Prophylactic efficacy of a quadrivalent human papillomavirus (HPV) vaccine in women with virological evidence of HPV Infection

Luisa L. Villa, Gonzalo Perez, Susanne Krüger Kjær, Jorma Paavonen, Matti Lehtinen, Nubia Muñoz, Kristján Sigurdsson, Mauricio Hernandez-Avila, Ole Eric Iversen, Steinar Thoresen, Patricia J. García, Slawomir Majewski, Hseon Tay Eng, F. Xavier Bosch, Joakim Dillner, Sven Eric Olsson, Kevin A. Ault, Darron R. Brown, Daron Gale Ferris, Laura A. KoutskyRobert J. Kurman, Evan R. Myers, Eliav Barr, John Boslego, Janine Bryan, Mark T. Esser, Teresa M. Hesley, Micki Nelson, Radha Railkar, Margaret James, Carlos Sattler, Frank J. Taddeo, Annemarie R. Thornton, Scott C. Vuocolo

Research output: Contribution to journalArticle

134 Citations (Scopus)

Abstract

Background. A quadrivalent (types 6, 11, 16, and 18) human papillomavirus (HPV) L1 virus-like-particle (VLP) vaccine has been shown to be 95%-100% effective in preventing cervical and genital disease related to HPV-6, -11, -16, and -18 in 16-26-year-old women naive for HPV vaccine types. Because most women in the general population are sexually active, some will have already been infected with ≥1 HPV vaccine types at the time vaccination is offered. Here, we assessed whether such infected women are protected against disease caused by the remaining HPV vaccine types. Methods. Two randomized, placebo-controlled trials of the quadrivalent (types 6, 11, 16, and 18) HPV vaccine enrolled 17,622 women without consideration of baseline HPV status. Among women infected with 1-3 HPV vaccine types at enrollment, efficacy against genital disease related to the HPV vaccine type or types for which subjects were naive was assessed. Results. Vaccination was 100% effective (95% confidence interval [CI], 79%-100%) in preventing incident cervical intraepithelial neoplasia 2 or 3 or cervical adenocarcinoma in situ caused by the HPV type or types for which the women were negative at enrollment. Efficacy for preventing vulvar or vaginal HPV-related lesions was 94% (95% CI, 81%-99%). Conclusions. Among women positive for 1-3 HPV vaccine types before vaccination, the quadrivalent HPV vaccine protected against neoplasia caused by the remaining types. These results support vaccination of the general population without prescreening.

Original languageEnglish (US)
Pages (from-to)1438-1446
Number of pages9
JournalJournal of Infectious Diseases
Volume196
Issue number10
DOIs
StatePublished - Nov 15 2007

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Papillomavirus Vaccines
Papillomavirus Infections
Vaccination
Papillomaviridae
Virus-Like Particle Vaccines
Confidence Intervals
Human papillomavirus 11
Human papillomavirus 6
Cervical Intraepithelial Neoplasia
Population
Randomized Controlled Trials
Placebos

ASJC Scopus subject areas

  • Immunology and Allergy
  • Infectious Diseases

Cite this

Villa, L. L., Perez, G., Kjær, S. K., Paavonen, J., Lehtinen, M., Muñoz, N., ... Vuocolo, S. C. (2007). Prophylactic efficacy of a quadrivalent human papillomavirus (HPV) vaccine in women with virological evidence of HPV Infection. Journal of Infectious Diseases, 196(10), 1438-1446. https://doi.org/10.1086/522864

Prophylactic efficacy of a quadrivalent human papillomavirus (HPV) vaccine in women with virological evidence of HPV Infection. / Villa, Luisa L.; Perez, Gonzalo; Kjær, Susanne Krüger; Paavonen, Jorma; Lehtinen, Matti; Muñoz, Nubia; Sigurdsson, Kristján; Hernandez-Avila, Mauricio; Iversen, Ole Eric; Thoresen, Steinar; García, Patricia J.; Majewski, Slawomir; Eng, Hseon Tay; Bosch, F. Xavier; Dillner, Joakim; Olsson, Sven Eric; Ault, Kevin A.; Brown, Darron R.; Ferris, Daron Gale; Koutsky, Laura A.; Kurman, Robert J.; Myers, Evan R.; Barr, Eliav; Boslego, John; Bryan, Janine; Esser, Mark T.; Hesley, Teresa M.; Nelson, Micki; Railkar, Radha; James, Margaret; Sattler, Carlos; Taddeo, Frank J.; Thornton, Annemarie R.; Vuocolo, Scott C.

