Trials / Completed
CompletedNCT03180684
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)
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 33 (actual)
- Sponsor
- Inovio Pharmaceuticals · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Conditions
- Vulvar High Grade Squamous Intraepithelial Lesion (HSIL)
- Vulvar Dysplasia
- Vulvar Intraepithelial Neoplasia (VIN)
- VIN2
- VIN3
- Pre-cancerous Lesions of the Vulva
- Human Papillomavirus (HPV)
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | VGX-3100 | 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. |
| DRUG | Imiquimod 5% Cream | Participants applied imiquimod 5% cream to the vulvar lesion three times per week for 20 weeks. |
| DEVICE | CELLECTRA™ 2000 | IM injection of VGX-3100 was followed by EP with the CELLECTRA™ 2000 device. |
Timeline
- Start date
- 2017-08-31
- Primary completion
- 2020-07-23
- Completion
- 2020-12-18
- First posted
- 2017-06-08
- Last updated
- 2023-08-25
- Results posted
- 2023-08-25
Locations
15 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03180684. Inclusion in this directory is not an endorsement.