A Study of VGX-3100 DNA Vaccine With Electroporation in Patients With Cervical Intraepithelial Neoplasia Grade 2/3 or 3 (HPV-003)

September 5, 2018 updated by: Inovio Pharmaceuticals

Phase II Placebo Controlled Study of VGX-3100, (HPV16 E6/E7, HPV18 E6/E7 DNA Vaccine) Delivered IM Followed by Electroporation With CELLECTRA-5P for the Treatment of Biopsy-proven CIN 2/3 or CIN 3 With Documented HPV 16 or 18.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

167

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Victoria, Australia, 3052
  • Canada
      • Vancouver, Canada, V5Z-1M9
    • Quebec
      • Montreal, Quebec, Canada, H3A 1A1
  • Estonia
      • Tallinn, Estonia
      • Tartu, Estonia
  • Georgia
      • Batumi, Georgia, 6400
      • Tbilisi, Georgia
  • India
      • Kolkata, India
      • New Delhi, India
      • Pune, India, 411043
    • Karnataka
      • Bangalore, Karnataka, India, 560017
    • Rajasthan
      • Jaipur, Rajasthan, India, 302017
  • Korea, Republic of
      • Seoul, Korea, Republic of
  • Puerto Rico
      • San Juan, Puerto Rico, 00936
  • South Africa
      • Bloemfontein, South Africa, 9301
      • Cape Town, South Africa, 7925
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85015
      • Tucson, Arizona, United States, 85721
    • California
      • Colton, California, United States, 92324
      • La Mesa, California, United States, 91942
      • Los Angeles, California, United States, 90036
    • Colorado
      • Lakewood, Colorado, United States, 80228
    • Florida
      • Boynton Beach, Florida, United States, 33472
      • Fort Lauderdale, Florida, United States, 33316
      • Sarasota, Florida, United States, 34231
    • Maryland
      • Baltimore, Maryland, United States, 21205
    • Michigan
      • Saginaw, Michigan, United States, 48604
    • Montana
      • Missoula, Montana, United States, 59808
    • New York
      • Bronx, New York, United States, 10467
      • Port Jefferson, New York, United States, 11777
    • North Carolina
      • Raleigh, North Carolina, United States, 27607
      • Winston-Salem, North Carolina, United States, 27103
    • Ohio
      • Columbus, Ohio, United States, 43231
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73117
    • Oregon
      • Eugene, Oregon, United States, 97401
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19122
    • South Carolina
      • Myrtle Beach, South Carolina, United States, 29572
    • Utah
      • Murray, Utah, United States, 84107
      • Pleasant Grove, Utah, United States, 84062
      • Sandy, Utah, United States, 84070
    • Virginia
      • Richmond, Virginia, United States, 23233
    • Washington
      • Renton, Washington, United States, 98055
      • Spokane, Washington, United States, 99207

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Female subjects age 18-55 years;
  • Histologically confirmed HPV-16 or HPV-18-associated CIN 2/3 or CIN 3 from tissue collected less than 10 weeks prior to Vaccination/EP #1 with no evidence of invasive cancer in any specimen;
  • Colposcopy is satisfactory based on visualization of the entire squamocolumnar junction and the upper limit of the entire aceto-white or suspected CIN disease area; lesions in ≤ 3 cervical quadrants (4 quadrant disease where the lesion occupies less than 50% of each quadrant will be considered for inclusion);
  • Healthy subjects as judged by the Investigator based on medical history, PE, and normal results for an ECG, CBC, Serum Chemistries, CPK and urinalysis done up to 4 weeks prior to enrollment and administration of study drug;
  • Women of child-bearing potential agree to remain sexually abstinent, use two medically effective methods of contraception (e.g. oral contraception, barrier methods, spermicide, intrauterine device (IUD)), or have a partner who is sterile (i.e., vasectomy) through 36 weeks (9 months);
  • Able and willing to comply with all study procedures and voluntarily signs informed consent form

Exclusion Criteria:

  • Unsatisfactory colposcopy defined as incomplete visualization of the entire squamocolumnar junction and the upper limit of the entire aceto-white or suspected CIN disease area;
  • Pregnancy or breastfeeding
  • Immunosuppression including any concurrent condition requiring the continued use of systemic or topical steroids at or near the injection site [deltoid, upper arm] (excluding inhaled and eye drop-containing corticosteroids) or the use of immunosuppressive agents. All other corticosteroids must be discontinued > 4 weeks prior to Day 0 of study vaccine administration; autoimmune disorders, transplant recipients;
  • History of previous therapeutic HPV vaccination (individuals who have been immunized with licensed prophylactic HPV vaccines (e.g. Gardasil®, Cervarix®) are not excluded);
  • Positive serological test for hepatitis C virus or hepatitis B virus surface antigen(HBsAg) or human immunodeficiency virus (HIV)
  • Administration of any blood product within 3 months of enrollment
  • Administration of any licensed vaccine within 2 weeks of enrollment( 4weeks for measles vaccine)
  • Participation in a study with an investigational compound or device within 30 days of signing informed consent;
  • Cardiac pre-excitation syndromes (such as Wolff-Parkinson-White);
  • History of seizures (unless seizure free for 5 years);
  • Tattoos, scars, or active lesions/rashes within 2 cm of the intended site of vaccination/EP or any implantable leads; or any implantable leads;
  • Active drug or alcohol use or dependence that, in the opinion of the investigator,would interfere with adherence to study requirements;
  • Prisoners or subjects who are compulsorily detained (involuntarily incarcerated)for treatment of either a psychiatric or physical (i.e. infections disease) illness must not be enrolled into this study;
  • Any other conditions judged by the investigator that would limit the evaluation of a subject

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
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.
Biological: Placebo
1ml of placebo delivered IM followed by electroporation at Day 0, Week 4 and Week 12.
EXPERIMENTAL: VGX 3100
Biological: VGX 3100
1ml of VGX-3100 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Histopathological Regression of Cervical Lesions to CIN 1 or Less as a Measure of Efficacy.
Time Frame: 36 weeks
The number of participants with histopathologically confirmed CIN2/3 or CIN 3 associated with HPV16 or HPV18 whose cervical lesions regress to CIN 1 or less at the 36 week visit.
36 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Virologically-proven Clearance of HPV 16 or 18 in Combination with Histopathological Regression of Cervical Lesions to CIN 1 or Less as a Secondary Measure of Efficacy
Time Frame: 36 Weeks
The number of participants with histopathologically confirmed CIN2/3 or CIN 3 associated with HPV16 or HPV18 whose cervical lesions regress to CIN 1 or less and have virologically-proven clearance of HPV16 or HPV18 at the 36 week visit.
36 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inovio Pharmaceuticals

Investigators

  • Principal Investigator: Cornelia Trimble, MD, Johns Hopkins University
  • Principal Investigator: Robert L Parker, Jr., MD, Lyndhurst Gynecologic Associates

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (ACTUAL)

May 1, 2014

Study Completion (ACTUAL)

April 1, 2015

Study Registration Dates

First Submitted

February 16, 2011

First Submitted That Met QC Criteria

February 24, 2011

First Posted (ESTIMATE)

February 25, 2011

Study Record Updates

Last Update Posted (ACTUAL)

September 7, 2018

Last Update Submitted That Met QC Criteria

September 5, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HPV-003

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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