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A Study of VGX-3100 DNA Vaccine With Electroporation in Patients With Cervical Intraepithelial Neoplasia Grade 2/3 or 3

NCT01304524 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 167

Last updated 2018-09-07

No results posted yet for this study

Summary

This is randomized, placebo controlled study to determine safety and efficacy of VGX-3100 DNA Vaccine delivered by Electroporation to adult women with biopsy-proven HPV 16 or 18 associated Cervical intraepithelial neoplasia grade 2/3 or 3.

Conditions

  • Cervical Intraepithelial Neoplasia

Interventions

BIOLOGICAL

VGX 3100

1ml of VGX-3100 delivered IM followed by electroporation at Day 0, Week 4 and Week 12.

BIOLOGICAL

Placebo

1ml of placebo delivered IM followed by electroporation at Day 0, Week 4 and Week 12.

DEVICE

CELLECTRA™-5P

CELLECTRA™-5P is used for electroporation following IM delivery of VGX 3100 or placebo on Day 0, Week 4 and Week 12.

Sponsors & Collaborators

Principal Investigators

  • Cornelia Trimble, MD · Johns Hopkins University

  • Robert L Parker, Jr., MD · Lyndhurst Gynecologic Associates

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2014-05-31
Completion
2015-04-30
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States
  • Australia
  • Canada
  • Estonia
  • Georgia
  • India
  • Puerto Rico
  • South Africa
  • South Korea

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 NCT01304524 on ClinicalTrials.gov