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Effect of Prior 9-Valent Human Papillomavirus Vaccination on Subsequent Lower Genital Tract Dysplasia After Cervical
Elmar Joura1, Susanne K Kjaer, Oliver Bautista
1Department of Gynecology and Obstetrics, Comprehensive Cancer Center, Medical University Vienna, Vienna, Austria; the Unit of Virus, Lifestyle & Genes, Danish Cancer Institute, and Department of Gynecology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark; Merck & Co, Inc, Rahway, New Jersey; and the Moffitt Cancer Center and Research Institute, Tampa, Florida.
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); HPV31/33/45/52/58-related SIL incidence was reduced by 86.3% (95% CI, 47.5-97.8%) with 9vHPV vaccine compared with 4vHPV vaccine (2.7 vs 19.4/1,000 person-years, respectively). The incidence of high-grade SIL was numerically lower in the 9vHPV vaccine group relative to control, but this was not statistically significant (HPV6/11/16/18 related 69.6% reduction [95% CI, -133.5% to 98.7%]; HPV31/33/45/52/58 related 82.7% [95% CI, -29.2% to 99.2%]).
Conclusion:
Among female trial participants who underwent cervical excisional surgery, prior vaccination with 9vHPV vaccine (ie, 0.1-4.4 years before surgery) reduced the incidence of subsequent cervical and lower genital tract dysplasia.
Clinical Trial Registration:
ClinicalTrials.gov , NCT00543543, NCT00092521, NCT00092534.
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