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Treatment Study for Patients with Vulvar Lesion Due to HPV
The purpose of this study is to test the safety and efficacy of an investigational immunotherapy VGX-3100, in combination with a study device, to treat women with vulvar high grade squamous intraepithelial lesion (HSIL) (VIN 2 or VIN 3) associated with HPV types 16 and/or 18. VGX-3100 is being assessed as an alternative to surgery with the potential to clear the underlying HPV infection.
In order to participate you must meet the following criteria:
- Understand, agree and be able to comply with the requirements of the protocol. Subjects must be willing and able to provide voluntary consent to participate and sign a consent form prior to study-related activities.
- Are a woman 18 years of age and above.
- Have a vulvar infection with HPV types 16 and/or 18 confirmed by screening biopsy.
- Have vulvar tissue specimen/blocks that have been collected within 10 weeks prior to anticipated date of first dose of study drug and have histologically confirmed vulvar HSIL by the Pathology Adjudication Committee at screening.
You will be excluded from the study if any of the following criteria apply to you:
- Have untreated microinvasive or invasive cancer.
- Have biopsy-proven vaginal intraepithelial neoplasia (VAIN) and are not undergoing medical care and/or treatment for VAIN.
- Have biopsy-proven anal intraepithelial neoplasia (AIN) and are not undergoing medical care and/or treatment for AIN.
- Have biopsy-proven cervical intraepithelial neoplasia (CIN) 2/3 and are not undergoing medical care and/or treatment for CIN.
This is a partial list of inclusion and exclusion criteria.