A clinical research study for women with Vulvar Intraepithelial Neoplasia (VIN) Also referred to as VIN 2 or VIN 3, Vulvar Dysplasia, Vulvar HSIL or Pre-Cancerous Lesions of the Vulva

About The Study

Inovio is sponsoring a clinical trial to test the efficacy and safety of an innovative investigational immunotherapy, VGX-3100, in combination with a study device to treat women with pre-cancerous cells of the vulva caused by human papilloma virus (HPV). This novel immunotherapy is being assessed as an alternative to surgery, with the potential of clearing the underlying HPV infection.

How Does It Work?

  • Approximately 36 women (aged 18 or over) will participate in this study.
  • All eligible participants will receive four to six doses of either VGX-3100 or VGX-3100 in combination with topical imiquimod.
  • Study-related procedures and study treatments will be provided at no cost to you.
  • This includes confirmation of VIN and HPV diagnosis.
  • Participation is completely voluntary and you can withdraw at any time.
  • Compensation for time and travel may be available.
I WAS EMOTIONALLY SCARED AND HAD ANXIETY. I HAD A LOT OF PAIN AND I COULDN'T BE VERY ACTIVE. THAT WAS HARD BECAUSE I'M A VERY ACTIVE PERSON AND THE DOCTOR SAID I COULDN'T DO ANYTHING FOR A WHILE. ~ Anonymous *Market research, dated Oct 4, 2016

How does the investigational immunotherapy and device combination work?

The treatment is an investigational immunotherapy called VGX-3100 given by intramuscular injection, followed by electroporation using an investigational device. This novel device delivers a small, controlled electric pulse to increase the amount of the study drug taken up by the muscle. VGX-3100 will act as the blueprint for your body to make proteins and stimulate an immune response to HPV which can help the body “reject” the HPV that has infected your body’s cells. These new proteins can become targets for the body’s immune system to help treat or reduce the existing precancerous cells that could otherwise progress to vulvar cancer.

"Investigational" means the study drug and device combination has not been approved by the U.S Food and Drug Administration (FDA). The study drug and device combination has been tested in two previous studies on women with grade 2 or 3 pre-cancerous cells on the cervix and no serious adverse events (side effects) related to the investigational drug were noted.

FIND A STUDY SITE NEAR YOU
IT WAS STRESSFUL, DEPRESSING, EMBARRASSING, AND PAINFUL. I HAD THESE EMBARRASSING WART-LIKE LESIONS, AND IT WAS VERY PAINFUL DURING INTERCOURSE. ~Anonymous *Market research, dated Oct 4, 2016

WHY SHOULD YOU PARTICIPATE?

1

Access to treatment that can potentially avoid surgical removal of your precancerous lesions

2

Access to treatment that isn't commercially available

3

Regular and close monitoring of your disease from a team of trained medical professionals

4

Contributing to research that may result in future alternatives to treat HPV infections and improve lives

5

Taking control over your situation to seek a better quality of life

6

Treatment is free

DO YOU QUALIFY?

  • Women aged 18 and above
  • Have high grade squamous intraepithelial lesion (HSIL) of the vulva caused by HPV types 16 or 18 *
  • Post-menopausal or surgically sterile or willing to use a contraceptive method until 6 months following the last dose of investigational product.

* If you're not sure if you qualify, please contact a site near you.

FOR MORE INFORMATION, FIND A SITE NEAR YOU:

