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
BackgroundWe 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...
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| Published in | The Journal of infectious diseases Vol. 199; no. 7; pp. 936 - 944 |
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| Main Authors | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
| Format | Journal Article Conference Proceeding |
| Language | English |
| Published |
Oxford
The University of Chicago Press
01.04.2009
University of Chicago Press Oxford University Press |
| Subjects | |
| Online Access | Get full text |
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| Abstract | BackgroundWe 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 MethodsPhase 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 ResultsVaccination 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 ConclusionsThese 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 Trial registrationClinicalTrials.gov identifiers: NCT00092521, NCT00092534, and NCT00092482 |
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| AbstractList | 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.BACKGROUNDWe 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.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.METHODSPhase 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.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.RESULTSVaccination 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.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.CONCLUSIONSThese 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.ClinicalTrials.gov identifiers: NCT00092521 , NCT00092534 , and NCT00092482.TRIAL REGISTRATIONClinicalTrials.gov identifiers: NCT00092521 , NCT00092534 , and NCT00092482. 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. 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. 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. 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. ClinicalTrials.gov identifiers: NCT00092521 , NCT00092534 , and NCT00092482. 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. Trial registration. ClinicalTrials.gov identifiers: NCT00092521,NCT00092534,and NCT00092482. 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 [image]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. Trial registration. ClinicalTrials.gov identifiers: BackgroundWe 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 MethodsPhase 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 ResultsVaccination 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 ConclusionsThese 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 Trial registrationClinicalTrials.gov identifiers: NCT00092521, NCT00092534, and NCT00092482 BackgroundWe 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 MethodsPhase 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 ResultsVaccination 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 ConclusionsThese 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 Trial registrationClinicalTrials.gov identifiers: NCT00092521, NCT00092534, and NCT00092482 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 | Leodolter, Sepp Steben, Marc Dillner, Joakim Hernandez-Avila, Mauricio Villa, Luisa L. Olsson, Sven-Eric Iversen, Ole-Erik Sigurdsson, Kristján Garland, Suzanne M. Myers, Evan R. Bosch, F. Xavier Majewski, Slawomir Perez, Gonzalo Kjaer, Susanne K. Taddeo, Frank J. García, Patricia Brown, Darron R. Ault, Kevin A. Muñoz, Nubia Roberts, Christine Ferris, Daron G. Koutsky, Laura A. Tay, Eng Hseon Joura, Elmar A. Vuocolo, Scott Paavonen, Jorma Bryan, Janine Barr, Eliav Kurman, Robert J. Giacoletti, Katherine E. D. Hesley, Teresa M. Tang, Grace W. K. James, Margaret Wheeler, Cosette M. Tadesse, Amha Lupinacci, Lisa C. |
