Impact of Human Papillomavirus (HPV)-6/11/16/18 Vaccine on All HPV-Associated Genital Diseases in Young Women

Nubia Munoz, Susanne K. Kjaer, Kristján Sigurdsson, Ole Erik Iversen, Mauricio Hernandez-Avila, Cosette M. Wheeler, Gonzalo Perez, Darron R. Brown, Laura A. Koutsky, Eng Hseon Tay, Patricía J. Garcia, Kevin A. Ault, Suzanne M. Garland, Sepp Leodolter, Sven Eric Olsson, Grace W.K. Tang, Daron Gale Ferris, Jorma Paavonen, Marc Steben, F. Xavier BoschJoakim Dillner, Warner K. Huh, Elmar A. Joura, Robert J. Kurman, Slawomir Majewski, Evan R. Myers, Luisa L. Villa, Frank J. Taddeo, Christine Roberts, Amha Tadesse, Janine T. Bryan, Lisa C. Lupinacci, Katherine E.D. Giacoletti, Heather L. Sings, Margaret K. James, Teresa M. Hesley, Eliav Barr, Richard M. Haupt

Research output: Contribution to journalArticle

393 Citations (Scopus)

Abstract

Background The impact of the prophylactic vaccine against human papillomavirus (HPV) types 6, 11, 16, and 18 (HPV6/11/16/18) on all HPV-associated genital disease was investigated in a population that approximates sexually naive women in that they were "negative to 14 HPV types" and in a mixed population of HPV-exposed and-unexposed women (intention-to-treat group).MethodsThis analysis studied 17 622 women aged 15-26 years who were enrolled in one of two randomized, placebo-controlled, efficacy trials for the HPV6/11/16/18 vaccine (first patient on December 28, 2001, and studies completed July 31, 2007). Vaccine or placebo was given at day 1, month 2, and month 6. All women underwent cervicovaginal sampling and Papanicolaou (Pap) testing at day 1 and every 6-12 months thereafter. Outcomes were any cervical intraepithelial neoplasia; any external anogenital and vaginal lesions; Pap test abnormalities; and procedures such as colposcopy and definitive therapy. Absolute rates are expressed as women with endpoint per 100 person-years at risk.ResultsThe average follow-up was 3.6 years (maximum of 4.9 years). In the population that was negative to 14 HPV types, vaccination was up to 100% effective in reducing the risk of HPV16/18-related high-grade cervical, vulvar, and vaginal lesions and of HPV6/11-related genital warts. In the intention-to-treat group, vaccination also statistically significantly reduced the risk of any high-grade cervical lesions (19.0% reduction; rate vaccine = 1.43, rate placebo = 1.76, difference = 0.33, 95% confidence interval [CI] = 0.13 to 0.54), vulvar and vaginal lesions (50.7% reduction; rate vaccine = 0.10, rate placebo = 0.20, difference = 0.10, 95% CI = 0.04 to 0.16), genital warts (62.0% reduction; rate vaccine = 0.44, rate placebo = 1.17, difference = 0.72, 95% CI = 0.58 to 0.87), Pap abnormalities (11.3% reduction; rate vaccine = 10.36, rate placebo = 11.68, difference = 1.32, 95% CI = 0.74 to 1.90), and cervical definitive therapy (23.0% reduction; rate vaccine = 1.97, rate placebo = 2.56, difference = 0.59, 95% CI = 0.35 to 0.83), irrespective of causal HPV type.ConclusionsHigh-coverage HPV vaccination programs among adolescents and young women may result in a rapid reduction of genital warts, cervical cytological abnormalities, and diagnostic and therapeutic procedures. In the longer term, substantial reductions in the rates of cervical, vulvar, and vaginal cancers may follow.

Original languageEnglish (US)
Pages (from-to)325-339
Number of pages15
JournalJournal of the National Cancer Institute
Volume102
Issue number5
DOIs
StatePublished - Mar 1 2010

Fingerprint

Human papillomavirus 11
Human papillomavirus 6
Vaccines
Placebos
Condylomata Acuminata
Confidence Intervals
Vaccination
Vaginal Neoplasms
Vulvar Neoplasms
Population
Papanicolaou Test
Colposcopy
Cervical Intraepithelial Neoplasia
Uterine Cervical Neoplasms
Therapeutics

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

Munoz, N., Kjaer, S. K., Sigurdsson, K., Iversen, O. E., Hernandez-Avila, M., Wheeler, C. M., ... Haupt, R. M. (2010). Impact of Human Papillomavirus (HPV)-6/11/16/18 Vaccine on All HPV-Associated Genital Diseases in Young Women. Journal of the National Cancer Institute, 102(5), 325-339. https://doi.org/10.1093/jnci/djp534

