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REVEAL 2 Trial (Evaluation of VGX-3100 and Electroporation for the Treatment of Cervical HSIL)

NCT03721978 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 203

Last updated 2024-10-17

Study results available
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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.

Conditions

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

Interventions

BIOLOGICAL

VGX-3100

1 milliliter (mL) VGX-3100 injected IM.

BIOLOGICAL

Matched Placebo

1 mL of matched Placebo injected IM.

DEVICE

CELLECTRA™-5PSP

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

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
2019-02-28
Primary Completion
2022-08-23
Completion
2022-09-15
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States
  • Argentina
  • Brazil
  • Estonia
  • Finland
  • Lithuania
  • Poland
  • Puerto Rico
  • South Africa
  • Spain

Study Locations

More Related Trials

Entities

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 NCT03721978 on ClinicalTrials.gov