Impact of baseline covariates on the immunogenicity of the 9-valent HPV vaccine - A combined analysis of five phase III clinical trials

Petersen, Lone K; Restrepo, Jaime; Moreira Junior, Edson Duarte; Iversen, Ole-Erik; Pitisuttithum, Punnee; Van Damme, Pierre; Joura, Elmar A; Olsson, Sven-Erik; Ferris, Daron; Block, Stan; Giuliano, Anna R; Bosch, Xavier; Pils, Sophie; Cuzick, Jack; Garland, Suzanne M; Huh, Warner; Kjaer, Susanne K; Bautista, Oliver M; Hyatt, Donna; Maansson, Roger; Moeller, Erin; Qi, Hong; Roberts, Christine; Luxembourg, Alain

Impact of baseline covariates on the immunogenicity of the 9-valent HPV vaccine - A combined analysis of five phase III clinical trials

Detalhes bibliográficos
Autor(a) principal:	Petersen, Lone K
Data de Publicação:	2017
Outros Autores:	Restrepo, Jaime, Moreira Junior, Edson Duarte, Iversen, Ole-Erik, Pitisuttithum, Punnee, Van Damme, Pierre, Joura, Elmar A, Olsson, Sven-Erik, Ferris, Daron, Block, Stan, Giuliano, Anna R, Bosch, Xavier, Pils, Sophie, Cuzick, Jack, Garland, Suzanne M, Huh, Warner, Kjaer, Susanne K, Bautista, Oliver M, Hyatt, Donna, Maansson, Roger, Moeller, Erin, Qi, Hong, Roberts, Christine, Luxembourg, Alain
Tipo de documento:	Artigo
Idioma:	eng
Título da fonte:	Repositório Institucional da FIOCRUZ (ARCA)
DOI:	10.1016/j.pvr.2017.03.002
Texto Completo:	https://www.arca.fiocruz.br/handle/icict/25793
Resumo:	Lone K. Petersena, Jaime Restrepob, Edson D. Moreira Jr., c, Ole-Erik Iversend, Punnee Pitisuttithume, Pierre Van Dammef, Elmar A. Jourag, Sven-Erik Olssonh, Daron Ferrisi, Stan Blockj, Anna R. Giulianok, Xavier Boschl, Sophie Pilsg, Jack Cuzickm, Suzanne M. Garlandn, Warner Huho, Susanne K. Kjaerp, Oliver M. Bautistaq, Donna Hyattq, Roger Maanssonq, Erin Moellerq, Hong Qiq, Christine Robertsq, Alain Luxembourgq,⁎ a Aarhus University Hospital, Department of Obstetrics and Gynecology, Aarhus, Denmark b Fundación Centro de Investigación Clínica CIC, Medellín, Colombia c Associação Obras Sociais Irmã Dulce and Oswaldo Cruz Foundation, Brazilian Ministry of Health, Bahia, Brazil d Department of Clinical Science, University of Bergen and Department of Gynecology and Obstetrics, Haukeland University Hospital, Bergen, Norway e Faculty of Tropical Medicine, Mahidol University, Nakhon Pathom, Thailand f Center for the Evaluation of Vaccination, University of Antwerp, Antwerp, Belgium g Medical University of Vienna, Comprehensive Cancer Center, Vienna, Austria h Karolinska Institute at Danderyd Hospital, Stockholm, Sweden i Department of Obstetrics and Gynecology, Georgia Regents University, Augusta, GA, USA j Kentucky Pediatric and Adult Research, Inc., Bardstown, KY, USA k Moffitt Cancer Center, Tampa, FL, USA l Catalan Institute of Oncology, Barcelona, Spain m Wolfson Institute of Preventive Medicine, London, UK n Royal Women’s Hospital, University of Melbourne and Murdoch Childrens Research Institute, Parkville, VIC, Australia o Division of Gynecologic Oncology, University of Alabama, Birmingham, USA p Danish Cancer Society Research Center and Department of Gynecology, Rigshospitalet, Denmark q Merck & Co., Inc., Kenilworth, NJ, USA

