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

Cosette M. Wheeler, Susanne K. Kjaer, Kristján Sigurdsson, Ole Erik Iversen, Hernandez Avila Mauricio, Gonzalo Perez, Darron Brown, Laura A. Koutsky, Eng Hseon Tay, Patricia García, Kevin A. Ault, Suzanne M. Garland, Sepp Leodolter, Sven Eric Olsson, Grace W K Tang, Daron G. Ferris, Jorma Paavonen, Marc Steben, F. Xavier Bosch, Joakim DillnerElmar A. Joura, Robert J. Kurman, Slawomir Majewski, Nubia Muñoz, Evan R. Myers, Luisa L. Villa, Frank J. Taddeo, Christine Roberts, Amha Tadesse, Janine Bryan, Lisa C. Lupinacci, Katherine E D Giacoletti, Margaret James, Scott Vuocolo, Teresa M. Hesley, Eliav Barra

Research output: Contribution to journalArticle

202 Citations (Scopus)

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. Trial registration. ClinicalTrials.gov identifiers: NCT00092521, NCT00092534, and NCT00092482.

Original languageEnglish
Pages (from-to)936-944
Number of pages9
JournalJournal of Infectious Diseases
Volume199
Issue number7
DOIs
StatePublished - Apr 1 2009

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Virus-Like Particle Vaccines
Human papillomavirus 6
Human papillomavirus 31
Confidence Intervals
Infection
Vaccination
Cross Protection
Population
Human papillomavirus 11
Papillomavirus Vaccines
Cervical Intraepithelial Neoplasia
Papillomavirus Infections
Uterine Cervical Neoplasms
Vaccines
Public Health

ASJC Scopus subject areas

  • Infectious Diseases
  • Immunology and Allergy

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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, Kristján; Iversen, Ole Erik; Mauricio, Hernandez Avila; Perez, Gonzalo; Brown, Darron; Koutsky, Laura A.; Tay, Eng Hseon; García, Patricia; Ault, Kevin A.; Garland, Suzanne M.; Leodolter, Sepp; Olsson, Sven Eric; Tang, Grace W K; Ferris, Daron G.; Paavonen, Jorma; Steben, Marc; Bosch, F. Xavier; Dillner, Joakim; Joura, Elmar A.; Kurman, Robert J.; Majewski, Slawomir; Muñoz, Nubia; Myers, Evan R.; Villa, Luisa L.; Taddeo, Frank J.; Roberts, Christine; Tadesse, Amha; Bryan, Janine; Lupinacci, Lisa C.; Giacoletti, Katherine E D; James, Margaret; Vuocolo, Scott; Hesley, Teresa M.; Barra, Eliav.

In: Journal of Infectious Diseases, Vol. 199, No. 7, 01.04.2009, p. 936-944.

Research output: Contribution to journalArticle

Wheeler, CM, Kjaer, SK, Sigurdsson, K, Iversen, OE, Mauricio, HA, Perez, G, Brown, D, Koutsky, LA, Tay, EH, García, P, Ault, KA, Garland, SM, Leodolter, S, Olsson, SE, Tang, GWK, Ferris, DG, Paavonen, J, Steben, M, Bosch, FX, Dillner, J, Joura, EA, Kurman, RJ, Majewski, S, Muñoz, N, Myers, ER, Villa, LL, Taddeo, FJ, Roberts, C, Tadesse, A, Bryan, J, Lupinacci, LC, Giacoletti, KED, James, M, Vuocolo, S, Hesley, TM & Barra, E 2009, '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', Journal of Infectious Diseases, vol. 199, no. 7, pp. 936-944. https://doi.org/10.1086/597309
Wheeler, Cosette M. ; Kjaer, Susanne K. ; Sigurdsson, Kristján ; Iversen, Ole Erik ; Mauricio, Hernandez Avila ; Perez, Gonzalo ; Brown, Darron ; Koutsky, Laura A. ; Tay, Eng Hseon ; García, Patricia ; Ault, Kevin A. ; Garland, Suzanne M. ; Leodolter, Sepp ; Olsson, Sven Eric ; Tang, Grace W K ; Ferris, Daron G. ; Paavonen, Jorma ; Steben, Marc ; Bosch, F. Xavier ; Dillner, Joakim ; Joura, Elmar A. ; Kurman, Robert J. ; Majewski, Slawomir ; Muñoz, Nubia ; Myers, Evan R. ; Villa, Luisa L. ; Taddeo, Frank J. ; Roberts, Christine ; Tadesse, Amha ; Bryan, Janine ; Lupinacci, Lisa C. ; Giacoletti, Katherine E D ; James, Margaret ; Vuocolo, Scott ; Hesley, Teresa M. ; Barra, Eliav. / 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. In: Journal of Infectious Diseases. 2009 ; Vol. 199, No. 7. pp. 936-944.
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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",
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. Trial registration. ClinicalTrials.gov identifiers: NCT00092521, NCT00092534, and NCT00092482.",
author = "Wheeler, {Cosette M.} and Kjaer, {Susanne K.} and Kristj{\'a}n Sigurdsson and Iversen, {Ole Erik} and Mauricio, {Hernandez Avila} and Gonzalo Perez and Darron Brown and Koutsky, {Laura A.} and Tay, {Eng Hseon} and Patricia Garc{\'i}a and Ault, {Kevin A.} and Garland, {Suzanne M.} and Sepp Leodolter and Olsson, {Sven Eric} and Tang, {Grace W K} and Ferris, {Daron G.} and Jorma Paavonen and Marc Steben and Bosch, {F. Xavier} and Joakim Dillner and Joura, {Elmar A.} and Kurman, {Robert J.} and Slawomir Majewski and Nubia Mu{\~n}oz and Myers, {Evan R.} and Villa, {Luisa L.} and Taddeo, {Frank J.} and Christine Roberts and Amha Tadesse and Janine Bryan and Lupinacci, {Lisa C.} and Giacoletti, {Katherine E D} and Margaret James and Scott Vuocolo and Hesley, {Teresa M.} and Eliav Barra",
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TY - JOUR

T1 - 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

AU - Wheeler, Cosette M.

AU - Kjaer, Susanne K.

AU - Sigurdsson, Kristján

AU - Iversen, Ole Erik

AU - Mauricio, Hernandez Avila

AU - Perez, Gonzalo

AU - Brown, Darron

AU - Koutsky, Laura A.

AU - Tay, Eng Hseon

AU - García, Patricia

AU - Ault, Kevin A.

AU - Garland, Suzanne M.

AU - Leodolter, Sepp

AU - Olsson, Sven Eric

AU - Tang, Grace W K

AU - Ferris, Daron G.

AU - Paavonen, Jorma

AU - Steben, Marc

AU - Bosch, F. Xavier

AU - Dillner, Joakim

AU - Joura, Elmar A.

AU - Kurman, Robert J.

AU - Majewski, Slawomir

AU - Muñoz, Nubia

AU - Myers, Evan R.

AU - Villa, Luisa L.

AU - Taddeo, Frank J.

AU - Roberts, Christine

AU - Tadesse, Amha

AU - Bryan, Janine

AU - Lupinacci, Lisa C.

AU - Giacoletti, Katherine E D

AU - James, Margaret

AU - Vuocolo, Scott

AU - Hesley, Teresa M.

AU - Barra, Eliav

PY - 2009/4/1

Y1 - 2009/4/1

N2 - 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.

AB - 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.

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