HPV Vaccine to Interrupt Progression of Vulvar and Anal Neoplasia (VIVA) Clinical Trial: A Randomized, Double-Blind, Placebo-Controlled Trial
Ages Eligible for Study: 27 Years to 69 Years (Adult, Senior)
Sexes Eligible for Study: All
- Age 27- 69 at diagnosis of HSIL
- Histologically confirmed diagnosis of anal or vulvar high-grade squamous intraepithelial lesion (HSIL) (anal intraepithelial neoplasia [AIN]2/3-vulvar intraepithelial neoplasia [VIN]2/3); study pathologist will use p16 staining as needed to rule out low-grade squamous intraepithelial lesion (LSIL) disease
- >= 2 months since last therapy for HSIL, diagnosed on or after 1/1/2014
- No clinical evidence of HSIL on screening examination; if HSIL is suspected, a biopsy will be done to exclude HSIL; patients whose screening visit reveals HSIL on biopsy, may be re-screened one time, >= 2 months after therapy
- Resident in the area and willing to attend up to 7 clinic visits for a 36-month period at the Virology Research Clinic (VRC)
- Sexually active women of child-bearing potential must be willing to use effective contraception through month 7 of the study
- If human immunodeficiency virus (HIV) positive, receipt of anti-retroviral therapy for at least 6 months
- Ability to give informed consent
- Willingness to sign medical records release form and tissue release form
Other eligibility criteria may apply.
- Currently pregnant
- Chemotherapy (current, within the last month, or anticipated in the next 7 months)
- Prior history of invasive HPV-related anogenital cancer (cervical, vaginal, vulvar, penile, or anal cancer), or oropharyngeal cancer (throat, base of tongue, tonsil); prior cancer at other sites (including most of oral cavity) or larynx are not exclusions
- Unstable medical condition (e.g., another malignancy requiring treatment, malignant hypertension, poorly controlled diabetes, another cancer except for fully excised non-melanoma skin cancer)
- Prior HPV vaccination
- Known allergy or intolerance to lidocaine
- Currently participating in an interventional research study related to HPV
- Any other condition which, in the opinion of the investigator, may compromise the subject's ability to follow study procedures and safely complete the study
Other exclusion criteria may apply.