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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
188
Correlative studies
Given IM
Ancillary studies
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
Persistent High-risk Infection Among Vaccine Compared With Placebo Recipients
Persistence will be measured as two or more consecutive polymerase chain reaction (PCR) positive swabs for the same human papillomavirus (HPV) genotype. Will use Chi-Square test to compare the number of participants with the persistent infection in the vaccinated to unvaccinated group.
Time frame: Up to month 36
Time to Recurrence of Anogenital High Grade Squamous Intraepithelial Lesion (HSIL)
Will compare vaccine and placebo recipients. Will evaluate differences in the hazard of recurrence using Cox proportional hazards in the intention to treat population and the per protocol population.
Time frame: Up to month 36
Incidence of Adverse Events (AEs) Via Solicited Vaccine Reactogenicity by Arm
Will monitor safety by comparing type and frequency of AEs in the two study arms, graded according to the Food and Drug Administration criteria. Symptoms are reported at least once from any dose.
Time frame: Up to month 36
HPV Antibody Level
Will evaluate placebo and vaccine recipients separately. Will assess whether presence and amount of HPV antibody, detected at baseline in the placebo arm, is protective against recurrence. For the vaccine arm, will assess whether magnitude of vaccine antibody levels month 1 following the third vaccination in the vaccine arm affects recurrence.
Time frame: Up to month 36
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Given IM