Clinical Trials Directory

Trials / Completed

CompletedNCT03185013

REVEAL 1 (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
201 (actual)
Sponsor
Inovio Pharmaceuticals · Industry
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

Summary

HPV-301 is a prospective, randomized, double-blind, placebo controlled Phase 3 study to determine the efficacy, safety, and tolerability of VGX-3100 administered by intramuscular (IM) injection followed by electroporation (EP) delivered with CELLECTRA™ 5PSP in adult women with histologically confirmed cervical high grade squamous intraepithelial lesion (HSIL) (cervical intraepithelial neoplasia grade 2 \[CIN2\] or grade 3 \[CIN3\]) associated with human papillomavirus (HPV) 16 and/or HPV-18.

Conditions

Interventions

TypeNameDescription
BIOLOGICALVGX-31001 mL VGX-3100 will be injected IM and delivered by EP using CELLECTRA™-5PSP on Day 0, Week 4 and Week 12.
BIOLOGICALPlacebo1 mL of Placebo will be injected IM and delivered by EP using CELLECTRA™-5PSP on Day 0, Week 4 and Week 12.
DEVICEElectroporation (EP)Intramuscular injection followed by EP with the CELLECTRA™ 5PSP device.

Timeline

Start date
2017-06-28
Primary completion
2020-07-08
Completion
2021-04-06
First posted
2017-06-14
Last updated
2023-07-27
Results posted
2023-07-25

Locations

60 sites across 19 countries: United States, Argentina, Belgium, Estonia, Finland, Germany, Italy, Lithuania, Mexico, Peru, Philippines, Poland, Portugal, Puerto Rico, Slovakia, South Africa, Spain, Thailand, United Kingdom

Regulatory

Source: ClinicalTrials.gov record NCT03185013. Inclusion in this directory is not an endorsement.