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The Impact of Quadrivalent Human Papillomavirus (HPV; Types 6, 11, 16, and 18) L1 Virus-Like Particle Vaccine on Infection and Disease Due to Oncogenic Nonvaccine HPV Types in Sexually Active Women Aged 16-26 Years

Wheeler, Cosette M.; Kjaer, Susanne K.; Sigurdsson, Kristjan; Iversen, Ole-Erik; Hernandez-Avila, Mauricio; Perez, Gonzalo; Brown, Darron R.; Koutsky, Laura A.; Tay, Eng Hseon and Garcia, Patricia, et al. (2009) 24th International Papillomavirus Conference and Clinical Workshop In Journal Of Infectious Diseases 199(7). p.936-944
Abstract
Background. We evaluated the impact of a quadrivalent human papillomavirus (HPV) vaccine on infection and cervical disease related to 10 nonvaccine HPV types (31, 33, 35, 39, 45, 51, 52, 56, 58, and 59) associated with >20% of cervical cancers. The population evaluated included HPV-naive women and women with preexisting HPV infection and/or HPV-related disease at enrollment. Methods. Phase 3 efficacy studies enrolled 17,622 women aged 16-26 years. Subjects underwent cervicovaginal sampling and Pap testing on day 1 and then at 6-12-month intervals for up to 4 years. HPV typing was performed on samples from enrollment and follow-up visits, including samples obtained for diagnosis or treatment of HPV-related disease. All subjects who... (More)
Background. We evaluated the impact of a quadrivalent human papillomavirus (HPV) vaccine on infection and cervical disease related to 10 nonvaccine HPV types (31, 33, 35, 39, 45, 51, 52, 56, 58, and 59) associated with >20% of cervical cancers. The population evaluated included HPV-naive women and women with preexisting HPV infection and/or HPV-related disease at enrollment. Methods. Phase 3 efficacy studies enrolled 17,622 women aged 16-26 years. Subjects underwent cervicovaginal sampling and Pap testing on day 1 and then at 6-12-month intervals for up to 4 years. HPV typing was performed on samples from enrollment and follow-up visits, including samples obtained for diagnosis or treatment of HPV-related disease. All subjects who received >= 1 dose and returned for follow-up were included. Results. Vaccination reduced the rate of HPV-31/33/45/52/58 infection by 17.7% (95% confidence interval [CI], 5.1% to 28.7%) and of cervical intraepithelial neoplasia (CIN) 1-3 or adenocarcinoma in situ (AIS) by 18.8% (95% CI, 7.4% to 28.9%). Vaccination also reduced the rate of HPV-31/58/59-related CIN1-3/AIS by 26.0% (95% CI, 6.7% to 41.4%), 28.1% (95% CI, 5.3% to 45.6%), and 37.6% (95% CI, 6.0% to 59.1%), respectively. Although a modest reduction in HPV-31/33/45/52/58-related CIN2 or worse was observed, the estimated reduction was not statistically significant. Conclusions. These cross-protection results complement the vaccine's prophylactic efficacy against disease associated with HPV-6, -11, -16, and - 18. Long-term monitoring of vaccinated populations are needed to fully ascertain the population-based impact and public health significance of these findings. (Less)
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publication status
published
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in
Journal Of Infectious Diseases
volume
199
issue
7
pages
936 - 944
publisher
University of Chicago Press
conference name
24th International Papillomavirus Conference and Clinical Workshop
external identifiers
  • wos:000264056600004
  • scopus:65549116473
ISSN
0022-1899
DOI
10.1086/597309
language
English
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yes
id
0eba5f86-2ab0-430d-823f-618d499e7b85 (old id 1404742)
date added to LUP
2009-06-15 09:45:38
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2017-11-19 04:02:03
@inproceedings{0eba5f86-2ab0-430d-823f-618d499e7b85,
  abstract     = {Background. We evaluated the impact of a quadrivalent human papillomavirus (HPV) vaccine on infection and cervical disease related to 10 nonvaccine HPV types (31, 33, 35, 39, 45, 51, 52, 56, 58, and 59) associated with >20% of cervical cancers. The population evaluated included HPV-naive women and women with preexisting HPV infection and/or HPV-related disease at enrollment. Methods. Phase 3 efficacy studies enrolled 17,622 women aged 16-26 years. Subjects underwent cervicovaginal sampling and Pap testing on day 1 and then at 6-12-month intervals for up to 4 years. HPV typing was performed on samples from enrollment and follow-up visits, including samples obtained for diagnosis or treatment of HPV-related disease. All subjects who received >= 1 dose and returned for follow-up were included. Results. Vaccination reduced the rate of HPV-31/33/45/52/58 infection by 17.7% (95% confidence interval [CI], 5.1% to 28.7%) and of cervical intraepithelial neoplasia (CIN) 1-3 or adenocarcinoma in situ (AIS) by 18.8% (95% CI, 7.4% to 28.9%). Vaccination also reduced the rate of HPV-31/58/59-related CIN1-3/AIS by 26.0% (95% CI, 6.7% to 41.4%), 28.1% (95% CI, 5.3% to 45.6%), and 37.6% (95% CI, 6.0% to 59.1%), respectively. Although a modest reduction in HPV-31/33/45/52/58-related CIN2 or worse was observed, the estimated reduction was not statistically significant. Conclusions. These cross-protection results complement the vaccine's prophylactic efficacy against disease associated with HPV-6, -11, -16, and - 18. Long-term monitoring of vaccinated populations are needed to fully ascertain the population-based impact and public health significance of these findings.},
  author       = {Wheeler, Cosette M. and Kjaer, Susanne K. and Sigurdsson, Kristjan and Iversen, Ole-Erik and Hernandez-Avila, Mauricio and Perez, Gonzalo and Brown, Darron R. and Koutsky, Laura A. and Tay, Eng Hseon and Garcia, Patricia and Ault, Kevin A. and Garland, Suzanne M. and Leodolter, Sepp and Olsson, Sven-Eric and Tang, Grace W. K. and Ferris, Daron G. and Paavonen, Jorma and Steben, Marc and Bosch, F. Xavier and Dillner, Joakim and Joura, Elmar A. and Kurman, Robert J. and Majewski, Slawomir and Munoz, Nubia and Myers, Evan R. and Villa, Luisa L. and Taddeo, Frank J. and Roberts, Christine and Tadesse, Amha and Bryan, Janine and Lupinacci, Lisa C. and Giacoletti, Katherine E. D. and James, Margaret and Vuocolo, Scott and Hesley, Teresa M. and Barr, Eliav},
  booktitle    = {Journal Of Infectious Diseases},
  issn         = {0022-1899},
  language     = {eng},
  number       = {7},
  pages        = {936--944},
  publisher    = {University of Chicago Press},
  title        = {The Impact of Quadrivalent Human Papillomavirus (HPV; Types 6, 11, 16, and 18) L1 Virus-Like Particle Vaccine on Infection and Disease Due to Oncogenic Nonvaccine HPV Types in Sexually Active Women Aged 16-26 Years},
  url          = {http://dx.doi.org/10.1086/597309},
  volume       = {199},
  year         = {2009},
}