| Author_xml | – sequence: 1 givenname: Cosette M. surname: Wheeler fullname: Wheeler, Cosette M. email: cwheeler@salud.unm.edu organization: E-mail: cwheeler@salud.unm.edu – sequence: 2 givenname: Susanne K. surname: Kjaer fullname: Kjaer, Susanne K. – sequence: 3 givenname: Kristján surname: Sigurdsson fullname: Sigurdsson, Kristján – sequence: 4 givenname: Ole-Erik surname: Iversen fullname: Iversen, Ole-Erik – sequence: 5 givenname: Mauricio surname: Hernandez-Avila fullname: Hernandez-Avila, Mauricio – sequence: 6 givenname: Gonzalo surname: Perez fullname: Perez, Gonzalo – sequence: 7 givenname: Darron R. surname: Brown fullname: Brown, Darron R. – sequence: 8 givenname: Laura A. surname: Koutsky fullname: Koutsky, Laura A. – sequence: 9 givenname: Eng Hseon surname: Tay fullname: Tay, Eng Hseon – sequence: 10 givenname: Patricia surname: García fullname: García, Patricia – sequence: 11 givenname: Kevin A. surname: Ault fullname: Ault, Kevin A. – sequence: 12 givenname: Suzanne M. surname: Garland fullname: Garland, Suzanne M. – sequence: 13 givenname: Sepp surname: Leodolter fullname: Leodolter, Sepp – sequence: 14 givenname: Sven-Eric surname: Olsson fullname: Olsson, Sven-Eric – sequence: 15 givenname: Grace W. K. surname: Tang fullname: Tang, Grace W. K. – sequence: 16 givenname: Daron G. surname: Ferris fullname: Ferris, Daron G. – sequence: 17 givenname: Jorma surname: Paavonen fullname: Paavonen, Jorma – sequence: 18 givenname: Marc surname: Steben fullname: Steben, Marc – sequence: 19 givenname: F. Xavier surname: Bosch fullname: Bosch, F. Xavier – sequence: 20 givenname: Joakim surname: Dillner fullname: Dillner, Joakim – sequence: 21 givenname: Elmar A. surname: Joura fullname: Joura, Elmar A. – sequence: 22 givenname: Robert J. surname: Kurman fullname: Kurman, Robert J. – sequence: 23 givenname: Slawomir surname: Majewski fullname: Majewski, Slawomir – sequence: 24 givenname: Nubia surname: Muñoz fullname: Muñoz, Nubia – sequence: 25 givenname: Evan R. surname: Myers fullname: Myers, Evan R. – sequence: 26 givenname: Luisa L. surname: Villa fullname: Villa, Luisa L. – sequence: 27 givenname: Frank J. surname: Taddeo fullname: Taddeo, Frank J. – sequence: 28 givenname: Christine surname: Roberts fullname: Roberts, Christine – sequence: 29 givenname: Amha surname: Tadesse fullname: Tadesse, Amha – sequence: 30 givenname: Janine surname: Bryan fullname: Bryan, Janine – sequence: 31 givenname: Lisa C. surname: Lupinacci fullname: Lupinacci, Lisa C. – sequence: 32 givenname: Katherine E. D. surname: Giacoletti fullname: Giacoletti, Katherine E. D. – sequence: 33 givenname: Margaret surname: James fullname: James, Margaret – sequence: 34 givenname: Scott surname: Vuocolo fullname: Vuocolo, Scott – sequence: 35 givenname: Teresa M. surname: Hesley fullname: Hesley, Teresa M. – sequence: 36 givenname: Eliav surname: Barr fullname: Barr, Eliav |
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| Keywords | Papillomavirus Virus Human Infection Human papillomavirus Microbiology Virus like particle Female Vaccine Papovaviridae |
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| PublicationTitle | The Journal of infectious diseases |
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| Snippet | BackgroundWe evaluated the impact of a quadrivalent human papillomavirus (HPV) vaccine on infection and cervical disease related to 10 nonvaccine HPV types... Background. We evaluated the impact of a quadrivalent human papillomavirus (HPV) vaccine on infection and cervical disease related to 10 nonvaccine HPV types... 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,... |
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| SubjectTerms | Adenocarcinoma Adenocarcinoma - prevention & control Adenocarcinoma - virology Adolescent Adult Alphapapillomavirus - classification Alphapapillomavirus - genetics Alphapapillomavirus - immunology Applied microbiology Biological and medical sciences Cervical cancer Cervical intraepithelial neoplasia Cervical Intraepithelial Neoplasia - prevention & control Cervical Intraepithelial Neoplasia - virology Clinical Medicine Epidemiology Fees Female Fundamental and applied biological sciences. Psychology Human papillomavirus Humans Infections Infectious diseases Infectious Medicine Infektionsmedicin Klinisk medicin Lesions Medical and Health Sciences Medical sciences Medicin och hälsovetenskap Microbiology Miscellaneous Papillomavirus Infections - prevention & control Papillomavirus Infections - virology Papillomavirus Vaccines Placebos Uterine Cervical Neoplasms - prevention & control Uterine Cervical Neoplasms - virology Vaccination Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects) Virology Viruses Young Adult |
| 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 |
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