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 generally HPV-naive women aged 16-26 years

Darron Brown, Susanne K. Kjaer, Kristján Sigurdsson, Ole Erik Iversen, Hernandez Avila Mauricio, Cosette M. Wheeler, Gonzalo Perez, Laura A. Koutsky, Eng Hseon Tay, Patricía Garcia, 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 Dillner & 16 others Elmar 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, Heather L. Sings, Margaret James, Teresa M. Hesley, Eliav Barra

Research output: Contribution to journalArticle

420 Citations (Scopus)

Abstract

Background. Human papillomavirus (HPV)-6/11/16/18 vaccine reduces the risk of HPV-6/11/16/18-related cervical intraepithelial neoplasia (CIN) 1-3 or adenocarcinoma in situ (AIS). Here, its impact on CIN1-3/AIS associated with nonvaccine oncogenic HPV types was evaluated. Methods. We enrolled 17,622 women aged 16-26 years. All underwent cervicovaginal sampling and Pap testing at regular intervals for up to 4 years. HPV genotying was performed for biopsy samples, and histological diagnoses were determined by a pathology panel. Analyses were conducted among subjects who were negative for 14 HPV types on day 1. Prespecified analyses included infection of-6 months' duration and CIN1-3/AIS due to the 2 and 5 most common HPV types in cervical cancer after HPV types 16 and 18, as well as all tested nonvaccine types. Results. Vaccination reduced the incidence of HPV-31/45 infection by 40.3% (95% confidence interval [CI], 13.9% to 59.0%) and of CIN1-3/AIS by 43.6% (95% CI, 12.9% to 64.1%), respectively. The reduction in HPV-31/ 33/45/52/58 infection and CIN1-3/AIS was 25.0% (95% CI, 5.0% to 40.9%) and 29.2% (95% CI, 8.3% to 45.5%), respectively. Efficacy for CIN2-3/AIS associated with the 10 nonvaccine HPV types was 32.5% (95% CI, 6.0% to 51.9%). Reductions were most notable for HPV-31. Conclusions. HPV-6/11/16/18 vaccine reduced the risk of CIN2-3/AIS associated with nonvaccine types responsible for 20% of cervical cancers. The clinical benefit of cross-protection is not expected to be fully additive to the efficacy already observed against HPV-6/11/16/18-related disease, because women may have >1 CIN lesion, each associated with a different HPV type. Trial registration. ClinicalTrials.gov identifiers: NCT00092521, NCT00092534, and NCT00092482.

Original languageEnglish
Pages (from-to)926-935
Number of pages10
JournalJournal of Infectious Diseases
Volume199
Issue number7
DOIs
StatePublished - Apr 1 2009

Fingerprint

Virus-Like Particle Vaccines
Human papillomavirus 6
Human papillomavirus 11
Human papillomavirus 31
Infection
Confidence Intervals
Cervical Intraepithelial Neoplasia
Uterine Cervical Neoplasms
Vaccines
Cross Protection
Human papillomavirus 18
Human papillomavirus 16
Adenocarcinoma in Situ
Vaccination
Pathology
Biopsy
Incidence

ASJC Scopus subject areas

  • Infectious Diseases
  • Immunology and Allergy

Cite this

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 generally HPV-naive women aged 16-26 years. / Brown, Darron; Kjaer, Susanne K.; Sigurdsson, Kristján; Iversen, Ole Erik; Mauricio, Hernandez Avila; Wheeler, Cosette M.; Perez, Gonzalo; Koutsky, Laura A.; Tay, Eng Hseon; Garcia, Patricía; 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; Sings, Heather L.; James, Margaret; Hesley, Teresa M.; Barra, Eliav.

In: Journal of Infectious Diseases, Vol. 199, No. 7, 01.04.2009, p. 926-935.