In: Journal of Infectious Diseases, Vol. 196, No. 10, 15.11.2007, p. 1438-1446.

Research output: Contribution to journalArticle

Villa, LL, Perez, G, Kjær, SK, Paavonen, J, Lehtinen, M, Muñoz, N, Sigurdsson, K, Hernandez-Avila, M, Iversen, OE, Thoresen, S, García, PJ, Majewski, S, Eng, HT, Bosch, FX, Dillner, J, Olsson, SE, Ault, KA, Brown, DR, Ferris, DG, Koutsky, LA, Kurman, RJ, Myers, ER, Barr, E, Boslego, J, Bryan, J, Esser, MT, Hesley, TM, Nelson, M, Railkar, R, James, M, Sattler, C, Taddeo, FJ, Thornton, AR & Vuocolo, SC 2007, 'Prophylactic efficacy of a quadrivalent human papillomavirus (HPV) vaccine in women with virological evidence of HPV Infection', Journal of Infectious Diseases, vol. 196, no. 10, pp. 1438-1446. https://doi.org/10.1086/522864
Villa, Luisa L. ; Perez, Gonzalo ; Kjær, Susanne Krüger ; Paavonen, Jorma ; Lehtinen, Matti ; Muñoz, Nubia ; Sigurdsson, Kristján ; Hernandez-Avila, Mauricio ; Iversen, Ole Eric ; Thoresen, Steinar ; García, Patricia J. ; Majewski, Slawomir ; Eng, Hseon Tay ; Bosch, F. Xavier ; Dillner, Joakim ; Olsson, Sven Eric ; Ault, Kevin A. ; Brown, Darron R. ; Ferris, Daron Gale ; Koutsky, Laura A. ; Kurman, Robert J. ; Myers, Evan R. ; Barr, Eliav ; Boslego, John ; Bryan, Janine ; Esser, Mark T. ; Hesley, Teresa M. ; Nelson, Micki ; Railkar, Radha ; James, Margaret ; Sattler, Carlos ; Taddeo, Frank J. ; Thornton, Annemarie R. ; Vuocolo, Scott C. / Prophylactic efficacy of a quadrivalent human papillomavirus (HPV) vaccine in women with virological evidence of HPV Infection. In: Journal of Infectious Diseases. 2007 ; Vol. 196, No. 10. pp. 1438-1446.
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title = "Prophylactic efficacy of a quadrivalent human papillomavirus (HPV) vaccine in women with virological evidence of HPV Infection",
abstract = "Background. A quadrivalent (types 6, 11, 16, and 18) human papillomavirus (HPV) L1 virus-like-particle (VLP) vaccine has been shown to be 95{\%}-100{\%} effective in preventing cervical and genital disease related to HPV-6, -11, -16, and -18 in 16-26-year-old women naive for HPV vaccine types. Because most women in the general population are sexually active, some will have already been infected with ≥1 HPV vaccine types at the time vaccination is offered. Here, we assessed whether such infected women are protected against disease caused by the remaining HPV vaccine types. Methods. Two randomized, placebo-controlled trials of the quadrivalent (types 6, 11, 16, and 18) HPV vaccine enrolled 17,622 women without consideration of baseline HPV status. Among women infected with 1-3 HPV vaccine types at enrollment, efficacy against genital disease related to the HPV vaccine type or types for which subjects were naive was assessed. Results. Vaccination was 100{\%} effective (95{\%} confidence interval [CI], 79{\%}-100{\%}) in preventing incident cervical intraepithelial neoplasia 2 or 3 or cervical adenocarcinoma in situ caused by the HPV type or types for which the women were negative at enrollment. Efficacy for preventing vulvar or vaginal HPV-related lesions was 94{\%} (95{\%} CI, 81{\%}-99{\%}). Conclusions. Among women positive for 1-3 HPV vaccine types before vaccination, the quadrivalent HPV vaccine protected against neoplasia caused by the remaining types. These results support vaccination of the general population without prescreening.",
author = "Villa, {Luisa L.} and Gonzalo Perez and Kj{\ae}r, {Susanne Kr{\"u}ger} and Jorma Paavonen and Matti Lehtinen and Nubia Mu{\~n}oz and Kristj{\'a}n Sigurdsson and Mauricio Hernandez-Avila and Iversen, {Ole Eric} and Steinar Thoresen and Garc{\'i}a, {Patricia J.} and Slawomir Majewski and Eng, {Hseon Tay} and Bosch, {F. Xavier} and Joakim Dillner and Olsson, {Sven Eric} and Ault, {Kevin A.} and Brown, {Darron R.} and Ferris, {Daron Gale} and Koutsky, {Laura A.} and Kurman, {Robert J.} and Myers, {Evan R.} and Eliav Barr and John Boslego and Janine Bryan and Esser, {Mark T.} and Hesley, {Teresa M.} and Micki Nelson and Radha Railkar and Margaret James and Carlos Sattler and Taddeo, {Frank J.} and Thornton, {Annemarie R.} and Vuocolo, {Scott C.}",
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T1 - Prophylactic efficacy of a quadrivalent human papillomavirus (HPV) vaccine in women with virological evidence of HPV Infection

