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:429
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
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.
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收藏
页码:926 / 935
页数:10
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