FLORIDA

JUPITER MEDICAL CENTER

345 Jupiter Lakes Blvd.
Jupiter, FL 33458

CONTACT

Deia Wilkes
561-263-5768
Deia.Wilkes@jupitermed.com

GEORGIA

Augusta University

Womens Health Research Center
1423 Harper St.Suite Hh-1013
Augusta, GA 30912

CONTACT

Angela Gobel
706-721-2535
agoebel@augusta.edu

ILLINOIS

Rush University Medical Center

1725 West Harrison St.
Professional Building,
Suite 829
Chicago, IL 60612

CONTACT

Judith Dybinski
312-942-7254
judith_m_dybinski@rush.edu

KANSAS

University of Kansas Medical Center

3901 Rainbow Blvd.
Kansas City, KS 66160

CONTACT

John Moore
913-588-6287
jmoore20@kumc.edu

MAINE

Maine Medical Center

100 Campus Dr. West
Suite 125
Scarborough, ME 04074-9692

CONTACT

207-396-8670
clinicalresearch@mmc.org

MICHIGAN

Beyer Research

7110 Stadium Drive
Kalamazoo, MI 49009

CONTACT

Lucy Wright Pelletier
269-372-7800
lwpelletier@beyerresearch.com

University of Michigan

1500 East Medical Center Dr.
Ann Arbor, MI 48109-0276

CONTACT

Jill Hayden
734-936-8349
jhayden@med.umich.edu

MISSISSIPPI

St. Dominic-Jackson

Memorial Hospital
971 Lakeland Dr.
Suite 750
Jackson, MS 39216

CONTACT

Regina Outlaw
601-200-4974
outlaw@stdom.com

NEBRASKA

Meridian Clinical Research Norfolk

1410 N 13th St.
Suite 5
Norfolk, NE 68701

CONTACT

Alison Pierce
605-232-9000
apierce@mcrmed.com

NEW JERSEY

Rutgers New Jersey

185 South Orange Ave.
MSB E-506
Newark, NJ 07103

CONTACT

Randall Teeter
973-972-8367
randall.teeter@njms.rutgers.edu

NEW YORK

Columbia University Medical Center

Herbert Irving Pavilion
161 Fort Washington Ave.
2nd Floor, Room 202
New York, NY 10032

CONTACT

Reena M. Vattakalam
212-342-6895
rmv2110@cumc.columbia.edu

Montefiore Medical Center

1695 Eastchester Rd.
Suite 601
Bronx, NY 10461

CONTACT

Melissa Hudson
718-405-8214
mehudson@montefiore.org

NORTH CAROLINA

Lyndhurst Clinical Research

2927 Lyndhurst Ave.
Winston-Salem, NC 27103

CONTACT

336-354-1076

OKLAHOMA

University of Oklahoma

825 NE 10th St.
Suite 3C
Oklahoma City, OK 73104

CONTACT

Gina Herbert
405-271-8001 x48273
gina-herbert@ouhsc.edu

PENNSYLVANIA

Magee Women's Hospital

300 Halket St.
Pittsburgh, PA 15213

CONTACT

Carol Kagemann
412-641-2588
kageca@upmc.edu

PUERTO RICO

Puerto Rico Translational Research Center (PRTRC)

Puerto Rico Clinical & Translational Research Consortium
University District Hospital
First Floor, Medical Center
Rio Piedras, PR 00935

CONTACT

Dr. Josefina Romaguera
787-245-8082
josefina.romaguera@upr.edu

Janice Diaz
787-759-0306
janice.diaz2@upr.edu

OHIO

Complete HealthCare for Women, Inc.

5888 Cleveland Ave.
Columbus, OH 43231

CONTACT

Sudha Suthanthira
614-682-5182
sutha@drsamuel.org

TENNESSEE

Chattanooga's Program In Women's Oncology

102 Central Ave.
Chattanooga, TN 37403

CONTACT

Kim Donelson
423-266-3636
Kimberly.Donelson@erlanger.org

Vanderbilt University Medical Center

1161 21st Ave. South
Nashville, TN 37232

CONTACT

The Eligibility Office
1-800-811-8480

WISCONSIN

Froedtert & Medical

College of Wisconsin
9200 W. Wisconsin Ave.
Milwaukee, WI 53226

CONTACT

Qiana Christian
414-805-4763
qchristian@mcw.edu

FACTS ABOUT VULVAR INTRAEPITHELIAL NEOPLASIA (VIN):

  • HPV-associated vulvar intraepithelial neoplasia (VIN) is a chronic, premalignant disorder of the vulvar skin that is caused by persistent infection with one or more high-risk genotypes of HPV
  • VIN can lead to vulvar cancer with an estimated 6,020 new cases and 1,150 attributable deaths annually for year 2017 in the United States
  • Symptoms of VIN can include persistent itching, soreness, tingling or burning in the vulva, changes to the way your skin looks around your vulva and pain during sex
  • Risk factors for VIN include HPV infection and cigarette smoking
  • Women with VIN are at risk of recurrent disease and vulvar cancer throughout their lives.
    • Surveillance is 6 and 12 months after treatment, then annual visual inspection of the vulva
  • Treatment is recommended for all women with HPV-Related VIN
  • HPV-16/18 is involved in about 83% of HPV-associated VIN cases in the U.S.
  • VIN remains a significantly undermet medical condition for the following reasons:
    1. The rate of recurrence of VIN under currently used surgical and medical approaches is high
    2. There is a high psychological and physical negative impact of surgery
    3. VIN may impact activities of daily living
    4. Prophylactic HPV vaccines have no therapeutic activity against VIN and have not achieved universal uptake, leaving a population of susceptible and impacted women
    5. The early diagnosis of VIN is limited to visual inspection with biopsy