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

被引：430

作者：

Brown, Darron R. ^{[1
]}

Kjaer, Susanne K. ^{[2
]}

Sigurdsson, Kristjan ^{[3
]}

Iversen, Ole-Erik ^{[4
,5
]}

Hernandez-Avila, Mauricio ^{[6
]}

Wheeler, Cosette M. ^{[7
,8
]}

Perez, Gonzalo ^{[9
]}

Koutsky, Laura A. ^{[10
]}

Tay, Eng Hseon ^{[11
]}

Garcia, Patricia ^{[12
]}

Ault, Kevin A. ^{[13
]}

Garland, Suzanne M. ^{[14
,15
]}

Leodolter, Sepp ^{[16
]}

Olsson, Sven-Eric ^{[17
]}

Tang, Grace W. K. ^{[18
]}

Ferris, Daron G. ^{[19
]}

Paavonen, Jorma ^{[20
]}

Steben, Marc ^{[21
]}

Bosch, F. Xavier ^{[22
]}

Dillner, Joakim ^{[23
]}

Joura, Elmar A. ^{[16
]}

Kurman, Robert J. ^{[24
,25
]}

Majewski, Slawomir ^{[26
]}

Munoz, Nubia ^{[27
]}

Myers, Evan R. ^{[28
]}

Villa, Luisa L. ^{[29
]}

Taddeo, Frank J. ^{[30
]}

Roberts, Christine ^{[30
]}

Tadesse, Amha ^{[30
]}

Bryan, Janine ^{[30
]}

Lupinacci, Lisa C. ^{[30
]}

Giacoletti, Katherine E. D. ^{[30
]}

Sings, Heather L. ^{[30
]}

James, Margaret ^{[30
]}

Hesley, Teresa M. ^{[30
]}

Barra, Eliav ^{[30
]}

机构：

[1] Indiana Univ, Sch Med, Indianapolis, IN 46202 USA

[2] Rigshosp, Danish Canc Soc, Dept Virus Hormones & Canc, Inst Canc Epidemiol, DK-2100 Copenhagen, Denmark

[3] Natl Canc Detect Clin, Reykjavik, Iceland

[4] Univ Bergen, Dept Clin Med, Bergen, Norway

[5] Haukeland Hosp, Dept Obstet & Gynecol, N-5021 Bergen, Norway

[6] Inst Publ Hlth, Cuernavaca, Morelos, Mexico

[7] Univ New Mexico, Dept Mol Genet & Microbiol, Albuquerque, NM 87131 USA

[8] Univ New Mexico, Dept Obstet & Gynecol, Albuquerque, NM 87131 USA

[9] Univ Rosario, Bogota, Colombia

[10] Univ Washington, Dept Epidemiol, Seattle, WA 98195 USA

[11] KK Womens & Childrens Hosp, Singapore, Singapore

[12] Univ Peruana Cayetano Heredia, Epidemiol HIV & STD Unit, Lima, Peru

[13] Emory Univ, Sch Med, Dept Gynecol & Obstet, Atlanta, GA 30322 USA

[14] Univ Melbourne, Microbiol & Infect Dis Dept, Royal Womens Hosp, Melbourne, Vic, Australia

[15] Univ Melbourne, Dept Obstet & Gynecol, Melbourne, Vic, Australia

[16] Med Univ Vienna, Dept Gynecol & Obstet, Vienna, Austria

[17] Karolinska Inst, Danderyd Hosp, Stockholm, Sweden

[18] Univ Hong Kong, Dept Obstet & Gynecol, Hong Kong, Hong Kong, Peoples R China

[19] Med Coll Georgia, Dept Family Med & Obstet & Gynecol, Augusta, GA 30912 USA

[20] Univ Cent Hosp, Dept Obstet & Gynecol, Helsinki, Finland

[21] Inst Natl Sante Publ Quebec, Direct Risques Biol Environm & Occupat, Montreal, PQ, Canada

