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This is randomized, placebo controlled study to determine safety and efficacy of VGX-3100 DNA Vaccine delivered by Electroporation to adult women with biopsy-proven HPV 16 or 18 associated Cervical intraepithelial neoplasia grade 2/3 or 3.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VGX 3100 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VGX 3100 | Biological | 1ml of VGX-3100 delivered IM followed by electroporation at Day 0, Week 4 and Week 12. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Histopathological Regression of Cervical Lesions to CIN 1 or Less as a Measure of Efficacy. | The number of participants with histopathologically confirmed CIN2/3 or CIN 3 associated with HPV16 or HPV18 whose cervical lesions regress to CIN 1 or less at the 36 week visit. | 36 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Virologically-proven Clearance of HPV 16 or 18 in Combination with Histopathological Regression of Cervical Lesions to CIN 1 or Less as a Secondary Measure of Efficacy | The number of participants with histopathologically confirmed CIN2/3 or CIN 3 associated with HPV16 or HPV18 whose cervical lesions regress to CIN 1 or less and have virologically-proven clearance of HPV16 or HPV18 at the 36 week visit. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cornelia Trimble, MD | Johns Hopkins University | Principal Investigator |
| Robert L Parker, Jr., MD | Lyndhurst Gynecologic Associates | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix | Arizona | 85015 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33175656 | Derived | Bhuyan PK, Dallas M, Kraynyak K, Herring T, Morrow M, Boyer J, Duff S, Kim J, Weiner DB. Durability of response to VGX-3100 treatment of HPV16/18 positive cervical HSIL. Hum Vaccin Immunother. 2021 May 4;17(5):1288-1293. doi: 10.1080/21645515.2020.1823778. Epub 2020 Nov 11. | |
| 26386540 | Derived | Trimble CL, Morrow MP, Kraynyak KA, Shen X, Dallas M, Yan J, Edwards L, Parker RL, Denny L, Giffear M, Brown AS, Marcozzi-Pierce K, Shah D, Slager AM, Sylvester AJ, Khan A, Broderick KE, Juba RJ, Herring TA, Boyer J, Lee J, Sardesai NY, Weiner DB, Bagarazzi ML. Safety, efficacy, and immunogenicity of VGX-3100, a therapeutic synthetic DNA vaccine targeting human papillomavirus 16 and 18 E6 and E7 proteins for cervical intraepithelial neoplasia 2/3: a randomised, double-blind, placebo-controlled phase 2b trial. Lancet. 2015 Nov 21;386(10008):2078-2088. doi: 10.1016/S0140-6736(15)00239-1. Epub 2015 Sep 17. |
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| Placebo | Biological | 1ml of placebo delivered IM followed by electroporation at Day 0, Week 4 and Week 12. |
|
| CELLECTRA™-5P | Device | CELLECTRA™-5P is used for electroporation following IM delivery of VGX 3100 or placebo on Day 0, Week 4 and Week 12. |
|
| 36 Weeks |
| Tucson |
| Arizona |
| 85721 |
| United States |
| Colton | California | 92324 | United States |
| La Mesa | California | 91942 | United States |
| Los Angeles | California | 90036 | United States |
| Lakewood | Colorado | 80228 | United States |
| Boynton Beach | Florida | 33472 | United States |
| Fort Lauderdale | Florida | 33316 | United States |
| Sarasota | Florida | 34231 | United States |
| Baltimore | Maryland | 21205 | United States |
| Saginaw | Michigan | 48604 | United States |
| Missoula | Montana | 59808 | United States |
| Port Jefferson | New York | 11777 | United States |
| The Bronx | New York | 10467 | United States |
| Raleigh | North Carolina | 27607 | United States |
| Winston-Salem | North Carolina | 27103 | United States |
| Columbus | Ohio | 43231 | United States |
| Oklahoma City | Oklahoma | 73117 | United States |
| Eugene | Oregon | 97401 | United States |
| Philadelphia | Pennsylvania | 19122 | United States |
| Myrtle Beach | South Carolina | 29572 | United States |
| Murray | Utah | 84107 | United States |
| Pleasant Grove | Utah | 84062 | United States |
| Sandy City | Utah | 84070 | United States |
| Richmond | Virginia | 23233 | United States |
| Renton | Washington | 98055 | United States |
| Spokane | Washington | 99207 | United States |
| Victoria | 3052 | Australia |
| Montreal | Quebec | H3A 1A1 | Canada |
| Vancouver | V5Z-1M9 | Canada |
| Tallinn | Estonia |
| Tartu | Estonia |
| Batumi | 6400 | Georgia |
| Tbilisi | Georgia |
| Bangalore | Karnataka | 560017 | India |
| Jaipur | Rajasthan | 302017 | India |
| Kolkata | India |
| New Delhi | India |
| Pune | 411043 | India |
| San Juan | 00936 | Puerto Rico |
| Bloemfontein | 9301 | South Africa |
| Cape Town | 7925 | South Africa |
| Seoul | South Korea |
| ID | Term |
|---|---|
| D002578 | Uterine Cervical Dysplasia |
| D002583 | Uterine Cervical Neoplasms |
| 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 |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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