Ricerc@Sapienza

Background. Currently licensed HPV vaccines have an established role in the primary prevention of HPV-related cancers in younger populations. Despite the remarkable impact on public health outcomes worldwide, the HPV vaccination is not recommended for older adults or those with prior HPV exposure, leaving a large portion of the population at risk for recurrent HPV-related diseases. As no vaccine has yet been approved for therapeutic use, increasing interest has been raised for the putative role of the HPV vaccination as adjuvant to the standard treatment in infected patients.
Objective. To investigate the effectiveness of adjuvant HPV vaccination for secondary prevention in patients with active HPV-related disease across different susceptible organ sites.
Design, setting, and participants. This is a trial protocol for a single-institution, multidisciplinary, randomized-controlled clinical trial. Eligible participants have a diagnosis of recurrent active HPV-related disease and will be randomized to receive or not HPV vaccination as part of their treatment. Target enrollment is 264 individuals (case-control 1:1). The primary outcome is the disease recurrence rate. Secondary outcomes include time to recurrence, disease burden, and intersurgical interval. Differences in the risk for recurrence will be evaluated using Cox proportional hazard models. Participants will be followed up for up to 36 months.
Discussion. Rediscovering the role of prophylactic HPV vaccines in the secondary prevention setting paves the way to a new era in the management of HPV-related diseases. Results from this study will provide evidence on whether incorporating adjuvant HPV vaccination into routine care can decrease disease recurrence.