Quadrivalent vaccine against human papillomavirus to prevent high-grade cervical lesions

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Abstract

BACKGROUND: Human papillomavirus types 16 (HPV-16) and 18 (HPV-18) cause approximately 70% of cervical cancers worldwide. A phase 3 trial was conducted to evaluate a quadrivalent vaccine against HPV types 6, 11, 16, and 18 (HPV-6/11/16/18) for the prevention of high-grade cervical lesions associated with HPV-16 and HPV-18. METHODS: In this randomized, double-blind trial, we assigned 12,167 women between the ages of 15 and 26 years to receive three doses of either HPV-6/11/16/18 vaccine or placebo, administered at day 1, month 2, and month 6. The primary analysis was performed for a per-protocol susceptible population that included 5305 women in the vaccine group and 5260 in the placebo group who had no virologic evidence of infection with HPV-16 or HPV-18 through 1 month after the third dose (month 7). The primary composite end point was cervical intraepithelial neoplasia grade 2 or 3, adenocarcinoma in situ, or cervical cancer related to HPV-16 or HPV-18. RESULTS: Subjects were followed for an average of 3 years after receiving the first dose of vaccine or placebo. Vaccine efficacy for the prevention of the primary composite end point was 98% (95.89% confidence interval [CI], 86 to 100) in the per-protocol susceptible population and 44% (95% CI, 26 to 58) in an intention-to-treat population of all women who had undergone randomization (those with or without previous infection). The estimated vaccine efficacy against all high-grade cervical lesions, regardless of causal HPV type, in this intention-to-treat population was 17% (95% CI, 1 to 31). CONCLUSIONS: In young women who had not been previously infected with HPV-16 or HPV-18, those in the vaccine group had a significantly lower occurrence of high-grade cervical intraepithelial neoplasia related to HPV-16 or HPV-18 than did those in the placebo group. (ClinicalTrials.gov number, NCT00092534 [ClinicalTrials.gov].)

Author-supplied keywords

  • 26
  • 86
  • ALL
  • Adolescent
  • Adverse Effects
  • Alphapapillomavirus
  • Analysis
  • Article
  • CANCERS
  • CERVICAL-CANCER
  • CONTROLLED TRIAL
  • DNA
  • DNA,Viral
  • DOUBLE-BLIND
  • Double-Blind Method
  • EFFICACY
  • Follow-Up Studies
  • GRADE
  • HIGH-GRADE
  • HPV
  • HPV 16
  • HPV 16 and HPv 18
  • HPV 18
  • HPV TYPES
  • HPV-16
  • HPV-18
  • HPV16
  • HPV18
  • HUMAN PAPILLOMAVIRUS TYPE
  • HUMAN PAPILLOMAVIRUS TYPES
  • HUMAN-PAPILLOMAVIRUS
  • HUMANS
  • Human papillomavirus 18
  • IN-SITU
  • INTRAEPITHELIAL NEOPLASIA
  • Isolation & Purification
  • L1
  • LESIONS
  • MULTICENTER
  • Multicenter Studies
  • NO
  • NUMBER
  • PAPILLOMAVIRUS INFECTIONS
  • PAPILLOMAVIRUS TYPES
  • PHASE
  • PLACEBO
  • PREVENTION
  • Papillomavirus Vaccines
  • Population
  • Prevention & Control
  • RANDOMIZED CONTROLLED TRIAL
  • TRIAL
  • Uterine Cervical Neoplasms
  • WORLDWIDE
  • YOUNG
  • YOUNG-WOMEN
  • adenocarcinoma
  • adult
  • age
  • blood
  • cancer
  • cervical
  • cervical cancer
  • cervical cancers
  • cervical intraepithelial neoplasia
  • cervical lesion
  • cervical lesions
  • conclusion
  • epidemiology
  • female
  • genetics
  • human
  • human papillomavirus
  • human papillomavirus 16
  • in situ
  • infection
  • lesion
  • method
  • methods
  • neoplasia
  • papillomavirus
  • point
  • research
  • time factors
  • treatment outcome
  • vaccine
  • vaccines
  • viral
  • women

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  • The FUTURE I I Study Group

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