AU - Villa, Luisa L.

AU - Perez, Gonzalo

AU - Kjær, Susanne Krüger

AU - Paavonen, Jorma

AU - Lehtinen, Matti

AU - Muñoz, Nubia

AU - Sigurdsson, Kristján

AU - Hernandez-Avila, Mauricio

AU - Iversen, Ole Eric

AU - Thoresen, Steinar

AU - García, Patricia J.

AU - Majewski, Slawomir

AU - Eng, Hseon Tay

AU - Bosch, F. Xavier

AU - Dillner, Joakim

AU - Olsson, Sven Eric

AU - Ault, Kevin A.

AU - Brown, Darron R.

AU - Ferris, Daron Gale

AU - Koutsky, Laura A.

AU - Kurman, Robert J.

AU - Myers, Evan R.

AU - Barr, Eliav

AU - Boslego, John

AU - Bryan, Janine

AU - Esser, Mark T.

AU - Hesley, Teresa M.

AU - Nelson, Micki

AU - Railkar, Radha

AU - James, Margaret

AU - Sattler, Carlos

AU - Taddeo, Frank J.

AU - Thornton, Annemarie R.

AU - Vuocolo, Scott C.

PY - 2007/11/15

Y1 - 2007/11/15

N2 - Background. A quadrivalent (types 6, 11, 16, and 18) human papillomavirus (HPV) L1 virus-like-particle (VLP) vaccine has been shown to be 95%-100% effective in preventing cervical and genital disease related to HPV-6, -11, -16, and -18 in 16-26-year-old women naive for HPV vaccine types. Because most women in the general population are sexually active, some will have already been infected with ≥1 HPV vaccine types at the time vaccination is offered. Here, we assessed whether such infected women are protected against disease caused by the remaining HPV vaccine types. Methods. Two randomized, placebo-controlled trials of the quadrivalent (types 6, 11, 16, and 18) HPV vaccine enrolled 17,622 women without consideration of baseline HPV status. Among women infected with 1-3 HPV vaccine types at enrollment, efficacy against genital disease related to the HPV vaccine type or types for which subjects were naive was assessed. Results. Vaccination was 100% effective (95% confidence interval [CI], 79%-100%) in preventing incident cervical intraepithelial neoplasia 2 or 3 or cervical adenocarcinoma in situ caused by the HPV type or types for which the women were negative at enrollment. Efficacy for preventing vulvar or vaginal HPV-related lesions was 94% (95% CI, 81%-99%). Conclusions. Among women positive for 1-3 HPV vaccine types before vaccination, the quadrivalent HPV vaccine protected against neoplasia caused by the remaining types. These results support vaccination of the general population without prescreening.

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