Long-term follow-up observation of the safety, immunogenicity, and effectiveness of Gardasil™ in adult women

PLoS One. 2013 Dec 31;8(12):e83431. doi: 10.1371/journal.pone.0083431. eCollection 2013.

Abstract

Background: Previous analyses from a randomized trial in women aged 24-45 have shown the quadrivalent HPV vaccine to be efficacious in the prevention of infection, cervical intraepithelial neoplasia (CIN) and external genital lesions (EGL) related to HPV 6/11/16/18 through 4 years. In this report we present long term follow-up data on the efficacy, safety and immunogenicity of the quadrivalent HPV vaccine in adult women.

Methods: Follow-up data are from a study being conducted in 5 sites in Colombia designed to evaluate the long-term immunogenicity, effectiveness, and safety of the qHPV vaccine in women who were vaccinated at 24 to 45 years of age (in the original vaccine group during the base study [n = 684]) or 29 to 50 years of age (in the original placebo group during the base study [n = 651]). This analysis summarizes data collected as of the year 6 post-vaccination visit relative to day 1 of the base study (median follow-up of 6.26 years) from both the original base study and the Colombian follow-up.

Results: There were no cases of HPV 6/11/16/18-related CIN or EGL during the extended follow-up phase in the per-protocol population. Immunogenicity persists against vaccine-related HPV types, and no evidence of HPV type replacement has been observed. No new serious adverse experiences have been reported.

Conclusions: Vaccination with qHPV vaccine provides generally safe and effective protection from HPV 6-, 11-, 16-, and 18-related genital warts and cervical dysplasia through 6 years following administration to 24-45 year-old women.

Trial registration: Clinicaltrials.govNCT00090220.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Colombia
  • Condylomata Acuminata / prevention & control
  • Double-Blind Method
  • Female
  • Follow-Up Studies
  • Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18
  • Human papillomavirus 11 / immunology
  • Human papillomavirus 16 / immunology
  • Human papillomavirus 18 / immunology
  • Human papillomavirus 6 / immunology
  • Humans
  • Middle Aged
  • Papillomavirus Infections / prevention & control
  • Papillomavirus Vaccines / adverse effects
  • Papillomavirus Vaccines / immunology
  • Papillomavirus Vaccines / therapeutic use*
  • Pregnancy
  • Safety
  • Treatment Outcome
  • Uterine Cervical Dysplasia / prevention & control
  • Uterine Cervical Neoplasms / prevention & control
  • Young Adult

Substances

  • Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18
  • Papillomavirus Vaccines

Associated data

  • ClinicalTrials.gov/NCT00090220