CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 201 enrolled
Drug / intervention
VGX-3100 +2 morebiological
Likely dose
VGX-3100 1 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03185013
NCT03185013Phase 3Completed
CompareCT.gov

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

Inovio Pharmaceuticals·interventional·Posted Jun 14, 2017·Updated Jul 27, 2023

In Brief

A Phase 3 clinical trial evaluating VGX-3100, Placebo, and 1 other intervention for Cervical Dysplasia and 2 related conditions. Completed, enrolled 201 participants across 60 sites in 19 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCervical Dysplasia, Cervical High Grade Squamous Intraepithelial Lesion, HSIL
CountriesArgentina, Belgium, Estonia, Finland, Germany, Italy, Lithuania, Mexico, Peru, Philippines, Poland, Portugal, Puerto Rico, Slovakia, South Africa, Spain, Thailand, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedJun 14, 2017
Enrollment StartJun 28, 2017
Primary CompletionJul 8, 2020
Study CompletionApr 6, 2021
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 9.0 years ago

Interventions

VGX-3100biological

1 mL VGX-3100 will be injected IM and delivered by EP using CELLECTRA™-5PSP on Day 0, Week 4 and Week 12.

Placebobiological

1 mL of Placebo will be injected IM and delivered by EP using CELLECTRA™-5PSP on Day 0, Week 4 and Week 12.

Electroporation (EP)device

Intramuscular injection followed by EP with the CELLECTRA™ 5PSP device.