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

Villa, Luisa L.; Perez, Gonzalo; Kjaer, Susanne K.; Paavonen, Jorma; Lehtinen, Matti; Munoz, Nubia; Sigurdsson, Kristjan; Hernandez-Avila, Mauricio; Skjeldestad, Finn Egil and Thoresen, Steinar, et al. (2007) In New England Journal of Medicine 356(19). p.1915-1927
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... (More)
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. (Less)
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published
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New England Journal of Medicine
volume
356
issue
19
pages
1915 - 1927
publisher
Massachusetts Medical Society
external identifiers
  • wos:000246305500004
  • scopus:34248326338
ISSN
0028-4793
DOI
10.1056/NEJMoa061741
language
English
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yes
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f908378b-b855-4501-b82d-2d917663712c (old id 667293)
date added to LUP
2007-12-19 13:13:09
date last changed
2017-11-19 03:29:21
@article{f908378b-b855-4501-b82d-2d917663712c,
  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.},
  author       = {Villa, Luisa L. and Perez, Gonzalo and Kjaer, Susanne K. and Paavonen, Jorma and Lehtinen, Matti and Munoz, Nubia and Sigurdsson, Kristjan and Hernandez-Avila, Mauricio and Skjeldestad, Finn Egil and Thoresen, Steinar and Garcia, Patricia and Majewski, Slawomir and Dillner, Joakim and Olsson, Sven-Eric and Tay, Eng Hseon and Bosch, F. Xavier and Ault, Kevin A. and Brown, Darron R. and Ferris, Daron G. and Koutsky, Laura A. and Kurman, Robert J. and Myers, Evan R. and Barr, Eliav and Boslego, John and Bryan, Janine and Esser, Mark T. and Gause, Christine K. and Hesley, Teresa M. and Lupinacci, Lisa C. and Sings, Heather L. and Taddeo, Frank J. and Thornton, Annemarie R. and Boulos, M. and Cox, J. T. and Langmark, F. and Modlin, J. and Munoz, A. and Odlind, V. and Wilkinson, E. and Ferenczy, A. and Kurman, R. and Ronett, B. and Stoler, M. and Andreoni, G. and Bahamondes, L. and Camargos, A. and Costa, R. and De Andrade, R. and Fedrizzi, E. and Ferriani, R. and Goncalves, M. and Laginha, F. and Mendonca, J. and Moreira, E., Jr. and Nonnenmacher, B. and Taborda, W. and Zanetta, D. and Ardila, J. and Balcazar, N. and Maldonado, I. and Revollo, F. and Ruiz, A. and Andersen, E. S. and Djursing, H. and Hansen, T. and Jorgensen, J. J. and Nilas, L. and Ottesen, B. and Petersen, L. K. and Thomsen, S. G. and Toftager-Larsen, K. and Apter, D. and Kekki, M. and Kuortti, M. and Lahti, L. and Lindroos, Y. and Lunnas, T. and Paavonen, J. and Palmroth, J. and Sigurdsson, K. and Lazcano, E. and Zertuche, J. and Dalaker, K. and Eriksen, B. and Erno, L. E. and Fiane, B. and Hesla, K. and Isachsen, M. Myhre and Iversen, O. E. and Kasin, K. and Kristoffersen, M. and Lunde, T. and Nordmark, P. T. and Nygaard, T. and Onsrud, M. and Riis-Johannessen, G. and Schiotz, H. and Skjeldestad, F. E. and Sundhagen, H. and Sviggum, O. and Trosterud, K. A. and Garcia, P. and Penny, M. and Vivar, A. and Basta, A. and Czajkowski, K. and Knapp, P. and Spaczynski, M. and Barnes, R. and Tay, E. H. and Elfgren, K. and Hardmeier, E. and Hellsten, C. and Hofte, C. and Jensen, P. and Johannisson, G. and Loewhagen, G. -B. and Olsson, S. -E. and Steinwall, M. and Tamsen, L. and Varnauskas, T. and Wikstroem, A. and Crawford, G. and Allen, B. and Ault, K. and Brown, D. and Edwards, R. and Comerci, J. and Giuliano, A. and Greer, S. and Hatch, K. and Kriesel, J. and Lalezari, J. and Partridge, E. and Sperling, R. and Spruance, S. and Stapleton, J. and Wright, P. and Zedler, P. and McCarroll, K. and Zhang, L. and Zhou, H.},
  issn         = {0028-4793},
  language     = {eng},
  number       = {19},
  pages        = {1915--1927},
  publisher    = {Massachusetts Medical Society},
  series       = {New England Journal of Medicine},
  title        = {Quadrivalent vaccine against human papillomavirus to prevent high-grade cervical lesions},
  url          = {http://dx.doi.org/10.1056/NEJMoa061741},
  volume       = {356},
  year         = {2007},
}