Effect of Prior 9-Valent Human Papillomavirus Vaccination on Subsequent Lower Genital Tract Dysplasia After Cervical Excisional Surgery

作者：Elmar A. Joura, Susanne K. Kjær, Oliver Bautista, Alain Luxembourg, Alfred J. Saah, Anna R. Giuliano · 发表于：Obstetrics and Gynecology · 年份：2025 · DOI：10.1097/aog.0000000000006113 · 被引用次数：7 · 研究领域：Cervical Cancer and HPV Research、Endometrial and Cervical Cancer Treatments、Reproductive tract infections research

OBJECTIVE: To assess the efficacy of prior 9-valent human papillomavirus (9vHPV) vaccination on risk of subsequent cervical, vaginal, and vulvar disease after a cervical excisional procedure for cervical squamous intraepithelial lesion (SIL) in a retrospective clinical trial analysis. METHODS: Women aged 16-26 years were randomized to three-dose regimens of 9vHPV vaccine, quadrivalent HPV (4vHPV) vaccine, or placebo in three double-blind efficacy trials: a study of 9vHPV vaccine compared with 4vHPV vaccine ( ClinicalTrials.gov , NCT00543543) and two historic placebo-controlled 4vHPV vaccine studies ( ClinicalTrials.gov , NCT00092521 and NCT00092534). Incidence of subsequent condyloma, cervical, vulvar, or vaginal SIL was compared between 9vHPV vaccine and controls in women who underwent cervical excisional surgery after vaccination and had 6 months or more of follow-up after surgery. For HPV31/33/45/52/58-related endpoints, the control group was 4vHPV vaccine (from 9vHPV vaccine trial); for HPV6/11/16/18 analysis, the control group was historic placebo (from 4vHPV vaccine trials). RESULTS: This analysis included 295 9vHPV vaccine, 722 4vHPV vaccine, and 493 historic placebo recipients who underwent cervical surgery after a median of 1.7 years (range 0.1-4.4 years) after dose 1. Subsequent to surgery, HPV6/11/16/18-related SIL incidence was reduced by 95.4% (95% CI, 74.7-99.8%) with prior 9vHPV vaccine relative to historic placebo (1.3 vs 29.0/1,000 person-years, respectively)...