Please use this identifier to cite or link to this item: https://www.arca.fiocruz.br/handle/icict/13256
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dc.contributor.authorJoura, E. A.
dc.contributor.authorGiuliano, Anna R.
dc.contributor.authorIversen, O. E.
dc.contributor.authorBouchard, C.
dc.contributor.authorMao, C.
dc.contributor.authorMehlsen, J.
dc.contributor.authorMoreira Júnior, Edson Duarte
dc.contributor.authorNgan, Y.
dc.contributor.authorPetersen, L. K.
dc.contributor.authorLazcano‑Ponce, E.
dc.contributor.authorPitisuttithum, P.
dc.contributor.authorRestrepo, J. A.
dc.contributor.authorStuart, G.
dc.contributor.authorWoelber, L.
dc.contributor.authorYang, Y. C.
dc.contributor.authorCuzick, J.
dc.contributor.authorGarland, S. M.
dc.contributor.authorHuh, W.
dc.contributor.authorKjaer, S. K.
dc.contributor.authorBautista, Oliver M.
dc.contributor.authorChan, I. S. F.
dc.contributor.authorChen, J.
dc.contributor.authorGesser, R.
dc.contributor.authorMoeller, E.
dc.contributor.authorRitter, M.
dc.contributor.authorVuocolo, S.
dc.contributor.authorLuxembourg, A.
dc.contributor.authorBroad Spectrum HPV Vaccine Study
dc.date.accessioned2016-03-23T18:18:32Z
dc.date.available2016-03-23T18:18:32Z
dc.date.issued2015
dc.identifier.citationJOURA, E. A. et al. A 9-valent HPV vaccine against infection and intraepithelial neoplasia in women. New England Journal of Medicine, v. 372, n. 8, p. 711-723, 2015.
dc.identifier.issn1533-4406
dc.identifier.urihttps://www.arca.fiocruz.br/handle/icict/13256
dc.language.isoeng
dc.publisherMassachusetts Medical Society
dc.rightsopen access
dc.titleA 9-valent HPV vaccine against infection and intraepithelial neoplasia in women
dc.typeArticle
dc.identifier.doi10.1056/NEJMoa1405044
dc.description.abstractenBACKGROUND: 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. METHODS: We performed a randomized, international, double-blind, phase 2b-3 study of the 9vHPV vaccine in 14,215 women. Participants received the 9vHPV vaccine or the qHPV vaccine in a series of three intramuscular injections on day 1 and at months 2 and 6. Serum was collected for analysis of antibody responses. Swabs of labial, vulvar, perineal, perianal, endocervical, and ectocervical tissue were obtained and used for HPV DNA testing, and liquid-based cytologic testing (Papanicolaou testing) was performed regularly. Tissue obtained by means of biopsy or as part of definitive therapy (including a loop electrosurgical excision procedure and conization) was tested for HPV. RESULTS: The rate of high-grade cervical, vulvar, or vaginal disease irrespective of HPV type (i.e., disease caused by HPV types included in the 9vHPV vaccine and those not included) in the modified intention-to-treat population (which included participants with and those without prevalent infection or disease) was 14.0 per 1000 person-years in both vaccine groups. The rate of high-grade cervical, vulvar, or vaginal disease related to HPV-31, 33, 45, 52, and 58 in a prespecified per-protocol efficacy population (susceptible population) was 0.1 per 1000 person-years in the 9vHPV group and 1.6 per 1000 person-years in the qHPV group (efficacy of the 9vHPV vaccine, 96.7%; 95% confidence interval, 80.9 to 99.8). Antibody responses to HPV-6, 11, 16, and 18 were noninferior to those generated by the qHPV vaccine. Adverse events related to injection site were more common in the 9vHPV group than in the qHPV group. CONCLUSIONS: The 9vHPV vaccine prevented infection and disease related to HPV-31, 33, 45, 52, and 58 in a susceptible population and generated an antibody response to HPV-6, 11, 16, and 18 that was noninferior to that generated by the qHPV vaccine. The 9vHPV vaccine did not prevent infection and disease related to HPV types beyond the nine types covered by the vaccine.
dc.creator.affilliationThe Medical University of Vienna. Comprehensive Cancer Center. Vienna.
dc.creator.affilliationMoffitt Cancer Center. Tampa, Florida, USA.
dc.creator.affilliationUniversity of Bergen–Haukeland University Hospital. Department of Clinical Medicine. Bergen, Norway.
