of their lesion at week 15. DNA vaccination: vaccination with pNGVL4a-CRT/E7(detox) intramuscular vaccination: 1mg (group 3) or 3mg (group 4) of pNGVLra-CRT/E7(detox) administered intramuscularly therapeutic resection of the lesion: at week 15, all residual lesions will be resected |
| FG002 | Intralesional Delivery - Group 3 and 4 | Subjects will receive pNGVL4a-CRT/E7(detox) intra-mucosally at weeks 0, 4, 8 prior to therapeutic resection of their lesion at week 15. DNA vaccination: vaccination with pNGVL4a-CRT/E7(detox) intra-lesional vaccine administration: 1mg (group 5) or 3mg (group 6) of pNGVL4a-CRT/E7(detox)administered intra-lesionally therapeutic resection of the lesion: at week 15, all residual lesions will be resected |
| FG003 | Intralesional Delivery + Imiquimod - Group 7 | 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. DNA vaccination: vaccination with pNGVL4a-CRT/E7(detox) intra-lesional vaccine administration: 1mg (group 5) or 3mg (group 6) of pNGVL4a-CRT/E7(detox)administered intra-lesionally therapeutic resection of the lesion: at week 15, all residual lesions will be resected imiquimod: imiquimod applied to the cervix by the physician |
| COMPLETED |
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| NOT COMPLETED |
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Participants enrolled in the study who received at least one study intervention
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| ID | Title | Description |
|---|---|---|
| BG000 | PMED Delivery - Groups 1 and 2 | 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. DNA vaccination: vaccination with pNGVL4a-CRT/E7(detox) Gene gun vaccine: 8 micrograms (group 1) or 16 micrograms (group 2) therapeutic resection of the lesion: at week 15, all residual lesions will be resected |
| BG001 | IM Injections - Groups 5 and 6 | Subjects will receive pNGVL4a-CRT/E7(detox) intramuscularly at weeks 0, 4, 8 prior to therapeutic resection of their lesion at week 15. DNA vaccination: vaccination with pNGVL4a-CRT/E7(detox) intramuscular vaccination: 1mg (group 3) or 3mg (group 4) of pNGVLra-CRT/E7(detox) administered intramuscularly therapeutic resection of the lesion: at week 15, all residual lesions will be resected |
| BG002 | Intralesional Delivery - Group 3 and 4 | Subjects will receive pNGVL4a-CRT/E7(detox) intra-mucosally at weeks 0, 4, 8 prior to therapeutic resection of their lesion at week 15. DNA vaccination: vaccination with pNGVL4a-CRT/E7(detox) intra-lesional vaccine administration: 1mg (group 5) or 3mg (group 6) of pNGVL4a-CRT/E7(detox)administered intra-lesionally therapeutic resection of the lesion: at week 15, all residual lesions will be resected |
| BG003 | Intralesional Delivery + Imiquimod - Group 7 | 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. DNA vaccination: vaccination with pNGVL4a-CRT/E7(detox) intra-lesional vaccine administration: 1mg (group 5) or 3mg (group 6) of pNGVL4a-CRT/E7(detox)administered intra-lesionally therapeutic resection of the lesion: at week 15, all residual lesions will be resected imiquimod: imiquimod applied to the cervix by the physician |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Related Serious Adverse Events | Presence of intervention-related serious adverse events as defined by CTCAE | Related Serious Adverse Events | Posted | Count of Participants | Participants | 9 months |
|
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Absence of CIN2/3 Lesion by Week 15 | Number of participants with no CIN2/3 lesion at the week 15 visit | Number of participants who had no CIN2/3 at the week 15 resection | Posted | Count of Participants | Participants | 15 weeks |
|
41 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PMED Delivery - Groups 1 and 2 | 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. DNA vaccination: vaccination with pNGVL4a-CRT/E7(detox) Gene gun vaccine: 8 micrograms (group 1) or 16 micrograms (group 2) therapeutic resection of the lesion: at week 15, all residual lesions will be resected | 0 | 10 | 10 | 10 | ||
| EG001 | IM Injections - Groups 5 and 6 | Subjects will receive pNGVL4a-CRT/E7(detox) intramuscularly at weeks 0, 4, 8 prior to therapeutic resection of their lesion at week 15. DNA vaccination: vaccination with pNGVL4a-CRT/E7(detox) intramuscular vaccination: 1mg (group 3) or 3mg (group 4) of pNGVLra-CRT/E7(detox) administered intramuscularly therapeutic resection of the lesion: at week 15, all residual lesions will be resected | 0 | 11 | 11 | 11 | ||
| EG002 | Intralesional Delivery - Group 3 and 4 | Subjects will receive pNGVL4a-CRT/E7(detox) intra-mucosally at weeks 0, 4, 8 prior to therapeutic resection of their lesion at week 15. DNA vaccination: vaccination with pNGVL4a-CRT/E7(detox) intra-lesional vaccine administration: 1mg (group 5) or 3mg (group 6) of pNGVL4a-CRT/E7(detox)administered intra-lesionally therapeutic resection of the lesion: at week 15, all residual lesions will be resected | 0 | 11 | 10 | 11 | ||
| EG003 | Intralesional Delivery + Imiquimod - Group 7 | 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. DNA vaccination: vaccination with pNGVL4a-CRT/E7(detox) intra-lesional vaccine administration: 1mg (group 5) or 3mg (group 6) of pNGVL4a-CRT/E7(detox)administered intra-lesionally therapeutic resection of the lesion: at week 15, all residual lesions will be resected imiquimod: imiquimod applied to the cervix by the physician | 0 | 7 | 7 | 7 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site reactions | General disorders | Systematic Assessment | Local injection site reactions |
| |
| General pain, fever, malaise/fatigue | General disorders | Systematic Assessment | Abdominal discomfort, cramping, fatigue, flu like symptoms, headaches, muscle/joint aches, nausea, pain, pruritus |
| |
| Depression | Psychiatric disorders | Systematic Assessment |
| ||
| Limb numbness | Nervous system disorders | Systematic Assessment |
| ||
| Rash | Infections and infestations | Systematic Assessment |
| ||
| Vaginal bleeding/spotting | Reproductive system and breast disorders | Systematic Assessment | vaginal bleeding or spotting |
| |
| Laryngeal inflammation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cornelia L. Trimble, MD | Johns Hopkins University | 410-502-0512 | ctrimbl@jhmi.edu |
| ID | Term |
|---|---|
| D002578 | Uterine Cervical Dysplasia |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| D014612 | Vaccines |
| D019444 | Vaccines, DNA |
| D019092 | Conization |
| D000077271 | Imiquimod |
| ID | Term |
|---|---|
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D000087504 | Nucleic Acid-Based Vaccines |
| D014614 | Vaccines, Synthetic |
| D011994 | Recombinant Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000941 | Antigens |
| D001685 | Biological Factors |
| D001706 | Biopsy |
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013048 | Specimen Handling |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG003 | Intralesional Delivery + Imiquimod - Group 7 | 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. DNA vaccination: vaccination with pNGVL4a-CRT/E7(detox) intra-lesional vaccine administration: 1mg (group 5) or 3mg (group 6) of pNGVL4a-CRT/E7(detox)administered intra-lesionally therapeutic resection of the lesion: at week 15, all residual lesions will be resected imiquimod: imiquimod applied to the cervix by the physician |
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