Evaluation of VGX-3100 and Electroporation Alone or in Combination With Imiquimod for the Treatment of HPV-16 and/or HPV-18 Related Vulvar HSIL (Also Referred as: VIN 2 or VIN 3)



Status:Recruiting
Conditions:Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:4/4/2019
Start Date:June 26, 2017
End Date:September 2021
Contact:Inovio Call Center
Email:clinical.trials@inovio.com
Phone:(267) 440-4237

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A Phase 2, Randomized, Open Label, Efficacy Study of VGX-3100 Delivered Intramuscularly Followed by Electroporation With CELLECTRA™ 2000 Alone or in Combination With Imiquimod, for the Treatment of HPV-16 and/or HPV-18 Related High Grade Squamous Intraepithelial Lesion (HSIL) of the Vulva

The purpose of this study is to test the safety and efficacy of an investigational
immunotherapy VGX-3100, in combination with a study device, to treat women with vulvar HSIL
(VIN 2 or VIN 3) associated with HPV types 16 and/or 18. VGX-3100 is being assessed as an
alternative to surgery with the potential to clear the underlying HPV infection. For more
information visit our study website at: www.VINresearchstudy.com


Inclusion Criteria:

- Women aged 18 and above;

- Have high grade squamous intraepithelial lesion (HSIL) of the vulva (VIN2 or VIN3)
caused by infection with HPV types 16 and/or 18 confirmed at screening visit;

Exclusion Criteria:

- Biopsy-proven differentiated VIN;

- Any previous treatment for vulvar HSIL within 4 weeks prior to screening;

- Allergy to imiquimod 5% cream or to an inactive ingredient in imiquimod 5% cream;

- Pregnant, breastfeeding or considering becoming pregnant within 6 months following the
last dose of investigational product;

- Immunosuppression as a result of underlying illness or treatment;

- Significant acute or chronic medical illness.
We found this trial at
21
sites
9200 W Wisconsin Ave
Milwaukee, Wisconsin 53226
(414) 805-3666
Principal Investigator: William Bradley
Phone: 414-805-4763
Froedtert and the Medical College of Wisconsin Froedtert Health combines with the Medical College of...
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3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Principal Investigator: Anne Van Arsdale
Phone: 718-405-8214
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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Bronx, NY
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Jupiter, Florida 33458
Principal Investigator: Donna Pinelli
Phone: 561-263-5791
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Jupiter, FL
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Principal Investigator: Ronald Alvarez
Phone: 800-811-8480
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
Principal Investigator: Anthony Opipari
Phone: 734-763-5492
University of Michigan The University of Michigan was founded in 1817 as one of the...
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Augusta, Georgia 30912
Principal Investigator: Daron Ferris
Phone: 706-721-2535
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Augusta, GA
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Chattanooga, Tennessee 37403
Principal Investigator: Stephen DePasquale
Phone: 423-266-3636
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Principal Investigator: Summer Dewdney
Phone: 312-942-7254
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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Chicago, IL
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Columbus, Ohio 43231
Principal Investigator: Milroy Samuel
Phone: 614-682-5182
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969 Lakeland Drive
Jackson, Mississippi 39216
Principal Investigator: D. Paul Seago
Phone: 601-200-4974
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Kalamazoo, Michigan 49009
Principal Investigator: Roger Beyer
Phone: 269-372-7800
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Kansas City, Kansas
Principal Investigator: Kevin Ault
Phone: 913-588-6287
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630 W 168th St
New York, New York
212-305-2862
Principal Investigator: Ana Tergas
Phone: 212-342-6895
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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Newark, Delaware 19713
Principal Investigator: Mark Borowsky
Phone: 302-623-4450
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Newark, New Jersey 07103
Principal Investigator: Mark Einstein
Phone: 973-972-8367
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1410 North 13th Street
Norfolk, Nebraska 68701
Principal Investigator: Keith Vrbicky
Phone: 605-232-9000
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1100 N. Lindsay
Oklahoma City, Oklahoma 73104
(405) 271-4000
Principal Investigator: Katherine Smith
Phone: 405-271-8001
University of Oklahoma The OU Health Sciences Center is composed of seven health-related colleges located...
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Pittsburgh, Pennsylvania 15213
Principal Investigator: Robert Edwards
Phone: 412-641-3578
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Rio Piedras, 00935
Principal Investigator: Josefina Romaguera
Phone: 787-245-8082
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Scarborough, Maine 04074
Principal Investigator: Christopher Darus
Phone: 207-396-8670
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Winston-Salem, North Carolina 27103
Principal Investigator: Robert Parker
Phone: 866-853-0220
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