dc.creator.affilliationUniversité Laval. Québec, Canadá.
dc.creator.affilliationUniversity of Washington. Seattle, USA.
dc.creator.affilliationUniversity of Copenhagen. Coordinating Research Center. Frederiksberg Hospital. Copenhagen.
dc.creator.affilliationAssociação Obras Sociais Irmã Dulce. Salvador, BA, Brasil / Fundação Oswaldo Cruz. Centro de Pesquisas Gonçalo Moniz. Salvador, BA, Brasil.
dc.creator.affilliationUniversity of Hong Kong. Hong Kong.
dc.creator.affilliationAarhus University Hospital. Department of Obstetrics and Gynecology. Aarhus, Denmark.
dc.creator.affilliationInstituto Nacional de Salud Pública. Cuernavaca, Morelos, Mexico.
dc.creator.affilliationMahidol University. Faculty of Tropical Medicine. Nakhon Pathom, Thailand.
dc.creator.affilliationInvestigación Clínica. Medellín, Colombia.
dc.creator.affilliationUniversity of British Columbia. Vancouver, Canada.
dc.creator.affilliationUniversity Medical Center Hamburg–Eppendorf. Department of Gynecology. Hamburg, Germany.
dc.creator.affilliationMackay Memorial Hospital. Taipei, Taiwan.
dc.creator.affilliationWolfson Institute of Preventive Medicine. London.
dc.creator.affilliationRoyal Women’s Hospital. University of Melbourne and Murdoch Childrens Research Institute. Parkville, VIC, Australia.
dc.creator.affilliationUniversity of Alabama. Division of Gynecologic Oncology. Birmingham.
dc.creator.affilliationDanish Cancer Society Research Center and Department of Gynecology. Rigshospitalet, Copenhagen.
dc.creator.affilliationUniversity of Alabama. Division of Gynecologic Oncology. Birmingham / Merck, Whitehouse Station, NJ, USA.
dc.creator.affilliationUniversity of Alabama. Division of Gynecologic Oncology. Birmingham / Merck, Whitehouse Station, NJ, USA.
dc.creator.affilliationUniversity of Alabama. Division of Gynecologic Oncology. Birmingham / Merck, Whitehouse Station, NJ, USA.
dc.creator.affilliationUniversity of Alabama. Division of Gynecologic Oncology. Birmingham / Merck, Whitehouse Station, NJ, USA.
dc.creator.affilliationUniversity of Alabama. Division of Gynecologic Oncology. Birmingham / Merck, Whitehouse Station, NJ, USA.
dc.creator.affilliationUniversity of Alabama. Division of Gynecologic Oncology. Birmingham / Merck, Whitehouse Station, NJ, USA.
dc.creator.affilliationUniversity of Alabama. Division of Gynecologic Oncology. Birmingham / Merck, Whitehouse Station, NJ
dc.creator.affilliationUniversity of Alabama. Division of Gynecologic Oncology. Birmingham / Merck, Whitehouse Station, NJ, USA.
dc.creator.affilliationBroad Spectrum HPV Vaccine Study.
dc.subject.en9-Valent HPV Vaccine
dc.subject.enInfection Neoplasia
dc.subject.enIntraepithelial Neoplasia
dc.subject.enWomen
dc.subject.decsAlphapapillomavirus
dc.subject.decsNeoplasia Intraepitelial Cervical/prevenção & controle
dc.subject.decsInfecções por Papillomavirus/prevenção & controle
dc.subject.decsVacinas contra Papillomavirus
dc.subject.decsNeoplasias do Colo do Útero/prevenção & controle
dc.subject.decsAdolescente
dc.subject.decsAdulto
dc.subject.decsAnticorpos Antivirais/sangue
dc.subject.decsNeoplasia Intraepitelial Cervical/virologia
dc.subject.decsMétodo Duplo-Cego
dc.subject.decsFeminino
dc.subject.decsDoenças dos Genitais Femininos/epidemiologia
dc.subject.decsHumanos
dc.subject.decsIncidência
dc.subject.decsAnálise de Intenção de Tratamento
dc.subject.decsInfecções por Papillomavirus/epidemiologia
dc.subject.decsVacinas contra Papillomavirus/administração & dosagem
dc.subject.decsNeoplasias do Colo do Útero/virologia
Appears in Collections:BA - IGM - Artigos de Periódicos

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