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REVEAL 1 (Evaluation of VGX-3100 and Electroporation for the Treatment of Cervical HSIL)

NCT03185013 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 201

Last updated 2023-07-27

Study results available
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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

  • Cervical Dysplasia
  • Cervical High Grade Squamous Intraepithelial Lesion
  • HSIL

Interventions

BIOLOGICAL

VGX-3100

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

BIOLOGICAL

Placebo

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

DEVICE

Electroporation (EP)

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

Sponsors & Collaborators

Principal Investigators

  • Jeffrey Skolnik, MD · Inovio Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-28
Primary Completion
2020-07-08
Completion
2021-04-06
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States
  • Argentina
  • Belgium
  • Estonia
  • Finland
  • Germany
  • Italy
  • Lithuania
  • Mexico
  • Peru
  • Philippines
  • Poland
  • Portugal
  • Puerto Rico
  • Slovakia
  • South Africa
  • Spain
  • Thailand
  • United Kingdom

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03185013 on ClinicalTrials.gov