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)
Public ClinicalTrials.gov record NCT03180684. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT03180684
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 33 participants
Conditions and interventions
Conditions
Interventions
- VGX-3100 Biological
- Imiquimod 5% Cream Drug
- CELLECTRA™ 2000 Device
Biological · Drug · Device
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 31, 2017 (Actual)
- Primary completion
- Jul 23, 2020 (Actual)
- Completion
- Dec 18, 2020 (Actual)
- Last update posted
- Aug 25, 2023
2017 – 2020
United States locations
- U.S. sites
- 15
- U.S. states
- 13
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Christiana Care Health Systems | Newark | Delaware | 19713 | — |
| Augusta University | Augusta | Georgia | 30912 | — |
| Rush University Medical Center | Chicago | Illinois | 60612 | — |
| Maine Medical Center | Scarborough | Maine | 04074 | — |
| University of Michigan | Ann Arbor | Michigan | 48109 | — |
| St. Dominic Hospital | Jackson | Mississippi | 39216 | — |
| Rutgers New Jersey | Newark | New Jersey | 07103 | — |
| Columbia University Medical Center | New York | New York | 10032 | — |
| Montefiore Medical Center | The Bronx | New York | 10461 | — |
| Lyndhurst Clinical Research | Winston-Salem | North Carolina | 27103 | — |
| Complete HealthCare for Women, Inc. | Columbus | Ohio | 43231 | — |
| University of Pittsburgh Medical Center - Magee Womens Hospital | Pittsburgh | Pennsylvania | 15213 | — |
| Chattanooga's Program in Women's Oncology | Chattanooga | Tennessee | 37403 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232-2519 | — |
| Froedtert and The Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03180684, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 25, 2023 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03180684 live on ClinicalTrials.gov.