A pooled analysis of continued prophylactic efficacy of quadrivalent human papillomavirus (types 6/11/16/18) vaccine against high-grade cervical and external genital lesions

Susanne K. Kjaer, Kristján Sigurdsson, Ole Erik Iversen, Mauricio Hernandez-Avila, Cosette M. Wheeler, Gonzalo Perez, Darron R. Brown, Laura A. Koutsky, Hseon Tay Eng, Patricia García, Kevin A. Ault, Suzanne M. Garland, Sepp Leodolter, Sven Eric Olsson, Grace W.K. Tang, Daron Gale Ferris, Jorma Paavonen, Matti Lehtinen, Marc Steben, F. Xavier Bosch & 17 others Joakim Dillner, Elmar A. Joura, Slawomir Majewski, Nubia Muñoz, Evan R. Myers, Luisa L. Villa, Frank J. Taddeo, Christine Roberts, Amha Tadesse, Janine Bryan, Roger Maansson, Shuang Lu, Scott Vuocolo, Teresa M. Hesley, Alfred Saah, Eliav Barr, Richard M. Haupt

Research output: Contribution to journalArticle

217 Citations (Scopus)

Abstract

Quadrivalent human papillomavirus (HPV) vaccine has been shown to provide protection from HPV 6/11/16/18-related cervical, vaginal, and vulvar disease through 3 years. We provide an update on the efficacy of the quadrivalent HPV vaccine against high-grade cervical, vaginal, and vulvar lesions based on end-of-study data from three clinical trials. Additionally, we stratify vaccine efficacy by several baseline characteristics, including age, smoking status, and Papanicolaou (Pap) test results. A total of 18,174 females ages 16 to 26 years were randomized and allocated into one of three clinical trials (protocols 007, 013, and 015). Vaccine or placebo was given at baseline, month 2, and month 6. Pap testing was conducted at regular intervals. Cervical and anogenital swabs were collected for HPV DNA testing. Examination for the presence of vulvar and vaginal lesions was also done. Endpoints included high-grade cervical, vulvar, or vaginal lesions (CIN 2/3, VIN 2/3, or ValN 2/3). Mean follow-up time was 42 months post dose 1. Vaccine efficacy against HPV 6/11/16/18-related high-grade cervical lesions in the per-protocol and intention-to-treat populations was 98.2% [95% confidence interval (95% CI), 93.3-99.8] and 51.5% (95% CI, 40.6-60.6), respectively. Vaccine efficacy against HPV 6/11/16/18-related high-grade vulvar and vaginal lesions in the per-protocol and intention-to-treat populations was 100.0% (95% CI, 82.6-100.0) and 79.0% (95% CI, 56.4-91.0), respectively. Efficacy in the intention-to-treat population tended to be lower in older women, women with more partners, and women with abnormal Pap test results. The efficacy of quadrivalent HPV vaccine against high-grade cervical and external anogenital neoplasia remains high through 42 months post vaccination.

Original languageEnglish (US)
Pages (from-to)868-878
Number of pages11
JournalCancer Prevention Research
Volume2
Issue number10
DOIs
StatePublished - Oct 1 2009

Fingerprint

Human papillomavirus 11
Human papillomavirus 6
Papillomavirus Vaccines
Vaccines
Confidence Intervals
Papanicolaou Test
Clinical Protocols
Vaginal Diseases
Vulvar Diseases
Clinical Trials
Population
Vaccination
Smoking
Placebos
DNA
Neoplasms

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

A pooled analysis of continued prophylactic efficacy of quadrivalent human papillomavirus (types 6/11/16/18) vaccine against high-grade cervical and external genital lesions. / Kjaer, Susanne K.; Sigurdsson, Kristján; Iversen, Ole Erik; Hernandez-Avila, Mauricio; Wheeler, Cosette M.; Perez, Gonzalo; Brown, Darron R.; Koutsky, Laura A.; Eng, Hseon Tay; García, Patricia; Ault, Kevin A.; Garland, Suzanne M.; Leodolter, Sepp; Olsson, Sven Eric; Tang, Grace W.K.; Ferris, Daron Gale; Paavonen, Jorma; Lehtinen, Matti; Steben, Marc; Bosch, F. Xavier; Dillner, Joakim; Joura, Elmar A.; Majewski, Slawomir; Muñoz, Nubia; Myers, Evan R.; Villa, Luisa L.; Taddeo, Frank J.; Roberts, Christine; Tadesse, Amha; Bryan, Janine; Maansson, Roger; Lu, Shuang; Vuocolo, Scott; Hesley, Teresa M.; Saah, Alfred; Barr, Eliav; Haupt, Richard M.

In: Cancer Prevention Research, Vol. 2, No. 10, 01.10.2009, p. 868-878.

