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 R Brown; Susanne K Kjaer; Kristján Sigurdsson; Ole-Erik Iversen; Mauricio Hernandez-Avila; 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; 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 Barr

doi:10.1086/597307

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 R Brown, Susanne K Kjaer, Kristján Sigurdsson, Ole-Erik Iversen, Mauricio Hernandez-Avila, 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 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, Heather L Sings, Margaret James, Teresa M Hesley, Eliav Barr

513 Citationer (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 genotyping 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 approximately 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.

Originalsprog	Engelsk
Tidsskrift	The Journal of infectious diseases
Vol/bind	199
Udgave nummer	7
Sider (fra-til)	926-35
Antal sider	10
ISSN	0022-1899
DOI	https://doi.org/10.1086/597307
Status	Udgivet - 1 apr. 2009
Udgivet eksternt	Ja

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Citationsformater

Brown, D. R., Kjaer, S. K., Sigurdsson, K., Iversen, O.-E., Hernandez-Avila, M., Wheeler, C. M., Perez, G., Koutsky, L. A., Tay, E. H., Garcia, P., Ault, K. A., Garland, S. M., Leodolter, S., Olsson, S.-E., Tang, G. W. K., Ferris, D. G., Paavonen, J., Steben, M., Bosch, F. X., ... Barr, 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. The Journal of infectious diseases, 199(7), 926-35. https://doi.org/10.1086/597307

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 R; Kjaer, Susanne K; Sigurdsson, Kristján et al.
I: The Journal of infectious diseases, Bind 199, Nr. 7, 01.04.2009, s. 926-35.

Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › peer review

Brown, DR, Kjaer, SK, Sigurdsson, K, Iversen, O-E, Hernandez-Avila, M, Wheeler, CM, Perez, G, Koutsky, LA, Tay, EH, Garcia, P, Ault, KA, Garland, SM, Leodolter, S, Olsson, S-E, 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 & Barr, 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', The Journal of infectious diseases, bind 199, nr. 7, s. 926-35. https://doi.org/10.1086/597307

Brown DR, Kjaer SK, Sigurdsson K, Iversen OE, Hernandez-Avila M, Wheeler CM et al. 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. The Journal of infectious diseases. 2009 apr. 1;199(7):926-35. doi: 10.1086/597307

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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 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 genotyping 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 approximately 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.",

keywords = "Adolescent, Adult, Alphapapillomavirus/classification, Female, Humans, Papillomavirus Infections/prevention & control, Papillomavirus Vaccines, Uterine Cervical Neoplasms/prevention & control, Young Adult",

author = "Brown, {Darron R} and Kjaer, {Susanne K} and Kristj{\'a}n Sigurdsson and Ole-Erik Iversen 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 Sven-Eric Olsson 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 Barr",

year = "2009",

month = apr,

day = "1",

doi = "10.1086/597307",

language = "English",

volume = "199",

pages = "926--35",

journal = "The Journal of infectious diseases",

issn = "0022-1899",

publisher = "Oxford University Press",

number = "7",

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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 generally HPV-naive women aged 16-26 years

AU - Brown, Darron R

AU - Kjaer, Susanne K

AU - Sigurdsson, Kristján

AU - Iversen, Ole-Erik

AU - Hernandez-Avila, Mauricio

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 - Barr, 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 genotyping 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 approximately 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 genotyping 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 approximately 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.

KW - Adolescent

KW - Adult

KW - Alphapapillomavirus/classification

KW - Female

KW - Humans

KW - Papillomavirus Infections/prevention & control

KW - Papillomavirus Vaccines

KW - Uterine Cervical Neoplasms/prevention & control

KW - Young Adult

U2 - 10.1086/597307

DO - 10.1086/597307

M3 - Journal article

C2 - 19236279

SN - 0022-1899

VL - 199

SP - 926

EP - 935

JO - The Journal of infectious diseases

JF - The Journal of infectious diseases

IS - 7

ER -