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

Publication ,  Journal Article
FUTURE II Study Group,
Published in: N Engl J Med
May 10, 2007

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].).

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Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

May 10, 2007

Volume

356

Issue

19

Start / End Page

1915 / 1927

Location

United States

Related Subject Headings

  • Uterine Cervical Neoplasms
  • Uterine Cervical Dysplasia
  • Treatment Outcome
  • Time Factors
  • Papillomavirus Vaccines
  • Papillomavirus Infections
  • Humans
  • Human papillomavirus 18
  • Human papillomavirus 16
  • Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18
 

Citation

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FUTURE II Study Group, . (2007). Quadrivalent vaccine against human papillomavirus to prevent high-grade cervical lesions. N Engl J Med, 356(19), 1915–1927. https://doi.org/10.1056/NEJMoa061741
FUTURE II Study Group, A Brad. “Quadrivalent vaccine against human papillomavirus to prevent high-grade cervical lesions.N Engl J Med 356, no. 19 (May 10, 2007): 1915–27. https://doi.org/10.1056/NEJMoa061741.
FUTURE II Study Group. Quadrivalent vaccine against human papillomavirus to prevent high-grade cervical lesions. N Engl J Med. 2007 May 10;356(19):1915–27.
FUTURE II Study Group, A. Brad. “Quadrivalent vaccine against human papillomavirus to prevent high-grade cervical lesions.N Engl J Med, vol. 356, no. 19, May 2007, pp. 1915–27. Pubmed, doi:10.1056/NEJMoa061741.
FUTURE II Study Group. Quadrivalent vaccine against human papillomavirus to prevent high-grade cervical lesions. N Engl J Med. 2007 May 10;356(19):1915–1927.

Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

May 10, 2007

Volume

356

Issue

19

Start / End Page

1915 / 1927

Location

United States

Related Subject Headings

  • Uterine Cervical Neoplasms
  • Uterine Cervical Dysplasia
  • Treatment Outcome
  • Time Factors
  • Papillomavirus Vaccines
  • Papillomavirus Infections
  • Humans
  • Human papillomavirus 18
  • Human papillomavirus 16
  • Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18