[22] IDIBELL, Inst Catala Oncol, Barcelona, Spain

[23] Lund Univ, Dept Med Microbiol, Lund, Sweden

[24] Johns Hopkins Univ, Sch Med, Dept Gynecol & Obstet, Baltimore, MD USA

[25] Johns Hopkins Univ, Sch Med, Dept Pathol & Oncol, Baltimore, MD USA

[26] Warsaw Med Univ, Dept Dermatol & Venereol, Ctr Diagnost & Treatment Sexually Transmitted Dis, Warsaw, Poland

[27] Natl Canc Inst, Bogota, Colombia

[28] Duke Univ, Med Ctr, Dept Obstet & Gynecol, Durham, NC USA

[29] Ludwig Inst Canc Res, Dept Virol, Sao Paulo, Brazil

[30] Merck Res Labs, West Point, PA USA

来源：

JOURNAL OF INFECTIOUS DISEASES | 2009年 / 199卷 / 07期

关键词：

GRADE CERVICAL LESIONS; DOUBLE-BLIND; YOUNG-WOMEN; EFFICACY; CANCER; CLASSIFICATION;

D O I：

10.1086/597307

中图分类号：

R392 [医学免疫学]; Q939.91 [免疫学];

学科分类号：

100102 ;

摘要：

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 similar to 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.

引用

页码：926 / 935

页数：10

共 27 条

[11] Epidemiologic classification of human papillomavirus types associated with cervical cancer [J].

Muñoz, N ;

Bosch, FX ;

de Sanjosé, S ;

Herrero, R ;

Castellsagué, X ;

Shah, KV ;

Snijders, PJF ;

Meijer, CJLM .

NEW ENGLAND JOURNAL OF MEDICINE, 2003, 348 (06) :518-527

[12]

National Cancer Institute, CANC ADV FOC CERV CA

[13] Induction of immune memory following administration of a prophylactic quadrivalent human papillomavirus (HPV) types 6/11/16/18 L1 virus-like particle (VLP) vaccine [J].

Olsson, Sven-Eric ;

Villa, Luisa L. ;

Costa, Ronaldo L. R. ;

Petta, Carlos A. ;

Andrade, Rosires P. ;

Malm, Christian ;

Iversen, Ole-Erik ;

Hoye, John ;

Steinwall, Margareta ;

Riis-Johannessen, Grete ;

Andersson-Ellstrom, Agneta ;

Elfgren, Kristina ;

von Krogh, Geo ;

Lehtinen, Matti ;

Paavonen, Jorma ;

Tamms, Gretchen M. ;

Giacoletti, Katherine ;

Lupinacci, Lisa ;

Esser, Mark T. ;

Vuocolo, Scott C. ;

Saah, Alfred J. ;

Barr, Eliav .

VACCINE, 2007, 25 (26) :4931-4939

[14] Efficacy of a prophylactic adjuvanted bivalent L1 virus-like-particle vaccine against infection with human papillomavirus types 16 and 18 in young women:: an interim analysis of a phase III double-blind, randomised controlled trial [J].

Paavonen, Jorma ;

Jenkins, David ;

Bosch, F. Xavier ;

Naud, Paulo ;

Salmeron, Jorge ;

Wheeler, Cosette M. ;

Chow, Song-Nan ;

Apter, Dan L. ;

Kitchener, Henry C. ;

Castellsague, Xavier ;

de Carvalho, Newton S. ;

Skinner, S. Rachel ;

Harper, Diane M. ;

Hedrick, James A. ;

Jaisamrarn, Unnop ;

Limson, Genara A. M. ;

Dionne, Marc ;

Quint, Wim ;

Spiessens, Bart ;

Peeters, Pascal ;

Struyf, Frank ;

Wieting, Susan L. ;

Lehtinen, Matti O. ;

Dubin, Gary .

LANCET, 2007, 369 (9580) :2161-2170

[15] American Cancer Society guideline for human papillornavirus (HPV) vaccine use to prevent cervical cancer and its precursors [J].

