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)
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)
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.