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Impact of human papillomavirus (HPV)-6/11/16/18 vaccine on all HPV-associated genital diseases in young women.

Publication ,  Journal Article
Muñoz, N; Kjaer, SK; Sigurdsson, K; Iversen, O-E; Hernandez-Avila, M; Wheeler, CM; Perez, G; Brown, DR; Koutsky, LA; Tay, EH; Garcia, PJ ...
Published in: J Natl Cancer Inst
March 3, 2010

BACKGROUND: The impact of the prophylactic vaccine against human papillomavirus (HPV) types 6, 11, 16, and 18 (HPV6/11/16/18) on all HPV-associated genital disease was investigated in a population that approximates sexually naive women in that they were "negative to 14 HPV types" and in a mixed population of HPV-exposed and -unexposed women (intention-to-treat group). METHODS: This analysis studied 17 622 women aged 15-26 years who were enrolled in one of two randomized, placebo-controlled, efficacy trials for the HPV6/11/16/18 vaccine (first patient on December 28, 2001, and studies completed July 31, 2007). Vaccine or placebo was given at day 1, month 2, and month 6. All women underwent cervicovaginal sampling and Papanicolaou (Pap) testing at day 1 and every 6-12 months thereafter. Outcomes were any cervical intraepithelial neoplasia; any external anogenital and vaginal lesions; Pap test abnormalities; and procedures such as colposcopy and definitive therapy. Absolute rates are expressed as women with endpoint per 100 person-years at risk. RESULTS: The average follow-up was 3.6 years (maximum of 4.9 years). In the population that was negative to 14 HPV types, vaccination was up to 100% effective in reducing the risk of HPV16/18-related high-grade cervical, vulvar, and vaginal lesions and of HPV6/11-related genital warts. In the intention-to-treat group, vaccination also statistically significantly reduced the risk of any high-grade cervical lesions (19.0% reduction; rate vaccine = 1.43, rate placebo = 1.76, difference = 0.33, 95% confidence interval [CI] = 0.13 to 0.54), vulvar and vaginal lesions (50.7% reduction; rate vaccine = 0.10, rate placebo = 0.20, difference = 0.10, 95% CI = 0.04 to 0.16), genital warts (62.0% reduction; rate vaccine = 0.44, rate placebo = 1.17, difference = 0.72, 95% CI = 0.58 to 0.87), Pap abnormalities (11.3% reduction; rate vaccine = 10.36, rate placebo = 11.68, difference = 1.32, 95% CI = 0.74 to 1.90), and cervical definitive therapy (23.0% reduction; rate vaccine = 1.97, rate placebo = 2.56, difference = 0.59, 95% CI = 0.35 to 0.83), irrespective of causal HPV type. CONCLUSIONS: High-coverage HPV vaccination programs among adolescents and young women may result in a rapid reduction of genital warts, cervical cytological abnormalities, and diagnostic and therapeutic procedures. In the longer term, substantial reductions in the rates of cervical, vulvar, and vaginal cancers may follow.

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Published In

J Natl Cancer Inst

DOI

EISSN

1460-2105

Publication Date

March 3, 2010

Volume

102

Issue

5

Start / End Page

325 / 339

Location

United States

Related Subject Headings

  • Young Adult
  • Vaginal Smears
  • Uterine Cervical Neoplasms
  • Uterine Cervical Dysplasia
  • Tumor Virus Infections
  • Sexually Transmitted Diseases
  • Sexual Partners
  • Papillomavirus Vaccines
  • Papillomavirus Infections
  • Papanicolaou Test
 

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Muñoz, N., Kjaer, S. K., Sigurdsson, K., Iversen, O.-E., Hernandez-Avila, M., Wheeler, C. M., … Haupt, R. M. (2010). Impact of human papillomavirus (HPV)-6/11/16/18 vaccine on all HPV-associated genital diseases in young women. J Natl Cancer Inst, 102(5), 325–339. https://doi.org/10.1093/jnci/djp534
Muñoz, Nubia, Susanne K. Kjaer, Kristján Sigurdsson, Ole-Erik Iversen, Mauricio Hernandez-Avila, Cosette M. Wheeler, Gonzalo Perez, et al. “Impact of human papillomavirus (HPV)-6/11/16/18 vaccine on all HPV-associated genital diseases in young women.J Natl Cancer Inst 102, no. 5 (March 3, 2010): 325–39. https://doi.org/10.1093/jnci/djp534.
Muñoz N, Kjaer SK, Sigurdsson K, Iversen O-E, Hernandez-Avila M, Wheeler CM, et al. Impact of human papillomavirus (HPV)-6/11/16/18 vaccine on all HPV-associated genital diseases in young women. J Natl Cancer Inst. 2010 Mar 3;102(5):325–39.
Muñoz, Nubia, et al. “Impact of human papillomavirus (HPV)-6/11/16/18 vaccine on all HPV-associated genital diseases in young women.J Natl Cancer Inst, vol. 102, no. 5, Mar. 2010, pp. 325–39. Pubmed, doi:10.1093/jnci/djp534.
Muñoz N, Kjaer SK, Sigurdsson K, Iversen O-E, Hernandez-Avila M, Wheeler CM, Perez G, Brown DR, Koutsky LA, Tay EH, Garcia PJ, Ault KA, Garland SM, Leodolter S, Olsson S-E, Tang GWK, Ferris DG, Paavonen J, Steben M, Bosch FX, Dillner J, Huh WK, Joura EA, Kurman RJ, Majewski S, Myers ER, Villa LL, Taddeo FJ, Roberts C, Tadesse A, Bryan JT, Lupinacci LC, Giacoletti KED, Sings HL, James MK, Hesley TM, Barr E, Haupt RM. Impact of human papillomavirus (HPV)-6/11/16/18 vaccine on all HPV-associated genital diseases in young women. J Natl Cancer Inst. 2010 Mar 3;102(5):325–339.
Journal cover image

Published In

J Natl Cancer Inst

DOI

EISSN

1460-2105

Publication Date

March 3, 2010

Volume

102

Issue

5

Start / End Page

325 / 339

Location

United States

Related Subject Headings

  • Young Adult
  • Vaginal Smears
  • Uterine Cervical Neoplasms
  • Uterine Cervical Dysplasia
  • Tumor Virus Infections
  • Sexually Transmitted Diseases
  • Sexual Partners
  • Papillomavirus Vaccines
  • Papillomavirus Infections
  • Papanicolaou Test