Please use this identifier to cite or link to this item: https://www.arca.fiocruz.br/handle/icict/13256
Title: A 9-valent HPV vaccine against infection and intraepithelial neoplasia in women.
Authors: Joura, E.A
Giuliano, Anna R
Iversen, O.-E
Bouchard, C
Mao, C
Mehlsen, J
Moreira Júnior, Edson Duarte
Ngan, Y
Petersen, L.K
Lazcano‑Ponce, E
Pitisuttithum, P
Restrepo, J.A
Stuart, G
Woelber, L
Yang, Y.C
Cuzick, J
Garland, S.M
Huh, W
Kjaer, S.K
Bautista, O.M
Chan, I.S.F
Chen, J
Gesser, R
Moeller, E
Ritter, M
Vuocolo, S
Luxembourg, A
Broad Spectrum HPV Vaccine Study
Affilliation: The Medical University of Vienna. Comprehensive Cancer Center. Vienna
Moffitt Cancer Center. Tampa, Florida
University of Bergen–Haukeland University Hospital. Department of Clinical Medicine. Bergen, Norway
Université Laval. Québec, Canadá
University of Washington. Seattle
University of Copenhagen. Coordinating Research Center. Frederiksberg Hospital. Copenhagen
Associação Obras Sociais Irmã Dulce. Salvador, BA, Brasil / Fundação Oswaldo Cruz. Centro de Pesquisas Gonçalo Moniz. Salvador, BA, Brasil
University of Hong Kong. Hong Kong
Aarhus University Hospital. Department of Obstetrics and Gynecology. Aarhus, Denmark
Instituto Nacional de Salud Pública. Cuernavaca, Morelos, Mexico
Mahidol University. Faculty of Tropical Medicine. Nakhon Pathom, Thailand
Investigación Clínica. Medellín, Colombia
University of British Columbia. Vancouver, Canada
University Medical Center Hamburg–Eppendorf. Department of Gynecology. Hamburg, Germany
Mackay Memorial Hospital. Taipei, Taiwan
Wolfson Institute of Preventive Medicine. London
Royal Women’s Hospital. University of Melbourne and Murdoch Childrens Research Institute. Parkville, VIC, Australia
University of Alabama. Division of Gynecologic Oncology. Birmingham
Danish Cancer Society Research Center and Department of Gynecology. Rigshospitalet, Copenhagen;
University of Alabama. Division of Gynecologic Oncology. Birmingham / Merck, Whitehouse Station, NJ
University of Alabama. Division of Gynecologic Oncology. Birmingham / Merck, Whitehouse Station, NJ
University of Alabama. Division of Gynecologic Oncology. Birmingham / Merck, Whitehouse Station, NJ
University of Alabama. Division of Gynecologic Oncology. Birmingham / Merck, Whitehouse Station, NJ
University of Alabama. Division of Gynecologic Oncology. Birmingham / Merck, Whitehouse Station, NJ
University of Alabama. Division of Gynecologic Oncology. Birmingham / Merck, Whitehouse Station, NJ
University of Alabama. Division of Gynecologic Oncology. Birmingham / Merck, Whitehouse Station, NJ
University of Alabama. Division of Gynecologic Oncology. Birmingham / Merck, Whitehouse Station, NJ
Broad Spectrum HPV Vaccine Study
Abstract: BACKGROUND: 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. (Funded by Merck; ClinicalTrials.gov number, NCT00543543).
DeCS: Alphapapillomavirus
Neoplasia Intraepitelial Cervical/prevenção & controle
Infecções por Papillomavirus/prevenção & controle
Vacinas contra Papillomavirus
Neoplasias do Colo do Útero/prevenção & controle
Adolescente
Adulto
Anticorpos Antivirais/sangue
Neoplasia Intraepitelial Cervical/virologia
Método Duplo-Cego
Feminino
Doenças dos Genitais Femininos/epidemiologia
Humanos
Incidência
Análise de Intenção de Tratamento
Infecções por Papillomavirus/epidemiologia
Vacinas contra Papillomavirus/administração & dosagem
Neoplasias do Colo do Útero/virologia
Issue Date: 2015
Publisher: Massachusetts Medical Society
Citation: JOURA, 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.
ISSN: 1533-4406
10.1056/NEJMoa1405044
Copyright: open access
Appears in Collections:BA - IGM - Artigos de Periódicos

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