Impact of Human Papillomavirus (HPV)-6/11/16/18 Vaccine on All HPV-Associated Genital Diseases in Young Women. / Munoz, Nubia; Kjaer, Susanne K.; Sigurdsson, Kristján; Iversen, Ole Erik; Hernandez-Avila, Mauricio; Wheeler, Cosette M.; Perez, Gonzalo; Brown, Darron R.; Koutsky, Laura A.; Tay, Eng Hseon; Garcia, Patricía J.; Ault, Kevin A.; Garland, Suzanne M.; Leodolter, Sepp; Olsson, Sven Eric; Tang, Grace W.K.; Ferris, Daron Gale; Paavonen, Jorma; Steben, Marc; Bosch, F. Xavier; Dillner, Joakim; Huh, Warner K.; Joura, Elmar A.; Kurman, Robert J.; Majewski, Slawomir; Myers, Evan R.; Villa, Luisa L.; Taddeo, Frank J.; Roberts, Christine; Tadesse, Amha; Bryan, Janine T.; Lupinacci, Lisa C.; Giacoletti, Katherine E.D.; Sings, Heather L.; James, Margaret K.; Hesley, Teresa M.; Barr, Eliav; Haupt, Richard M.

In: Journal of the National Cancer Institute, Vol. 102, No. 5, 01.03.2010, p. 325-339.

Research output: Contribution to journalArticle

Munoz, N, Kjaer, SK, Sigurdsson, K, Iversen, OE, Hernandez-Avila, M, Wheeler, CM, Perez, G, Brown, DR, Koutsky, LA, Tay, EH, Garcia, PJ, Ault, KA, Garland, SM, Leodolter, S, Olsson, SE, Tang, GWK, Ferris, DG, Paavonen, J, Steben, M, Bosch, FX, Dillner, J, Huh, WK, Joura, EA, Kurman, RJ, Majewski, S, Myers, ER, Villa, LL, Taddeo, FJ, Roberts, C, Tadesse, A, Bryan, JT, Lupinacci, LC, Giacoletti, KED, Sings, HL, James, MK, Hesley, TM, Barr, E & Haupt, RM 2010, 'Impact of Human Papillomavirus (HPV)-6/11/16/18 Vaccine on All HPV-Associated Genital Diseases in Young Women', Journal of the National Cancer Institute, vol. 102, no. 5, pp. 325-339. https://doi.org/10.1093/jnci/djp534
Munoz, Nubia ; Kjaer, Susanne K. ; Sigurdsson, Kristján ; Iversen, Ole Erik ; Hernandez-Avila, Mauricio ; Wheeler, Cosette M. ; Perez, Gonzalo ; Brown, Darron R. ; Koutsky, Laura A. ; Tay, Eng Hseon ; Garcia, Patricía J. ; Ault, Kevin A. ; Garland, Suzanne M. ; Leodolter, Sepp ; Olsson, Sven Eric ; Tang, Grace W.K. ; Ferris, Daron Gale ; Paavonen, Jorma ; Steben, Marc ; Bosch, F. Xavier ; Dillner, Joakim ; Huh, Warner K. ; Joura, Elmar A. ; Kurman, Robert J. ; Majewski, Slawomir ; Myers, Evan R. ; Villa, Luisa L. ; Taddeo, Frank J. ; Roberts, Christine ; Tadesse, Amha ; Bryan, Janine T. ; Lupinacci, Lisa C. ; Giacoletti, Katherine E.D. ; Sings, Heather L. ; James, Margaret K. ; Hesley, Teresa M. ; Barr, Eliav ; Haupt, Richard M. / Impact of Human Papillomavirus (HPV)-6/11/16/18 Vaccine on All HPV-Associated Genital Diseases in Young Women. In: Journal of the National Cancer Institute. 2010 ; Vol. 102, No. 5. pp. 325-339.
@article{df4b4bc7ca2d492895cb4baa1e58912a,
title = "Impact of Human Papillomavirus (HPV)-6/11/16/18 Vaccine on All HPV-Associated Genital Diseases in Young Women",
