This study evaluates the impact on disease relapse of presurgical 9-valent HPV vaccination versus placebo vaccination in women treated with LEEP (loop electrosurgical excision procedure) for CIN2+ (high grade cervical intraepithelial neoplasia) and initially invasive cervical cancer.
Patients aged ≥ 18 and ecog performance status ≤ 1
Patients with a diagnosis of high-grade cervical intraepithelial neoplasia or initially invasive cervical cancer (histological results ≥ CIN2 + and ≤ Ia1 according to the FIGO staging of cervical cancer)
No fever at the time of vaccination
No previous HPV vaccination
Patients enrolled in other clinical studies
History of allergic reaction or serious adverse events to previous vaccinations
Positive pregnancy test at the time of vaccination
Patient in treatment with immunosuppressive therapy
Alessandro Ghelardi
Lead sponsor
Azienda USL Toscana Nord Ovest
Sponsor institution