Safety and reactogenicity of a quadrivalent human papillomavirus (types 6, 11, 16, 18) L1 viral-like-particle vaccine in older adolescents and young adults.

Moreira Júnior, Edson Duarte; Palefsky, Joel M; Giuliano, Anna R; Goldstone, Stephen; Aranda, Carlos; Jessen, Heiko; Hillman, Richard J; Ferris, Daron G; Coutlee, Francois; Vardas, Eftyhia; Marshall, J. Brooke; Vuocolo, Scott; Haupt, Richard M; Guris, Dalya; Garner, Elizabeth I. O

Safety and reactogenicity of a quadrivalent human papillomavirus (types 6, 11, 16, 18) L1 viral-like-particle vaccine in older adolescents and young adults.

Detalhes bibliográficos
Autor(a) principal:	Moreira Júnior, Edson Duarte
Data de Publicação:	2011
Outros Autores:	Palefsky, Joel M, Giuliano, Anna R, Goldstone, Stephen, Aranda, Carlos, Jessen, Heiko, Hillman, Richard J, Ferris, Daron G, Coutlee, Francois, Vardas, Eftyhia, Marshall, J. Brooke, Vuocolo, Scott, Haupt, Richard M, Guris, Dalya, Garner, Elizabeth I. O
Tipo de documento:	Artigo
Idioma:	eng
Título da fonte:	Repositório Institucional da FIOCRUZ (ARCA)
Texto Completo:	https://www.arca.fiocruz.br/handle/icict/9130
Resumo:	Associação Obras Sociais Irmã Dulce. Salvador, BA, Brasil / Fundação Oswaldo Cruz. Centro de Pesquisas Gonçalo Moniz. Salvador, BA, Brasil

