CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 203 enrolled
Drug / intervention
VGX-3100 +2 morebiological
Likely dose
Matched Placebo 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/NCT03721978
NCT03721978Phase 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 Oct 26, 2018·Updated Oct 17, 2024

In Brief

A Phase 3 clinical trial evaluating VGX-3100, Matched Placebo, and 1 other intervention for Cervical Dysplasia and 2 related conditions. Completed, enrolled 203 participants across 53 sites in 10 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCervical Dysplasia, Cervical High Grade Squamous Intraepithelial Lesion, HSIL
CountriesArgentina, Brazil, Estonia, Finland, Lithuania, Poland, Puerto Rico, South Africa, Spain, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedOct 26, 2018
Enrollment StartFeb 28, 2019
Primary CompletionAug 23, 2022
Study CompletionSep 15, 2022
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 7.7 years ago

Interventions

VGX-3100biological

1 milliliter (mL) VGX-3100 injected IM.

Matched Placebobiological

1 mL of matched Placebo injected IM.

CELLECTRA™-5PSPdevice

CELLECTRA™-5PSP used for EP following IM injection of VGX 3100.