At a glance
ClinicalIndex Comparison Record- ✓Age 18 years or older
- ✓High-grade squamous intraepithelial lesion (HSIL) of the vulva (VIN2 or VIN3)
- ✓HPV-16 and/or HPV-18 infection confirmed at screening
- ✕Biopsy-proven differentiated VIN
- ✕Prior treatment for vulvar HSIL within 4 weeks of screening
- ✕Allergy to imiquimod 5% cream or inactive ingredients
- ✕Pregnant, breastfeeding, or planning pregnancy within 6 months after last study dose
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating VGX-3100, Imiquimod 5% Cream, and 1 other intervention for Vulvar High Grade Squamous Intraepithelial Lesion (HSIL) and 6 related conditions. Completed, enrolled 33 participants across 15 sites.
Detailed 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 high-grade squamous intraepithelial lesion (HSIL) \[vulval intraepithelial neoplasia 2 or 3 (VIN 2 or VIN 3)\] associated with human papilloma virus (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
Study Details
Timeline
Interventions
One milliliter (1 mL) VGX-3100 injected IM and delivered by EP using CELLECTRA™ 2000 on Day 0, Week 4, Week 12 and Week 24.
Participants applied imiquimod 5% cream to the vulvar lesion three times per week for 20 weeks.
IM injection of VGX-3100 was followed by EP with the CELLECTRA™ 2000 device.