Nine-valent HPV vaccine efficacy against related diseases and definitive therapy: comparison with historic placebo population

Gynecologic Oncology - Tập 154 Số 1 - Trang 110-117 - 2019
Anna R. Giuliano1, Elmar A. Joura2, Suzanne M. Garland3,4,5, Warner K. Huh6, Ole-Erik Iversen7,8, Susanne K. Kjær9,10, Alex Ferenczy11, Robert J. Kurman12,13, Brigitte M. Ronnett12,13, Mark H. Stoler14, Oliver Bautista15, Erin Moeller15, Michael Ritter15, Christine Shields15, Alain Luxembourg15
1Center for Infection Research in Cancer, Moffitt Cancer Center, Tampa, FL, United States
2Department of Obstetrics and Gynecology, Comprehensive Cancer Center, Medical University of Vienna, Vienna, Austria
3Centre for Women's Infectious Diseases Research, The Royal Women's Hospital, Parkville, Victoria, Australia
4Department of Obstetrics and Gynaecology, The University of Melbourne, Victoria, Australia
5Infection and Immunity, Murdoch Children's Research Institute, Victoria, Australia
6Division of Gynecologic Oncology, University of Alabama at Birmingham, Birmingham, AL, United States
7Department of Clinical Science, University of Bergen, Bergen, Norway
8Department of Gynecology and Obstetrics, Haukeland University Hospital, Bergen, Norway
9Department of Gynecology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark
10Unit of Virus, Lifestyle and Genes, Danish Cancer Society, Copenhagen, Denmark
11Department of Pathology, McGill University Health Center and Jewish General Hospital, Montreal, QC, Canada
12Department of Gynecology and Obstetrics, The Johns Hopkins University School of Medicine, Baltimore, MD, United States
13Department of Pathology, The Johns Hopkins University School of Medicine, Baltimore, MD, United States
14Department of Pathology, University of Virginia Health System, Charlottesville, VA, United States
15Merck & Co., Inc., Kenilworth, NJ, United States

Tóm tắt

Từ khóa


Tài liệu tham khảo

de Sanjose, 2010, Human papillomavirus genotype attribution in invasive cervical cancer: a retrospective cross-sectional worldwide study, Lancet Oncol., 11, 1048, 10.1016/S1470-2045(10)70230-8

Alemany, 2015, Human papillomavirus DNA prevalence and type distribution in anal carcinomas worldwide, Int. J. Cancer, 136, 98, 10.1002/ijc.28963

Garland, 2009, Natural history of genital warts: analysis of the placebo arm of 2 randomized phase III trials of a quadrivalent human papillomavirus (types 6, 11, 16, and 18) vaccine, J. Infect. Dis., 199, 805, 10.1086/597071

Joura, 2014, Attribution of 12 high-risk human papillomavirus genotypes to infection and cervical disease, Cancer Epidemiol. Biomark. Prev., 23, 1997, 10.1158/1055-9965.EPI-14-0410

Serrano, 2015, Human papillomavirus genotype attribution for HPVs 6, 11, 16, 18, 31, 33, 45, 52 and 58 in female anogenital lesions, Eur. J. Cancer, 51, 1732, 10.1016/j.ejca.2015.06.001

Pitisuttithum, 2015, 9-valent HPV vaccine for cancers, pre-cancers and genital warts related to HPV, Expert Rev. Vaccines, 14, 1405, 10.1586/14760584.2015.1089174

Joura, 2015, A 9-valent HPV vaccine against infection and intraepithelial neoplasia in women, N. Engl. J. Med., 372, 711, 10.1056/NEJMoa1405044

Huh, 2017, Final efficacy, immunogenicity, and safety analyses of a nine-valent human papillomavirus vaccine in women aged 16-26 years: a randomised, double-blind trial, Lancet, 390, 2143, 10.1016/S0140-6736(17)31821-4

Luxembourg, 2015, Design of a large outcome trial for a multivalent human papillomavirus L1 virus-like particle vaccine, Contemp. Clin. Trials, 42, 18, 10.1016/j.cct.2015.02.009

FUTURE II Study Group, 2007, Quadrivalent vaccine against human papillomavirus to prevent high-grade cervical lesions, N. Engl. J. Med., 356, 1915, 10.1056/NEJMoa061741

Garland, 2007, Quadrivalent vaccine against human papillomavirus to prevent anogenital diseases, N. Engl. J. Med., 356, 1928, 10.1056/NEJMoa061760

