Phase 2 Clinical Trial Evaluating Secondary HPV Vaccination After Treatment of High-grade Cervical Lesions (HPV2-2303)

What this Trial Is About

Researchers are evaluating the effects of secondary HPV vaccination in women over 45 years old who have been treated for high-grade cervical lesions and are chronic carriers of HPV. This Phase II interventional study aims to estimate how many of these women clear HPV within two years after an initial positive HPV control test. It also explores vaccination safety, recurrence of lesions, and incidence of invasive gynecological cancers, comparing vaccinated women to those who decline vaccination and receive standard care. The study includes two groups: vaccinated patients receiving the nonavalent HPV vaccine, Gardasil 9, administered in three doses over one year (first dose on day 1, second dose two months later, third dose four months after the second) as part of an interventional trial; and non-vaccinated patients who continue with standard care in an observational cohort. Vaccinated patients are followed closely during the vaccination schedule and for safety monitoring. Participants will undergo HPV testing and control colposcopies as per standard surveillance. Researchers will assess HPV clearance rates within two years and monitor viral dynamics annually for up to five years. They will also evaluate adverse events during vaccination, lesion recurrence, and invasive cancer incidence. Compliance with vaccination timing and number of doses will be tracked. The total study duration includes vaccination over one year and follow-up assessments up to five years.

Clinical Trial Evaluating Secondary HPV Vaccination After Treatment of High-grade Cervical Lesions