Saslow, Debbie ;

Castle, Philip E. ;

Cox, J. Thomas ;

Davey, Diane D. ;

Einstein, Mark H. ;

Ferris, Daron G. ;

Goldie, Sue J. ;

Harper, Diane M. ;

Kinney, Walter ;

Moscicki, Anna-Barbara ;

Noller, Kenneth L. ;

Wheeler, Cosette M. ;

Ades, Terri ;

Andrews, Kimberly S. ;

Doroshenk, Mary K. ;

Green Kahn, Kelly ;

Schmidt, Christy ;

Shafey, Omar ;

Smith, Robert A. ;

Partridge, Edward E. .

CA-A CANCER JOURNAL FOR CLINICIANS, 2007, 57 (01) :7-28

[16] Human papillomavirus type distribution in invasive cervical cancer and high-grade cervical lesions: A meta-analysis update [J].

Smith, Jennifer S. ;

Lindsay, Lisa ;

Hoots, Brooke ;

Keys, Jessica ;

Franceschi, Silvia ;

Winer, Rachel ;

Clifford, Gary M. .

INTERNATIONAL JOURNAL OF CANCER, 2007, 121 (03) :621-632

[17] Effect of prophylactic human papillomavirus L1 virus-like-particle vaccine on risk of cervical intraepithelial neoplasia grade 2, grade 3, and adenocarcinoma in situ:: a combined analysis of four randomised clinical trials [J].

Villa, L. ;

Perez, G. ;

Kjaer, S. ;

Lehtinen, M. ;

Paavonen, J. ;

Munoz, N. ;

Sigurdsson, K. ;

Hernandez-Avila, M. ;

Iversen, O. E. ;

Thoresen, S. ;

Garcia, P. ;

Majewski, S. ;

Tay, E. H. ;

Bosch, F. X. ;

Dillner, J. ;

Olsson, S. E. ;

Ault, K. ;

Brown, D. ;

Ferris, D. ;

Giuliano, A. ;

Koutsky, L. ;

Kurman, R. ;

Myers, E. ;

Barr, E. ;

Boslego, J. ;

Bryan, J. ;

Esser, M. ;

Hesley, T. ;

Lupinacci, L. ;

Railkar, R. ;

Sings, H. ;

Taddeo, F. ;

Thornton, A. .

LANCET, 2007, 369 (9576) :1861-1868

[18] Prophylactic quadrivalent human papillomavirus (types 6, 11, 16, and 18) L1 virus-like particle vaccine in young women: a randomised double-blind placebo-controlled multicentre phase II efficacy trial [J].

Villa, LL ;

Costa, RLR ;

Petta, CA ;

Andrade, RP ;

Ault, KA ;

Giuliano, AR ;

Wheeler, CM ;

Koutsky, LA ;

Malm, C ;

Lehtinen, M ;

Skjeldestad, FE ;

Olsson, SE ;

Steinwall, M ;

Brown, DR ;

Kurman, R ;

Ronnett, BM ;

Stoler, MH ;

Ferenczy, A ;

Harper, DM ;

Tamms, GM ;

Yu, J ;

Lupinacci, L ;

Railkar, R ;

Taddeo, FJ ;

Jansen, KU ;

Esser, MT ;

Sings, HL ;

Saah, AJ ;

Lupinacci, L .

LANCET ONCOLOGY, 2005, 6 (05) :271-278

[19] Prophylactic efficacy of a quadrivalent human papillomavirus (HPV) vaccine in women with virological evidence of HPV infection [J].

Villa, Luisa L. ;

Perez, Gonzalo ;

Kjaer, Susanne Krueger ;

Paavonen, Jorma ;

Lehtinen, Matti ;

Munoz, Nubia ;

Sigurdsson, Kristjan ;

Hernandez-Avila, Mauricio ;

Iversen, Ole Eric ;

Thoresen, Steinar ;

Garcia, Patricia J. ;

Majewski, Slawomir ;

Tay, Eng Hseon ;

Bosch, F. Xavier ;

Dillner, Joakim ;

Olsson, Sven-Eric ;

Ault, Kevin A. ;

Brown, Darron R. ;

Ferris, Daron G. ;

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. .

JOURNAL OF INFECTIOUS DISEASES, 2007, 196 (10) :1438-1446

[20]

Villa LL, 2007, NEW ENGL J MED, V356, P1915, DOI 10.1056/NEJMoa061741

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