HPV Vaccine Therapy in Interrupting Progression in Patients with High-Grade Vulvar or Anal Lesions

Inclusion Criteria

• Histologically confirmed diagnosis of initial or recurrent anal or vulvar high-grade squamous intraepithelial lesion (AIN2/3 or VIN2/3) diagnosed on or after 1/1/2014; 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
• 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 >= 2 months after therapy
• Resident in the catchment area of the clinics and willing to attend up to 8 clinic visits for a 36-month period
• 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 continuously for at least 6 months prior to enrollment
• Ability to give informed consent
• Willingness to sign medical records release form and tissue release form

Exclusion Criteria

• 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 (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, except the Anal Cancer HSIL Outcomes Research (ANCHOR) study (NCT02135419)
• 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