Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Human Papillomavirus (HPV) | — | UNRESOLVED | — |
| Pre-cancerous Lesions of the Vulva | — | UNRESOLVED | — |
| VIN2 | — | UNRESOLVED | — |
| VIN3 | — | UNRESOLVED | — |
| Vulvar Dysplasia | Vulvar Intraepithelial Neoplasia | ALIAS | 0.90 |
| Vulvar High Grade Squamous Intraepithelial Lesion (HSIL) | High Grade Vulvar Squamous Intraepithelial Lesion | ALIAS | 0.85 |
| Vulvar Intraepithelial Neoplasia (VIN) | Vulvar Intraepithelial Neoplasia | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CELLECTRA™ 2000 | Device | — | UNRESOLVED |
| Imiquimod 5% Cream | Drug | Imiquimod | ALIAS |
| VGX-3100 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- VGX-3100 + EP
- description
- Participants with histologically confirmed vulvar high-grade squamous intraepithelial lesion (HSIL) associated with human papilloma virus (HPV) 16 and/or 18, received four doses of 6 mg VGX-3100 as an intramuscular (IM) injection on Day 0, Week 4, Week 12, and Week 24 followed by electroporation (EP) using the CELLECTRA™ 2000 device. Participants with vulvar HSIL who had a reduction in lesion size or no increase in lesion size at Week 48, received a fifth dose of VGX-3100 at Week 52.
- interventionNames
- Biological: VGX-3100
- Device: CELLECTRA™ 2000
- type
- EXPERIMENTAL
- label
- VGX-3100 + EP + Imiquimod
- description
- Participants with histologically confirmed vulvar HSIL associated with HPV-16 and/or 18, received four doses of 6 mg VGX-3100 as an IM injection on Day 0, Week 4, Week 12, and Week 24 followed by EP using the CELLECTRA™ 2000 device. Participants with vulvar HSIL who had a reduction in lesion size or no increase in lesion size at Week 48, received a fifth dose of VGX-3100 at Week 52. In addition, participants applied imiquimod 5% cream to the vulvar lesion three times per week for 20 weeks.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available