***JBR Clinical Research is not accepting new applicants for this study at this time. If you would like to be considered for other studies, please submit a form on our Healthy Volunteers Study page or call us at 801-261-2000. Thank you!***
Women aged 18-55, with abnormal Pap smear or abnormal biopsy and HPV 16 or 18 positive may be eligible for this research study.
The study involves an experimental vaccine in combination with a device that will deliver a small electric charge to help increase your body’s immune response.
There will be 12 visits and all study related procedures will be provided to you at no cost. In addition, you will be closely monitored for safety during the course of the trial.
For more information about this study, please fill out the form or you may contact:
Dr. Elizabeth Graul
Purpose of the Study
This study is being done to see how well an investigational new drug and study device combination will work to treat people with precancerous cells on the cervix caused by human papillomavirus (HPV).
The study drug and device combination has been tested in two previous studies on women with grade 2 or 3 precancerous cells on the cervix and no serious problems were noted.
At least five other studies have been started in humans to deliver other drugs using the same study device that will be used in this study without serious problems.
The purpose of this study is to test the study drug (called VGX-3100) to see if it will help remove or shrink cervical lesions in women with grade 2 or 3 precancerous cells on the cervix by making the bodys immune response to HPV stronger.
In this research study we are studying how to activate your immune system with VGX-3100 by using gene-based therapy. Gene-based therapy involves inserting VGX-3100 which contains specially designed genes into your muscle. A gene is a part of the genetic code that instructs the cells of our bodies to produce specific compounds (proteins) important for the makeup or function of the cell.
What Will Happen During the HPV Study
Screening: You can participate if you have been diagnosed with grade 2 or 3 precancerous cells on your cervix. A colposcopy may need to be performed in order to collect more tissue form your cervix.
Colposcopy: This test will be performed during the study to monitor for the presence of precancerous cells on your cervix. The colposcopy procedure is similar to the Pap smear.
How do people get HPV?
HPV is passed on through genital contact, most often during vaginal and anal sex. HPV may also be passed on during oral sex and genital-to-genital contact. HPV can be passed on between straight and same-sex partnerseven when the infected partner has no signs or symptoms.
A person can have HPV even if years have passed since he or she had sexual contact with an infected person. Most infected persons do not realize they are infected or that they are passing the virus on to a sex partner. It is also possible to get more than one type of HPV.
Rarely, a pregnant woman with genital HPV can pass HPV to her baby during delivery. Very rarely, the child can develop juvenile-onset recurrent respiratory papillomatosis (JORRP).
How does HPV cause genital warts and cancer?
HPV can cause normal cells on infected skin to turn abnormal. Most of the time, you cannot see or feel these cell changes. In most cases, the body fights off HPV naturally and the infected cells then go back to normal. But in cases when the body does not fight off HPV, HPV can cause visible changes in the form of genital warts or cancer. Warts can appear within weeks or months after getting HPV. Cancer often takes years to develop after getting HPV.
How common are HPV and related diseases?
HPV (the virus). Approximately 20 million Americans are currently infected with HPV. Another 6 million people become newly infected each year. HPV is so common that at least 50% of sexually active men and women get it at some point in their lives.
(Information about HPV provided by the Center for Disease Control website)