Research output: Contribution to journalArticle

Brown, D, Kjaer, SK, Sigurdsson, K, Iversen, OE, Mauricio, HA, Wheeler, CM, Perez, G, Koutsky, LA, Tay, EH, Garcia, 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, Sings, HL, James, M, 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 generally HPV-naive women aged 16-26 years', Journal of Infectious Diseases, vol. 199, no. 7, pp. 926-935. https://doi.org/10.1086/597307
Brown, Darron ; Kjaer, Susanne K. ; Sigurdsson, Kristján ; Iversen, Ole Erik ; Mauricio, Hernandez Avila ; Wheeler, Cosette M. ; Perez, Gonzalo ; Koutsky, Laura A. ; Tay, Eng Hseon ; Garcia, Patricía ; 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 ; Sings, Heather L. ; James, Margaret ; 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 generally HPV-naive women aged 16-26 years. In: Journal of Infectious Diseases. 2009 ; Vol. 199, No. 7. pp. 926-935.
@article{2f931cd81011496d80e74988d9fe5188,
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 generally HPV-naive women aged 16-26 years",
abstract = "Background. Human papillomavirus (HPV)-6/11/16/18 vaccine reduces the risk of HPV-6/11/16/18-related cervical intraepithelial neoplasia (CIN) 1-3 or adenocarcinoma in situ (AIS). Here, its impact on CIN1-3/AIS associated with nonvaccine oncogenic HPV types was evaluated. Methods. We enrolled 17,622 women aged 16-26 years. All underwent cervicovaginal sampling and Pap testing at regular intervals for up to 4 years. HPV genotying was performed for biopsy samples, and histological diagnoses were determined by a pathology panel. Analyses were conducted among subjects who were negative for 14 HPV types on day 1. Prespecified analyses included infection of-6 months' duration and CIN1-3/AIS due to the 2 and 5 most common HPV types in cervical cancer after HPV types 16 and 18, as well as all tested nonvaccine types. Results. Vaccination reduced the incidence of HPV-31/45 infection by 40.3{\%} (95{\%} confidence interval [CI], 13.9{\%} to 59.0{\%}) and of CIN1-3/AIS by 43.6{\%} (95{\%} CI, 12.9{\%} to 64.1{\%}), respectively. The reduction in HPV-31/ 33/45/52/58 infection and CIN1-3/AIS was 25.0{\%} (95{\%} CI, 5.0{\%} to 40.9{\%}) and 29.2{\%} (95{\%} CI, 8.3{\%} to 45.5{\%}), respectively. Efficacy for CIN2-3/AIS associated with the 10 nonvaccine HPV types was 32.5{\%} (95{\%} CI, 6.0{\%} to 51.9{\%}). Reductions were most notable for HPV-31. Conclusions. HPV-6/11/16/18 vaccine reduced the risk of CIN2-3/AIS associated with nonvaccine types responsible for 20{\%} of cervical cancers. The clinical benefit of cross-protection is not expected to be fully additive to the efficacy already observed against HPV-6/11/16/18-related disease, because women may have >1 CIN lesion, each associated with a different HPV type. Trial registration. ClinicalTrials.gov identifiers: NCT00092521, NCT00092534, and NCT00092482.",
author = "Darron Brown and Kjaer, {Susanne K.} and Kristj{\'a}n Sigurdsson and Iversen, {Ole Erik} and Mauricio, {Hernandez Avila} and Wheeler, {Cosette M.} and Gonzalo Perez and Koutsky, {Laura A.} and Tay, {Eng Hseon} and Patric{\'i}a Garcia 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 Sings, {Heather L.} and Margaret James and Hesley, {Teresa M.} and Eliav Barra",
year = "2009",
month = "4",
day = "1",
doi = "10.1086/597307",
language = "English",
volume = "199",
pages = "926--935",
journal = "Journal of Infectious Diseases",
issn = "0022-1899",
publisher = "Oxford University Press",
number = "7",

}

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 generally HPV-naive women aged 16-26 years

AU - Brown, Darron

AU - Kjaer, Susanne K.

AU - Sigurdsson, Kristján

AU - Iversen, Ole Erik

AU - Mauricio, Hernandez Avila

AU - Wheeler, Cosette M.

AU - Perez, Gonzalo

AU - Koutsky, Laura A.

AU - Tay, Eng Hseon

AU - Garcia, Patricía

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 - Sings, Heather L.

AU - James, Margaret

AU - Hesley, Teresa M.

