A 9-valent HPV vaccine against infection and intraepithelial neoplasia in women.

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Abstract

The investigational 9-valent viruslike particle vaccine against human papillomavirus (HPV) includes the HPV types in the quadrivalent HPV (qHPV) vaccine (6, 11, 16, and 18) and five additional oncogenic types (31, 33, 45, 52, and 58). Here we present the results of a study of the efficacy and immunogenicity of the 9vHPV vaccine in women 16 to 26 years of age.

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Most cited references 35

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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

Jorma Paavonen, David Jenkins, F Bosch … (2007)

The Lancet, 369(9580), 2161-2170

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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.

Darron R Brown, Susanne Kjaer, Kristján Sigurdsson … (2009)

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. 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 genotyping 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. 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. HPV-6/11/16/18 vaccine reduced the risk of CIN2-3/AIS associated with nonvaccine types responsible for approximately 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. ClinicalTrials.gov identifiers: NCT00092521 , NCT00092534 , and NCT00092482.

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Reduction in human papillomavirus (HPV) prevalence among young women following HPV vaccine introduction in the United States, National Health and Nutrition Examination Surveys, 2003-2010.

Ronald Unger, E Dunne, Carol Lin … (2013)

Human papillomavirus (HPV) vaccination was introduced into the routine immunization schedule in the United States in late 2006 for females aged 11 or 12 years, with catch-up vaccination recommended for those aged 13-26 years. In 2010, 3-dose vaccine coverage was only 32% among 13-17 year-olds. Reduction in the prevalence of HPV types targeted by the quadrivalent vaccine (HPV-6, -11, -16, and -18) will be one of the first measures of vaccine impact. We analyzed HPV prevalence data from the vaccine era (2007-2010) and the prevaccine era (2003-2006) that were collected during National Health and Nutrition Examination Surveys. HPV prevalence was determined by the Linear Array HPV Assay in cervicovaginal swab samples from females aged 14-59 years; 4150 provided samples in 2003-2006, and 4253 provided samples in 2007-2010. Among females aged 14-19 years, the vaccine-type HPV prevalence (HPV-6, -11, -16, or -18) decreased from 11.5% (95% confidence interval [CI], 9.2-14.4) in 2003-2006 to 5.1% (95% CI, 3.8-6.6) in 2007-2010, a decline of 56% (95% CI, 38-69). Among other age groups, the prevalence did not differ significantly between the 2 time periods (P > .05). The vaccine effectiveness of at least 1 dose was 82% (95% CI, 53-93). Within 4 years of vaccine introduction, the vaccine-type HPV prevalence decreased among females aged 14-19 years despite low vaccine uptake. The estimated vaccine effectiveness was high.

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Author and article information

Journal

Journal ID (iso-abbrev): N. Engl. J. Med.

Title: The New England journal of medicine

ISSN (Electronic): 1533-4406

ISSN (Print): 0028-4793

Publication date (Electronic): Feb 19 2015

Volume: 372

Issue: 8

Affiliations

[1 ] From the Medical University of Vienna, Comprehensive Cancer Center, Vienna (E.A.J.); Moffitt Cancer Center, Tampa, FL (A.R.G.); Department of Clinical Medicine, University of Bergen-Haukeland University Hospital, Bergen, Norway (O.-E.I.); Université Laval, Québec, QC (C.B.), and University of British Columbia, Vancouver (G.S.) - both in Canada; University of Washington, Seattle (C.M.); Coordinating Research Center, Frederiksberg Hospital, University of Copenhagen (J.M.), and Danish Cancer Society Research Center and Department of Gynecology, Rigshospitalet (S.K.K.) - all in Copenhagen; Associação Obras Sociais Irmã Dulce and Oswaldo Cruz Foundation, Brazilian Ministry of Health, Bahia, Brazil (E.D.M.); University of Hong Kong, Hong Kong (Y.N.); Aarhus University Hospital, Department of Obstetrics and Gynecology, Aarhus, Denmark (L.K.P.); Instituto Nacional de Salud Pública, Cuernavaca, Morelos, Mexico (E.L.-P.); Faculty of Tropical Medicine, Mahidol University, Nakhon Pathom, Thailand (P.P.); Investigación Clínica, Medellín, Colombia (J.A.R.); Department of Gynecology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany (L.W.); Mackay Memorial Hospital, Taipei, Taiwan (Y.C.Y.); Wolfson Institute of Preventive Medicine, London (J. Cuzick); Royal Women's Hospital, University of Melbourne and Murdoch Childrens Research Institute, Parkville, VIC, Australia (S.M.G.); Division of Gynecologic Oncology, University of Alabama, Birmingham (W.H.); and Merck, Whitehouse Station, NJ (O.M.B., I.S.F.C., J. Chen, R.G., E.M., M.R., S.V., A.L.).

Article

DOI: 10.1056/NEJMoa1405044

PubMed ID: 25693011

SO-VID: 4a7db3f3-59e1-4cff-9e64-0d6dc6a98a28

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