abstract = "Background The impact of the prophylactic vaccine against human papillomavirus (HPV) types 6, 11, 16, and 18 (HPV6/11/16/18) on all HPV-associated genital disease was investigated in a population that approximates sexually naive women in that they were {"}negative to 14 HPV types{"} and in a mixed population of HPV-exposed and-unexposed women (intention-to-treat group).MethodsThis analysis studied 17 622 women aged 15-26 years who were enrolled in one of two randomized, placebo-controlled, efficacy trials for the HPV6/11/16/18 vaccine (first patient on December 28, 2001, and studies completed July 31, 2007). Vaccine or placebo was given at day 1, month 2, and month 6. All women underwent cervicovaginal sampling and Papanicolaou (Pap) testing at day 1 and every 6-12 months thereafter. Outcomes were any cervical intraepithelial neoplasia; any external anogenital and vaginal lesions; Pap test abnormalities; and procedures such as colposcopy and definitive therapy. Absolute rates are expressed as women with endpoint per 100 person-years at risk.ResultsThe average follow-up was 3.6 years (maximum of 4.9 years). In the population that was negative to 14 HPV types, vaccination was up to 100{\%} effective in reducing the risk of HPV16/18-related high-grade cervical, vulvar, and vaginal lesions and of HPV6/11-related genital warts. In the intention-to-treat group, vaccination also statistically significantly reduced the risk of any high-grade cervical lesions (19.0{\%} reduction; rate vaccine = 1.43, rate placebo = 1.76, difference = 0.33, 95{\%} confidence interval [CI] = 0.13 to 0.54), vulvar and vaginal lesions (50.7{\%} reduction; rate vaccine = 0.10, rate placebo = 0.20, difference = 0.10, 95{\%} CI = 0.04 to 0.16), genital warts (62.0{\%} reduction; rate vaccine = 0.44, rate placebo = 1.17, difference = 0.72, 95{\%} CI = 0.58 to 0.87), Pap abnormalities (11.3{\%} reduction; rate vaccine = 10.36, rate placebo = 11.68, difference = 1.32, 95{\%} CI = 0.74 to 1.90), and cervical definitive therapy (23.0{\%} reduction; rate vaccine = 1.97, rate placebo = 2.56, difference = 0.59, 95{\%} CI = 0.35 to 0.83), irrespective of causal HPV type.ConclusionsHigh-coverage HPV vaccination programs among adolescents and young women may result in a rapid reduction of genital warts, cervical cytological abnormalities, and diagnostic and therapeutic procedures. In the longer term, substantial reductions in the rates of cervical, vulvar, and vaginal cancers may follow.",
author = "Nubia Munoz 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 Brown, {Darron R.} and Koutsky, {Laura A.} and Tay, {Eng Hseon} and Garcia, {Patric{\'i}a J.} 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 Marc Steben and Bosch, {F. Xavier} and Joakim Dillner and Huh, {Warner K.} and Joura, {Elmar A.} and Kurman, {Robert J.} and Slawomir Majewski and Myers, {Evan R.} and Villa, {Luisa L.} and Taddeo, {Frank J.} and Christine Roberts and Amha Tadesse and Bryan, {Janine T.} and Lupinacci, {Lisa C.} and Giacoletti, {Katherine E.D.} and Sings, {Heather L.} and James, {Margaret K.} and Hesley, {Teresa M.} and Eliav Barr and Haupt, {Richard M.}",
year = "2010",
month = "3",
day = "1",
doi = "10.1093/jnci/djp534",
language = "English (US)",
volume = "102",
pages = "325--339",
journal = "Journal of the National Cancer Institute",
issn = "0027-8874",
publisher = "Oxford University Press",
number = "5",

