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: Completed
• Trial end date: 2020-12-18
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Inovio Pharmaceuticals
• Treatments: Imiquimod

Criteria

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.