Research output: Contribution to journalArticle

Kjaer, SK, Sigurdsson, K, Iversen, OE, Hernandez-Avila, M, Wheeler, CM, Perez, G, Brown, DR, Koutsky, LA, Eng, HT, García, P, Ault, KA, Garland, SM, Leodolter, S, Olsson, SE, Tang, GWK, Ferris, DG, Paavonen, J, Lehtinen, M, Steben, M, Bosch, FX, Dillner, J, Joura, EA, Majewski, S, Muñoz, N, Myers, ER, Villa, LL, Taddeo, FJ, Roberts, C, Tadesse, A, Bryan, J, Maansson, R, Lu, S, Vuocolo, S, Hesley, TM, Saah, A, Barr, E & Haupt, RM 2009, 'A pooled analysis of continued prophylactic efficacy of quadrivalent human papillomavirus (types 6/11/16/18) vaccine against high-grade cervical and external genital lesions', Cancer Prevention Research, vol. 2, no. 10, pp. 868-878. https://doi.org/10.1158/1940-6207.CAPR-09-0031
Kjaer, Susanne K. ; Sigurdsson, Kristján ; Iversen, Ole Erik ; Hernandez-Avila, Mauricio ; Wheeler, Cosette M. ; Perez, Gonzalo ; Brown, Darron R. ; Koutsky, Laura A. ; Eng, Hseon Tay ; García, Patricia ; Ault, Kevin A. ; Garland, Suzanne M. ; Leodolter, Sepp ; Olsson, Sven Eric ; Tang, Grace W.K. ; Ferris, Daron Gale ; Paavonen, Jorma ; Lehtinen, Matti ; Steben, Marc ; Bosch, F. Xavier ; Dillner, Joakim ; Joura, Elmar A. ; Majewski, Slawomir ; Muñoz, Nubia ; Myers, Evan R. ; Villa, Luisa L. ; Taddeo, Frank J. ; Roberts, Christine ; Tadesse, Amha ; Bryan, Janine ; Maansson, Roger ; Lu, Shuang ; Vuocolo, Scott ; Hesley, Teresa M. ; Saah, Alfred ; Barr, Eliav ; Haupt, Richard M. / A pooled analysis of continued prophylactic efficacy of quadrivalent human papillomavirus (types 6/11/16/18) vaccine against high-grade cervical and external genital lesions. In: Cancer Prevention Research. 2009 ; Vol. 2, No. 10. pp. 868-878.
@article{8922ceb8c07144f6926ac3c22a92fc0d,
title = "A pooled analysis of continued prophylactic efficacy of quadrivalent human papillomavirus (types 6/11/16/18) vaccine against high-grade cervical and external genital lesions",
abstract = "Quadrivalent human papillomavirus (HPV) vaccine has been shown to provide protection from HPV 6/11/16/18-related cervical, vaginal, and vulvar disease through 3 years. We provide an update on the efficacy of the quadrivalent HPV vaccine against high-grade cervical, vaginal, and vulvar lesions based on end-of-study data from three clinical trials. Additionally, we stratify vaccine efficacy by several baseline characteristics, including age, smoking status, and Papanicolaou (Pap) test results. A total of 18,174 females ages 16 to 26 years were randomized and allocated into one of three clinical trials (protocols 007, 013, and 015). Vaccine or placebo was given at baseline, month 2, and month 6. Pap testing was conducted at regular intervals. Cervical and anogenital swabs were collected for HPV DNA testing. Examination for the presence of vulvar and vaginal lesions was also done. Endpoints included high-grade cervical, vulvar, or vaginal lesions (CIN 2/3, VIN 2/3, or ValN 2/3). Mean follow-up time was 42 months post dose 1. Vaccine efficacy against HPV 6/11/16/18-related high-grade cervical lesions in the per-protocol and intention-to-treat populations was 98.2{\%} [95{\%} confidence interval (95{\%} CI), 93.3-99.8] and 51.5{\%} (95{\%} CI, 40.6-60.6), respectively. Vaccine efficacy against HPV 6/11/16/18-related high-grade vulvar and vaginal lesions in the per-protocol and intention-to-treat populations was 100.0{\%} (95{\%} CI, 82.6-100.0) and 79.0{\%} (95{\%} CI, 56.4-91.0), respectively. Efficacy in the intention-to-treat population tended to be lower in older women, women with more partners, and women with abnormal Pap test results. The efficacy of quadrivalent HPV vaccine against high-grade cervical and external anogenital neoplasia remains high through 42 months post vaccination.",
author = "Kjaer, {Susanne K.} and Kristj{\'a}n Sigurdsson and Iversen, {Ole Erik} and Mauricio Hernandez-Avila and Wheeler, {Cosette M.} and Gonzalo Perez and Brown, {Darron R.} and Koutsky, {Laura A.} and Eng, {Hseon Tay} 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 Gale} and Jorma Paavonen and Matti Lehtinen and Marc Steben and Bosch, {F. Xavier} and Joakim Dillner and Joura, {Elmar A.} 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 Roger Maansson and Shuang Lu and Scott Vuocolo and Hesley, {Teresa M.} and Alfred Saah and Eliav Barr and Haupt, {Richard M.}",
year = "2009",
month = "10",
day = "1",
doi = "10.1158/1940-6207.CAPR-09-0031",
language = "English (US)",
volume = "2",
pages = "868--878",
journal = "Cancer Prevention Research",
issn = "1940-6207",
publisher = "American Association for Cancer Research Inc.",
number = "10",

}

TY - JOUR

T1 - A pooled analysis of continued prophylactic efficacy of quadrivalent human papillomavirus (types 6/11/16/18) vaccine against high-grade cervical and external genital lesions

AU - Kjaer, Susanne K.

