Elsevier

Gynecologic Oncology

Volume 154, Issue 1, July 2019, Pages 110-117
Gynecologic Oncology

Nine-valent HPV vaccine efficacy against related diseases and definitive therapy: comparison with historic placebo population,☆☆

https://doi.org/10.1016/j.ygyno.2019.03.253Get rights and content
Under a Creative Commons license
open access

Highlights

  • The 9vHPV vaccine prevents 98% of high-grade cervical dysplasia related to the 9 HPV types covered by the vaccine.

  • The 9vHPV vaccine prevents 98% of cervical surgeries related to the 9 HPV types covered by the vaccine.

  • Vaccine did not prevent diseases related to HPV types detected at baseline but reduced diseases related to other HPV types.

  • While early vaccination in HPV naïve persons is best, sexually active persons may benefit from catch-up vaccination programs.

  • These data will be important to inform future public health vaccination recommendations.

Abstract

Objective

Nine-valent human papillomavirus (9vHPV) vaccine efficacy against disease and cervical surgeries related to all nine vaccine components was assessed compared with a historic placebo population. This was not assessed in the 9vHPV vaccine efficacy trial since the trial was quadrivalent HPV (qHPV) vaccine-controlled, efficacy was measured for the five HPV types covered only by 9vHPV vaccine (HPV31/33/45/52/58), but not the four types covered by both vaccines (HPV6/11/16/18).

Methods

Three international, randomized, double-blind studies were conducted using the same methodology. In the 9vHPV vaccine study (NCT00543543), 7106 and 7109 women received 9vHPV or qHPV vaccine, respectively. In the historic qHPV vaccine studies (FUTURE I [NCT00092521] and II [NCT00092534]), 8810 and 8812 women received qHPV vaccine or placebo, respectively, based on the same eligibility criteria. Cervical cytological testing was performed regularly. Biopsy or definitive therapy specimens were assessed for HPV DNA.

Results

Among women negative for 14 HPV types prior to vaccination, incidence of high-grade cervical disease (9vHPV, n = 2 cases; placebo, n = 141 cases) and cervical surgery (9vHPV, n = 3 cases; placebo, n = 170 cases) related to the nine HPV types was reduced by 98.2% (95% confidence interval [CI], 93.6–99.7) and 97.8% (95% CI, 93.4–99.4), respectively. The 9vHPV vaccine did not prevent disease related to vaccine HPV types detected at baseline, but significantly reduced cervical, vulvar, and vaginal diseases related to other vaccine HPV types.

Conclusions

Effective implementation of the 9vHPV vaccine may substantially reduce the burden of HPV-related diseases and related medical procedures.

Trial registrations: clinicaltrials.gov: NCT00543543, NCT00092521, NCT00092534.

Keywords

Cervical cancer
Cervical intraepithelial neoplasia (CIN)
HPV
Persistent infection
Vaccine
Vulvar intraepithelial neoplasia (VIN)

Cited by (0)

Data previously presented at the European Research Organisation on Genital Infection and Neoplasia Conference, Amsterdam, The Netherlands, 8–11 October 2017

☆☆

Gynecologic Oncology classification: Gynecologic Cancer Prevention