Chen, 2015, A seamless phase IIB/III adaptive outcome trial: design rationale and implementation challenges, Clin. Trials, 12, 84, 10.1177/1740774514552110

Else, 2011, Comparison of real-time multiplex human papillomavirus (HPV) PCR assays with INNO-LiPA HPV genotyping extra assay, J. Clin. Microbiol., 49, 1907, 10.1128/JCM.00236-10

Roberts, 2011, Comparison of real-time multiplex human papillomavirus (HPV) PCR assays with the linear array HPV genotyping PCR assay and influence of DNA extraction method on HPV detection, J. Clin. Microbiol., 49, 1899, 10.1128/JCM.00235-10

Bouvard, 2009, A review of human carcinogens--part B: biological agents, Lancet Oncol., 10, 321, 10.1016/S1470-2045(09)70096-8

Munoz, 2010, Impact of human papillomavirus (HPV)-6/11/16/18 vaccine on all HPV-associated genital diseases in young women, J. Natl. Cancer Inst., 102, 325, 10.1093/jnci/djp534

Luxembourg, 2017, 9-valent human papillomavirus vaccine: a review of the clinical development program, Expert Rev. Vaccines, 16, 1119, 10.1080/14760584.2017.1383158

Joura, 2007, Efficacy of a quadrivalent prophylactic human papillomavirus (types 6, 11, 16, and 18) L1 virus-like-particle vaccine against high-grade vulval and vaginal lesions: a combined analysis of three randomised clinical trials, Lancet, 369, 1693, 10.1016/S0140-6736(07)60777-6

Haupt, 2011, Impact of an HPV6/11/16/18 L1 virus-like particle vaccine on progression to cervical intraepithelial neoplasia in seropositive women with HPV16/18 infection, Int. J. Cancer, 129, 2632, 10.1002/ijc.25940

Munoz, 2009, Jr., P. Pitisuttithum, D. Tresukosol, J. Monsonego, K. Ault, et al. Safety, immunogenicity, and efficacy of quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine in women aged 24-45 years: a randomised, double-blind trial, Lancet, 373, 1949, 10.1016/S0140-6736(09)60691-7

FUTURE II Study Group, 2007, Prophylactic efficacy of a quadrivalent human papillomavirus (HPV) vaccine in women with virological evidence of HPV infection, J. Infect. Dis., 196, 1438, 10.1086/522864

Joura, 2012, Effect of the human papillomavirus (HPV) quadrivalent vaccine in a subgroup of women with cervical and vulvar disease: retrospective pooled analysis of trial data, BMJ, 344, e1401, 10.1136/bmj.e1401

Swedish, 2012, Prevention of recurrent high-grade anal neoplasia with quadrivalent human papillomavirus vaccination of men who have sex with men: a nonconcurrent cohort study, Clin. Infect. Dis., 54, 891, 10.1093/cid/cir1036

Garland, 2016, Prior human papillomavirus-16/18 AS04-adjuvanted vaccination prevents recurrent high grade cervical intraepithelial neoplasia after definitive surgical therapy: post-hoc analysis from a randomized controlled trial, Int. J. Cancer, 139, 2812, 10.1002/ijc.30391

Kang, 2013, Is vaccination with quadrivalent HPV vaccine after loop electrosurgical excision procedure effective in preventing recurrence in patients with high-grade cervical intraepithelial neoplasia (CIN2-3)?, Gynecol. Oncol., 130, 264, 10.1016/j.ygyno.2013.04.050

Monsonego, 2015, Prevalence of high-risk human papilloma virus genotypes and associated risk of cervical precancerous lesions in a large U.S. screening population: data from the ATHENA trial, Gynecol. Oncol., 137, 47, 10.1016/j.ygyno.2015.01.551

Saraiya, 2015, US assessment of HPV types in cancers: implications for current and 9-valent HPV vaccines, J. Natl. Cancer Inst., 107, 10.1093/jnci/djv086

Giorgi Rossi, 2017, Cervical cancer screening in women vaccinated against human papillomavirus infection: recommendations from a consensus conference, Prev. Med., 98, 21, 10.1016/j.ypmed.2016.11.020

Schiffman, 2015, A study of genotyping for management of human papillomavirus-positive, cytology-negative cervical screening results, J. Clin. Microbiol., 53, 52, 10.1128/JCM.02116-14

Thông tin
Thông tin xuất bản

Gynecologic Oncology

Tập 154 Số 1

110-117

Thông tin tác giả