Metadados do item

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network_name_str	Repositório Institucional da FIOCRUZ (ARCA)
repository_id_str	2135
spelling	Moreira Júnior, Edson DuartePalefsky, Joel MGiuliano, Anna RGoldstone, StephenAranda, CarlosJessen, HeikoHillman, Richard JFerris, Daron GCoutlee, FrancoisVardas, EftyhiaMarshall, J. BrookeVuocolo, ScottHaupt, Richard MGuris, DalyaGarner, Elizabeth I. O2014-12-09T17:39:03Z2014-12-09T17:39:03Z2011MOREIRA JUNIOR, E. D. et al. Safety and reactogenicity of a quadrivalent human papillomavirus (types 6, 11, 16, 18) L1 viral-like-particle vaccine in older adolescents and young adults. Human Vaccines, v. 7, n. 7, p. 768-775, 2011.1554-8619https://www.arca.fiocruz.br/handle/icict/9130dx.doi.org/10.4161/hv.7.7.15579engTaylor & FrancisSafety and reactogenicity of a quadrivalent human papillomavirus (types 6, 11, 16, 18) L1 viral-like-particle vaccine in older adolescents and young adults.info:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleAssociação Obras Sociais Irmã Dulce. Salvador, BA, Brasil / Fundação Oswaldo Cruz. Centro de Pesquisas Gonçalo Moniz. Salvador, BA, BrasilUniversity of California San Francisco. Department of Medicine. San Francisco, CA, USARisk Assessment, Detection. Tampa, FL, USA / Intervention Program. H. Lee Moffitt Cancer Center and Research Institute. Tampa, FL, USAMount Sinai School of Medicine. New York, NY, USAUniversity Medical Center. National Public Health Institute. Morelos, MexicoJ2: Private Clinic for Infectious Diseases. Berlin, GermanyUniversity of Sydney. STI Research Centre. Sydney, AustraliaMedical College of Georgia. Augusta, GA, USAUniversité de Montréal. Centre de recherche du CHUM. Montréal, QC, CanadaUniversity of Stellenbosch. South Africa. Division of Medical Virology. Johannesburg, South Africa / Lancet Laboratories. Johannesburg, South AfricaMerck & Co., Inc. North Wales, PA, USAMerck & Co., Inc. North Wales, PA, USAMerck & Co., Inc. North Wales, PA, USAMerck & Co., Inc. North Wales, PA, USAMerck & Co., Inc. North Wales, PA, USABackground: Prophylactic vaccination with a quadrivalent HPV (types 6, 11, 16, 18) vaccine (qHPV) has been shown to prevent infection with HPV 6/11/16/18 and associated disease in women and more recently, in men. Here we report on the safety and reactogenicity of the qHPV vaccine in males. A total of 4,065 healthy males aged 16-26 years were enrolled into a randomized, placebo-controlled, double-blind trial. Subjects were randomized 1:1 to receive qHPV vaccine or placebo at day 1, month 2, and month 6. Safety and tolerability were assessed via the collection of reported adverse experiences (AEs). All serious AEs (vaccine- or procedure-related or not) and all deaths occurring during the study were recorded. Safety analyses were conducted in all subjects who received at least one dose of vaccine or placebo. The proportion of subjects who reported at least one injection-site AE was higher in the qHPV vaccine group versus the placebo group (60.1% vs 53.7%, respectively), however most of these AEs were mild/moderate in intensity. The incidence of at least one systemic AE was comparable between the vaccine and placebo groups (31.7% vs 31.4%, respectively). There were no vaccine-related serious AEs or deaths. The occurrence of AEs did not increase with each successive injection, and among trial participants who were seropositive for at least one vaccine HPV type at enrollment, the profile of adverse events was similar to that of the entire study cohort. The qHPV vaccine was generally well tolerated in males aged 16-26 years and had a favorable safety profile.Human papillomavirus (HPV)VaccineSafetyMaleAdultAdolescentVacinas contra PapillomavirusVacinação/efeitos adversosAdolescenteAdultoMétodo Duplo-CegoFemininoPapillomavirus Humano 11/imunologiaPapillomavirus Humano 16/imunologiaHumanosMasculinoInfecções por Papillomavirus/imunologiaInfecções por Papillomavirus/prevenção & controleVacinas contra Papillomavirus/administração & dosagemVacinas contra Papillomavirus/efeitos adversosSegurançaAdulto Joveminfo:eu-repo/semantics/openAccessreponame:Repositório Institucional da FIOCRUZ (ARCA)instname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZLICENSElicense.txtlicense.txttext/plain; charset=utf-81914https://www.arca.fiocruz.br/bitstream/icict/9130/1/license.txt7d48279ffeed55da8dfe2f8e81f3b81fMD51ORIGINALMoreira ED Safety....pdfMoreira ED Safety....pdfapplication/pdf344870https://www.arca.fiocruz.br/bitstream/icict/9130/2/Moreira%20ED%20Safety....pdf56693cd2af4815866332739044dac845MD52TEXTMoreira ED Safety....pdf.txtMoreira ED Safety....pdf.txtExtracted texttext/plain43433https://www.arca.fiocruz.br/bitstream/icict/9130/3/Moreira%20ED%20Safety....pdf.txt9aa942d3e46f50bd164301ec2f6308a3MD53icict/91302023-03-15 14:33:23.586oai:www.arca.fiocruz.br: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ório InstitucionalPUBhttps://www.arca.fiocruz.br/oai/requestrepositorio.arca@fiocruz.bropendoar:21352023-03-15T17:33:23Repositório Institucional da FIOCRUZ (ARCA) - Fundação Oswaldo Cruz (FIOCRUZ)false
dc.title.pt_BR.fl_str_mv	Safety and reactogenicity of a quadrivalent human papillomavirus (types 6, 11, 16, 18) L1 viral-like-particle vaccine in older adolescents and young adults.
title	Safety and reactogenicity of a quadrivalent human papillomavirus (types 6, 11, 16, 18) L1 viral-like-particle vaccine in older adolescents and young adults.