}

TY - JOUR

T1 - Impact of Human Papillomavirus (HPV)-6/11/16/18 Vaccine on All HPV-Associated Genital Diseases in Young Women

AU - Munoz, Nubia

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 - Tay, Eng Hseon

AU - Garcia, Patricía J.

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 - Steben, Marc

AU - Bosch, F. Xavier

AU - Dillner, Joakim

AU - Huh, Warner K.

AU - Joura, Elmar A.

AU - Kurman, Robert J.

AU - Majewski, Slawomir

AU - Myers, Evan R.

AU - Villa, Luisa L.

AU - Taddeo, Frank J.

AU - Roberts, Christine

AU - Tadesse, Amha

AU - Bryan, Janine T.

AU - Lupinacci, Lisa C.

AU - Giacoletti, Katherine E.D.

AU - Sings, Heather L.

AU - James, Margaret K.

AU - Hesley, Teresa M.

AU - Barr, Eliav

AU - Haupt, Richard M.

PY - 2010/3/1

Y1 - 2010/3/1

N2 - Background The impact of the prophylactic vaccine against human papillomavirus (HPV) types 6, 11, 16, and 18 (HPV6/11/16/18) on all HPV-associated genital disease was investigated in a population that approximates sexually naive women in that they were "negative to 14 HPV types" and in a mixed population of HPV-exposed and-unexposed women (intention-to-treat group).MethodsThis analysis studied 17 622 women aged 15-26 years who were enrolled in one of two randomized, placebo-controlled, efficacy trials for the HPV6/11/16/18 vaccine (first patient on December 28, 2001, and studies completed July 31, 2007). Vaccine or placebo was given at day 1, month 2, and month 6. All women underwent cervicovaginal sampling and Papanicolaou (Pap) testing at day 1 and every 6-12 months thereafter. Outcomes were any cervical intraepithelial neoplasia; any external anogenital and vaginal lesions; Pap test abnormalities; and procedures such as colposcopy and definitive therapy. Absolute rates are expressed as women with endpoint per 100 person-years at risk.ResultsThe average follow-up was 3.6 years (maximum of 4.9 years). In the population that was negative to 14 HPV types, vaccination was up to 100% effective in reducing the risk of HPV16/18-related high-grade cervical, vulvar, and vaginal lesions and of HPV6/11-related genital warts. In the intention-to-treat group, vaccination also statistically significantly reduced the risk of any high-grade cervical lesions (19.0% reduction; rate vaccine = 1.43, rate placebo = 1.76, difference = 0.33, 95% confidence interval [CI] = 0.13 to 0.54), vulvar and vaginal lesions (50.7% reduction; rate vaccine = 0.10, rate placebo = 0.20, difference = 0.10, 95% CI = 0.04 to 0.16), genital warts (62.0% reduction; rate vaccine = 0.44, rate placebo = 1.17, difference = 0.72, 95% CI = 0.58 to 0.87), Pap abnormalities (11.3% reduction; rate vaccine = 10.36, rate placebo = 11.68, difference = 1.32, 95% CI = 0.74 to 1.90), and cervical definitive therapy (23.0% reduction; rate vaccine = 1.97, rate placebo = 2.56, difference = 0.59, 95% CI = 0.35 to 0.83), irrespective of causal HPV type.ConclusionsHigh-coverage HPV vaccination programs among adolescents and young women may result in a rapid reduction of genital warts, cervical cytological abnormalities, and diagnostic and therapeutic procedures. In the longer term, substantial reductions in the rates of cervical, vulvar, and vaginal cancers may follow.

AB - Background The impact of the prophylactic vaccine against human papillomavirus (HPV) types 6, 11, 16, and 18 (HPV6/11/16/18) on all HPV-associated genital disease was investigated in a population that approximates sexually naive women in that they were "negative to 14 HPV types" and in a mixed population of HPV-exposed and-unexposed women (intention-to-treat group).MethodsThis analysis studied 17 622 women aged 15-26 years who were enrolled in one of two randomized, placebo-controlled, efficacy trials for the HPV6/11/16/18 vaccine (first patient on December 28, 2001, and studies completed July 31, 2007). Vaccine or placebo was given at day 1, month 2, and month 6. All women underwent cervicovaginal sampling and Papanicolaou (Pap) testing at day 1 and every 6-12 months thereafter. Outcomes were any cervical intraepithelial neoplasia; any external anogenital and vaginal lesions; Pap test abnormalities; and procedures such as colposcopy and definitive therapy. Absolute rates are expressed as women with endpoint per 100 person-years at risk.ResultsThe average follow-up was 3.6 years (maximum of 4.9 years). In the population that was negative to 14 HPV types, vaccination was up to 100% effective in reducing the risk of HPV16/18-related high-grade cervical, vulvar, and vaginal lesions and of HPV6/11-related genital warts. In the intention-to-treat group, vaccination also statistically significantly reduced the risk of any high-grade cervical lesions (19.0% reduction; rate vaccine = 1.43, rate placebo = 1.76, difference = 0.33, 95% confidence interval [CI] = 0.13 to 0.54), vulvar and vaginal lesions (50.7% reduction; rate vaccine = 0.10, rate placebo = 0.20, difference = 0.10, 95% CI = 0.04 to 0.16), genital warts (62.0% reduction; rate vaccine = 0.44, rate placebo = 1.17, difference = 0.72, 95% CI = 0.58 to 0.87), Pap abnormalities (11.3% reduction; rate vaccine = 10.36, rate placebo = 11.68, difference = 1.32, 95% CI = 0.74 to 1.90), and cervical definitive therapy (23.0% reduction; rate vaccine = 1.97, rate placebo = 2.56, difference = 0.59, 95% CI = 0.35 to 0.83), irrespective of causal HPV type.ConclusionsHigh-coverage HPV vaccination programs among adolescents and young women may result in a rapid reduction of genital warts, cervical cytological abnormalities, and diagnostic and therapeutic procedures. In the longer term, substantial reductions in the rates of cervical, vulvar, and vaginal cancers may follow.

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JF - Journal of the National Cancer Institute

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