AU - Sigurdsson, Kristján

AU - Iversen, Ole Erik

AU - Hernandez-Avila, Mauricio

AU - Wheeler, Cosette M.

AU - Perez, Gonzalo

AU - Brown, Darron R.

AU - Koutsky, Laura A.

AU - Eng, Hseon Tay

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 Gale

AU - Paavonen, Jorma

AU - Lehtinen, Matti

AU - Steben, Marc

AU - Bosch, F. Xavier

AU - Dillner, Joakim

AU - Joura, Elmar A.

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 - Maansson, Roger

AU - Lu, Shuang

AU - Vuocolo, Scott

AU - Hesley, Teresa M.

AU - Saah, Alfred

AU - Barr, Eliav

AU - Haupt, Richard M.

PY - 2009/10/1

Y1 - 2009/10/1

N2 - Quadrivalent human papillomavirus (HPV) vaccine has been shown to provide protection from HPV 6/11/16/18-related cervical, vaginal, and vulvar disease through 3 years. We provide an update on the efficacy of the quadrivalent HPV vaccine against high-grade cervical, vaginal, and vulvar lesions based on end-of-study data from three clinical trials. Additionally, we stratify vaccine efficacy by several baseline characteristics, including age, smoking status, and Papanicolaou (Pap) test results. A total of 18,174 females ages 16 to 26 years were randomized and allocated into one of three clinical trials (protocols 007, 013, and 015). Vaccine or placebo was given at baseline, month 2, and month 6. Pap testing was conducted at regular intervals. Cervical and anogenital swabs were collected for HPV DNA testing. Examination for the presence of vulvar and vaginal lesions was also done. Endpoints included high-grade cervical, vulvar, or vaginal lesions (CIN 2/3, VIN 2/3, or ValN 2/3). Mean follow-up time was 42 months post dose 1. Vaccine efficacy against HPV 6/11/16/18-related high-grade cervical lesions in the per-protocol and intention-to-treat populations was 98.2% [95% confidence interval (95% CI), 93.3-99.8] and 51.5% (95% CI, 40.6-60.6), respectively. Vaccine efficacy against HPV 6/11/16/18-related high-grade vulvar and vaginal lesions in the per-protocol and intention-to-treat populations was 100.0% (95% CI, 82.6-100.0) and 79.0% (95% CI, 56.4-91.0), respectively. Efficacy in the intention-to-treat population tended to be lower in older women, women with more partners, and women with abnormal Pap test results. The efficacy of quadrivalent HPV vaccine against high-grade cervical and external anogenital neoplasia remains high through 42 months post vaccination.

AB - Quadrivalent human papillomavirus (HPV) vaccine has been shown to provide protection from HPV 6/11/16/18-related cervical, vaginal, and vulvar disease through 3 years. We provide an update on the efficacy of the quadrivalent HPV vaccine against high-grade cervical, vaginal, and vulvar lesions based on end-of-study data from three clinical trials. Additionally, we stratify vaccine efficacy by several baseline characteristics, including age, smoking status, and Papanicolaou (Pap) test results. A total of 18,174 females ages 16 to 26 years were randomized and allocated into one of three clinical trials (protocols 007, 013, and 015). Vaccine or placebo was given at baseline, month 2, and month 6. Pap testing was conducted at regular intervals. Cervical and anogenital swabs were collected for HPV DNA testing. Examination for the presence of vulvar and vaginal lesions was also done. Endpoints included high-grade cervical, vulvar, or vaginal lesions (CIN 2/3, VIN 2/3, or ValN 2/3). Mean follow-up time was 42 months post dose 1. Vaccine efficacy against HPV 6/11/16/18-related high-grade cervical lesions in the per-protocol and intention-to-treat populations was 98.2% [95% confidence interval (95% CI), 93.3-99.8] and 51.5% (95% CI, 40.6-60.6), respectively. Vaccine efficacy against HPV 6/11/16/18-related high-grade vulvar and vaginal lesions in the per-protocol and intention-to-treat populations was 100.0% (95% CI, 82.6-100.0) and 79.0% (95% CI, 56.4-91.0), respectively. Efficacy in the intention-to-treat population tended to be lower in older women, women with more partners, and women with abnormal Pap test results. The efficacy of quadrivalent HPV vaccine against high-grade cervical and external anogenital neoplasia remains high through 42 months post vaccination.

UR - http://www.scopus.com/inward/record.url?scp=70449338341&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=70449338341&partnerID=8YFLogxK

U2 - 10.1158/1940-6207.CAPR-09-0031

DO - 10.1158/1940-6207.CAPR-09-0031

M3 - Article

VL - 2

SP - 868

EP - 878

JO - Cancer Prevention Research

JF - Cancer Prevention Research

SN - 1940-6207

IS - 10

ER -