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. ”
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. ”
WHY SHOULD YOU PARTICIPATE?1
Access to treatment that can potentially avoid surgical removal of your precancerous lesions2
Access to treatment that isn't commercially available3
Regular and close monitoring of your disease from a team of trained medical professionals4
Contributing to research that may result in future alternatives to treat HPV infections and improve lives5
Taking control over your situation to seek a better quality of life6
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:
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:
- The rate of recurrence of VIN under currently used surgical and medical approaches is high
- There is a high psychological and physical negative impact of surgery
- VIN may impact activities of daily living
- Prophylactic HPV vaccines have no therapeutic activity against VIN and have not achieved universal uptake, leaving a population of susceptible and impacted women
- The early diagnosis of VIN is limited to visual inspection with biopsy