AU - Barra, Eliav

PY - 2009/4/1

Y1 - 2009/4/1

N2 - Background. Human papillomavirus (HPV)-6/11/16/18 vaccine reduces the risk of HPV-6/11/16/18-related cervical intraepithelial neoplasia (CIN) 1-3 or adenocarcinoma in situ (AIS). Here, its impact on CIN1-3/AIS associated with nonvaccine oncogenic HPV types was evaluated. Methods. We enrolled 17,622 women aged 16-26 years. All underwent cervicovaginal sampling and Pap testing at regular intervals for up to 4 years. HPV genotying was performed for biopsy samples, and histological diagnoses were determined by a pathology panel. Analyses were conducted among subjects who were negative for 14 HPV types on day 1. Prespecified analyses included infection of-6 months' duration and CIN1-3/AIS due to the 2 and 5 most common HPV types in cervical cancer after HPV types 16 and 18, as well as all tested nonvaccine types. Results. Vaccination reduced the incidence of HPV-31/45 infection by 40.3% (95% confidence interval [CI], 13.9% to 59.0%) and of CIN1-3/AIS by 43.6% (95% CI, 12.9% to 64.1%), respectively. The reduction in HPV-31/ 33/45/52/58 infection and CIN1-3/AIS was 25.0% (95% CI, 5.0% to 40.9%) and 29.2% (95% CI, 8.3% to 45.5%), respectively. Efficacy for CIN2-3/AIS associated with the 10 nonvaccine HPV types was 32.5% (95% CI, 6.0% to 51.9%). Reductions were most notable for HPV-31. Conclusions. HPV-6/11/16/18 vaccine reduced the risk of CIN2-3/AIS associated with nonvaccine types responsible for 20% of cervical cancers. The clinical benefit of cross-protection is not expected to be fully additive to the efficacy already observed against HPV-6/11/16/18-related disease, because women may have >1 CIN lesion, each associated with a different HPV type. Trial registration. ClinicalTrials.gov identifiers: NCT00092521, NCT00092534, and NCT00092482.

AB - Background. Human papillomavirus (HPV)-6/11/16/18 vaccine reduces the risk of HPV-6/11/16/18-related cervical intraepithelial neoplasia (CIN) 1-3 or adenocarcinoma in situ (AIS). Here, its impact on CIN1-3/AIS associated with nonvaccine oncogenic HPV types was evaluated. Methods. We enrolled 17,622 women aged 16-26 years. All underwent cervicovaginal sampling and Pap testing at regular intervals for up to 4 years. HPV genotying was performed for biopsy samples, and histological diagnoses were determined by a pathology panel. Analyses were conducted among subjects who were negative for 14 HPV types on day 1. Prespecified analyses included infection of-6 months' duration and CIN1-3/AIS due to the 2 and 5 most common HPV types in cervical cancer after HPV types 16 and 18, as well as all tested nonvaccine types. Results. Vaccination reduced the incidence of HPV-31/45 infection by 40.3% (95% confidence interval [CI], 13.9% to 59.0%) and of CIN1-3/AIS by 43.6% (95% CI, 12.9% to 64.1%), respectively. The reduction in HPV-31/ 33/45/52/58 infection and CIN1-3/AIS was 25.0% (95% CI, 5.0% to 40.9%) and 29.2% (95% CI, 8.3% to 45.5%), respectively. Efficacy for CIN2-3/AIS associated with the 10 nonvaccine HPV types was 32.5% (95% CI, 6.0% to 51.9%). Reductions were most notable for HPV-31. Conclusions. HPV-6/11/16/18 vaccine reduced the risk of CIN2-3/AIS associated with nonvaccine types responsible for 20% of cervical cancers. The clinical benefit of cross-protection is not expected to be fully additive to the efficacy already observed against HPV-6/11/16/18-related disease, because women may have >1 CIN lesion, each associated with a different HPV type. Trial registration. ClinicalTrials.gov identifiers: NCT00092521, NCT00092534, and NCT00092482.

UR - http://www.scopus.com/inward/record.url?scp=65549109389&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=65549109389&partnerID=8YFLogxK

U2 - 10.1086/597307

DO - 10.1086/597307

M3 - Article

VL - 199

SP - 926

EP - 935

JO - Journal of Infectious Diseases

JF - Journal of Infectious Diseases

SN - 0022-1899

IS - 7

ER -