High Grade Anal Canal Intraepithelial Neoplasia Clinical Trial
Official title:
HPV Vaccine to Interrupt Progression of Vulvar and Anal Neoplasia (VIVA) Trial: A Randomized, Double-Blind, Placebo-Controlled Trial
This phase IV trial studies how well human papillomavirus (HPV) vaccine therapy works in interrupting progression in patients with high-grade vulvar or anal lesions. Vaccines made from HPV peptides or antigens may help the body build an effective immune response to kill tumor cells and decrease the chance of vulvar or anal lesions to progress or come back.
OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive recombinant human papillomavirus nonavalent vaccine intramuscularly (IM) at baseline, 2 months, and 6 months. ARM II: Patients receive placebo IM at baseline, 2 months, and 6 months. After completion of study treatment, patients are followed up at months 7, 12, 18, 24, 36, and 42. ;