CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 23 enrolled
Drug / intervention
VGX-3100 +1 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/NCT03499795
NCT03499795Phase 2Completed
CompareCT.gov

A Phase 2, Open Label, Study of VGX-3100 Delivered Intramuscularly (IM) Followed by Electroporation (EP) for the Treatment of HPV-16 and/or HPV-18 Related Anal or Anal/Peri-Anal, High Grade Squamous Intraepithelial Lesion (HSIL), (AIN2, AIN3, PAIN2, PAIN3) in Individuals That Are Seronegative for Human Immunodeficiency Virus (HIV)-1/2

Inovio Pharmaceuticals·interventional·Posted Apr 17, 2018·Updated Jul 14, 2023

In Brief

A Phase 2 clinical trial evaluating VGX-3100 and CELLECTRA™ 5PSP for Anal Neoplasm. Completed, enrolled 23 participants across 3 sites in 2 countries.

Detailed Summary

This is a phase 2, open-label efficacy study of VGX-3100 administered by intramuscular (IM) injection followed by electroporation (EP) in adult men and women who are human immunodeficiency virus (HIV) negative with histologically confirmed anal or anal/peri-anal high-grade squamous intraepithelial lesion (HSIL) associated with human papilloma virus (HPV)-16 and/or HPV-18. Approximately 24 participants will receive at least 3 doses of VGX-3100.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnal Neoplasm
CountriesCanada, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedApr 17, 2018
Enrollment StartMay 15, 2018
Primary CompletionJun 16, 2020
Study CompletionMay 26, 2021
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 8.2 years ago

Interventions

VGX-3100biological

One milliliter (1 mL) VGX-3100 (deoxyribonucleic acid \[DNA\] plasmids encoding E6 and E7 proteins of HPV types 16 and 18) will be injected IM and delivered by EP using CELLECTRA™ 5PSP on Day 0, Week 4 and Week 12, and potentially Week 40.

CELLECTRA™ 5PSPdevice

IM injection of VGX-3100 is followed by EP with the CELLECTRA™ 5PSP device.