Trials / Completed
CompletedNCT03721978
REVEAL 2 Trial (Evaluation of VGX-3100 and Electroporation for the Treatment of Cervical HSIL)
A Prospective, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of VGX-3100 Delivered Intramuscularly Followed by Electroporation With CELLECTRA™ 5PSP for the Treatment of HPV-16 and/or HPV-18 Related High Grade Squamous Intraepithelial Lesion (HSIL) of the Cervix
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 203 (actual)
- Sponsor
- Inovio Pharmaceuticals · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
HPV-303 is a prospective, randomized, double-blind, placebo-controlled study of VGX-3100 delivered intramuscularly (IM) followed by electroporation (EP) delivered with CELLECTRA™ 5PSP in adult women with histologically confirmed high-grade squamous intraepithelial lesions (HSIL) (cervical intraepithelial neoplasia grade 2 \[CIN2\] or grade 3 \[CIN3\]) of the cervix, associated with human papillomavirus (HPV-16) and/or HPV-18.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | VGX-3100 | 1 milliliter (mL) VGX-3100 injected IM. |
| BIOLOGICAL | Matched Placebo | 1 mL of matched Placebo injected IM. |
| DEVICE | CELLECTRA™-5PSP | CELLECTRA™-5PSP used for EP following IM injection of VGX 3100. |
Timeline
- Start date
- 2019-02-28
- Primary completion
- 2022-08-23
- Completion
- 2022-09-15
- First posted
- 2018-10-26
- Last updated
- 2024-10-17
- Results posted
- 2024-10-17
Locations
53 sites across 10 countries: United States, Argentina, Brazil, Estonia, Finland, Lithuania, Poland, Puerto Rico, South Africa, Spain
Regulatory
- FDA-regulated drug study
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03721978. Inclusion in this directory is not an endorsement.