HARE-40 is a phase I/II vaccine dose escalation study with two different arms: Arm 1A will
perform intrapatient dose escalation in patients with previously treated HPV16+ Head & Neck
Cancer using two dose cohorts to establish a safe, tolerable and recommended dose of HPV
vaccine.
Arm 1B will perform intrapatient dose escalation in patients with advanced HPV16+ cancer
(head and neck, anogenital, penile or cervical) using a single cohort to establish a safe,
tolerable and recommended dose of HPV vaccine.