spellingShingle	Safety and reactogenicity of a quadrivalent human papillomavirus (types 6, 11, 16, 18) L1 viral-like-particle vaccine in older adolescents and young adults. Moreira Júnior, Edson Duarte Human papillomavirus (HPV) Vaccine Safety Male Adult Adolescent Vacinas contra Papillomavirus Vacinação/efeitos adversos Adolescente Adulto Método Duplo-Cego Feminino Papillomavirus Humano 11/imunologia Papillomavirus Humano 16/imunologia Humanos Masculino Infecções por Papillomavirus/imunologia Infecções por Papillomavirus/prevenção & controle Vacinas contra Papillomavirus/administração & dosagem Vacinas contra Papillomavirus/efeitos adversos Segurança Adulto Jovem
title_short	Safety and reactogenicity of a quadrivalent human papillomavirus (types 6, 11, 16, 18) L1 viral-like-particle vaccine in older adolescents and young adults.
title_full	Safety and reactogenicity of a quadrivalent human papillomavirus (types 6, 11, 16, 18) L1 viral-like-particle vaccine in older adolescents and young adults.
title_fullStr	Safety and reactogenicity of a quadrivalent human papillomavirus (types 6, 11, 16, 18) L1 viral-like-particle vaccine in older adolescents and young adults.
title_full_unstemmed	Safety and reactogenicity of a quadrivalent human papillomavirus (types 6, 11, 16, 18) L1 viral-like-particle vaccine in older adolescents and young adults.
title_sort	Safety and reactogenicity of a quadrivalent human papillomavirus (types 6, 11, 16, 18) L1 viral-like-particle vaccine in older adolescents and young adults.
author	Moreira Júnior, Edson Duarte
author_facet	Moreira Júnior, Edson Duarte Palefsky, Joel M Giuliano, Anna R Goldstone, Stephen Aranda, Carlos Jessen, Heiko Hillman, Richard J Ferris, Daron G Coutlee, Francois Vardas, Eftyhia Marshall, J. Brooke Vuocolo, Scott Haupt, Richard M Guris, Dalya Garner, Elizabeth I. O
author_role	author
author2	Palefsky, Joel M Giuliano, Anna R Goldstone, Stephen Aranda, Carlos Jessen, Heiko Hillman, Richard J Ferris, Daron G Coutlee, Francois Vardas, Eftyhia Marshall, J. Brooke Vuocolo, Scott Haupt, Richard M Guris, Dalya Garner, Elizabeth I. O
author2_role	author author author author author author author author author author author author author author
dc.contributor.author.fl_str_mv	Moreira Júnior, Edson Duarte Palefsky, Joel M Giuliano, Anna R Goldstone, Stephen Aranda, Carlos Jessen, Heiko Hillman, Richard J Ferris, Daron G Coutlee, Francois Vardas, Eftyhia Marshall, J. Brooke Vuocolo, Scott Haupt, Richard M Guris, Dalya Garner, Elizabeth I. O
dc.subject.en.pt_BR.fl_str_mv	Human papillomavirus (HPV) Vaccine Safety Male Adult Adolescent
topic	Human papillomavirus (HPV) Vaccine Safety Male Adult Adolescent Vacinas contra Papillomavirus Vacinação/efeitos adversos Adolescente Adulto Método Duplo-Cego Feminino Papillomavirus Humano 11/imunologia Papillomavirus Humano 16/imunologia Humanos Masculino Infecções por Papillomavirus/imunologia Infecções por Papillomavirus/prevenção & controle Vacinas contra Papillomavirus/administração & dosagem Vacinas contra Papillomavirus/efeitos adversos Segurança Adulto Jovem
dc.subject.decs.pt_BR.fl_str_mv	Vacinas contra Papillomavirus Vacinação/efeitos adversos Adolescente Adulto Método Duplo-Cego Feminino Papillomavirus Humano 11/imunologia Papillomavirus Humano 16/imunologia Humanos Masculino Infecções por Papillomavirus/imunologia Infecções por Papillomavirus/prevenção & controle Vacinas contra Papillomavirus/administração & dosagem Vacinas contra Papillomavirus/efeitos adversos Segurança Adulto Jovem
description	Associação Obras Sociais Irmã Dulce. Salvador, BA, Brasil / Fundação Oswaldo Cruz. Centro de Pesquisas Gonçalo Moniz. Salvador, BA, Brasil
publishDate	2011
dc.date.issued.fl_str_mv	2011
dc.date.accessioned.fl_str_mv	2014-12-09T17:39:03Z
dc.date.available.fl_str_mv	2014-12-09T17:39:03Z
dc.type.status.fl_str_mv	info:eu-repo/semantics/publishedVersion
dc.type.driver.fl_str_mv	info:eu-repo/semantics/article
format	article
status_str	publishedVersion
dc.identifier.citation.fl_str_mv	MOREIRA JUNIOR, E. D. et al. Safety and reactogenicity of a quadrivalent human papillomavirus (types 6, 11, 16, 18) L1 viral-like-particle vaccine in older adolescents and young adults. Human Vaccines, v. 7, n. 7, p. 768-775, 2011.
dc.identifier.uri.fl_str_mv	https://www.arca.fiocruz.br/handle/icict/9130
dc.identifier.issn.none.fl_str_mv	1554-8619
dc.identifier.doi.none.fl_str_mv	dx.doi.org/10.4161/hv.7.7.15579
identifier_str_mv	MOREIRA JUNIOR, E. D. et al. Safety and reactogenicity of a quadrivalent human papillomavirus (types 6, 11, 16, 18) L1 viral-like-particle vaccine in older adolescents and young adults. Human Vaccines, v. 7, n. 7, p. 768-775, 2011. 1554-8619 dx.doi.org/10.4161/hv.7.7.15579
url	https://www.arca.fiocruz.br/handle/icict/9130
dc.language.iso.fl_str_mv	eng
language	eng
dc.rights.driver.fl_str_mv	info:eu-repo/semantics/openAccess
eu_rights_str_mv	openAccess
dc.publisher.none.fl_str_mv	Taylor & Francis
publisher.none.fl_str_mv	Taylor & Francis
dc.source.none.fl_str_mv	reponame:Repositório Institucional da FIOCRUZ (ARCA) instname:Fundação Oswaldo Cruz (FIOCRUZ) instacron:FIOCRUZ
instname_str	Fundação Oswaldo Cruz (FIOCRUZ)
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reponame_str	Repositório Institucional da FIOCRUZ (ARCA)
collection	Repositório Institucional da FIOCRUZ (ARCA)
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Safety and reactogenicity of a quadrivalent human papillomavirus (types 6, 11, 16, 18) L1 viral-like-particle vaccine in older adolescents and young adults.

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