Metadados do item

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spelling	Petersen, Lone KRestrepo, JaimeMoreira Junior, Edson DuarteIversen, Ole-ErikPitisuttithum, PunneeVan Damme, PierreJoura, Elmar AOlsson, Sven-ErikFerris, DaronBlock, StanGiuliano, Anna RBosch, XavierPils, SophieCuzick, JackGarland, Suzanne MHuh, WarnerKjaer, Susanne KBautista, Oliver MHyatt, DonnaMaansson, RogerMoeller, ErinQi, HongRoberts, ChristineLuxembourg, Alain2018-04-12T12:41:55Z2018-04-12T12:41:55Z2017PETERSEN, L. K. et al. Impact of baseline covariates on the immunogenicity of the 9-valent HPV vaccine - A combined analysis of five phase III clinical trials. Papillomavirus Research, v. 3, p. 105–115, 2017.2405-8521https://www.arca.fiocruz.br/handle/icict/2579310.1016/j.pvr.2017.03.002Lone K. Petersena, Jaime Restrepob, Edson D. Moreira Jr., c, Ole-Erik Iversend, Punnee Pitisuttithume, Pierre Van Dammef, Elmar A. Jourag, Sven-Erik Olssonh, Daron Ferrisi, Stan Blockj, Anna R. Giulianok, Xavier Boschl, Sophie Pilsg, Jack Cuzickm, Suzanne M. Garlandn, Warner Huho, Susanne K. Kjaerp, Oliver M. Bautistaq, Donna Hyattq, Roger Maanssonq, Erin Moellerq, Hong Qiq, Christine Robertsq, Alain Luxembourgq,⁎ a Aarhus University Hospital, Department of Obstetrics and Gynecology, Aarhus, Denmark b Fundación Centro de Investigación Clínica CIC, Medellín, Colombia c Associação Obras Sociais Irmã Dulce and Oswaldo Cruz Foundation, Brazilian Ministry of Health, Bahia, Brazil d Department of Clinical Science, University of Bergen and Department of Gynecology and Obstetrics, Haukeland University Hospital, Bergen, Norway e Faculty of Tropical Medicine, Mahidol University, Nakhon Pathom, Thailand f Center for the Evaluation of Vaccination, University of Antwerp, Antwerp, Belgium g Medical University of Vienna, Comprehensive Cancer Center, Vienna, Austria h Karolinska Institute at Danderyd Hospital, Stockholm, Sweden i Department of Obstetrics and Gynecology, Georgia Regents University, Augusta, GA, USA j Kentucky Pediatric and Adult Research, Inc., Bardstown, KY, USA k Moffitt Cancer Center, Tampa, FL, USA l Catalan Institute of Oncology, Barcelona, Spain m Wolfson Institute of Preventive Medicine, London, UK n Royal Women’s Hospital, University of Melbourne and Murdoch Childrens Research Institute, Parkville, VIC, Australia o Division of Gynecologic Oncology, University of Alabama, Birmingham, USA p Danish Cancer Society Research Center and Department of Gynecology, Rigshospitalet, Denmark q Merck & Co., Inc., Kenilworth, NJ, USAMerck & Co., Inc., Kenilworth, NJ, USAAssociação Obras Sociais Irmã Dulce. Salvador, BA, Brasil / Fundação Oswaldo Cruz. Centro de Pesquisas Gonçalo Moniz. Salvador, BA, BrasilMúltipla – ver em NotasThe immunogenicity profile of the 9-valent HPV (9vHPV) vaccine was evaluated across five phase III clinical studies conducted in girls and boys 9-15 years of age and young women 16-26 years of age. The effect of baseline characteristics of subjects on vaccine-induced HPV antibody responses was assessed. Methods: Immunogenicity data from 11,304 subjects who received ≥1 dose of 9vHPV vaccine in five Phase III studies were analyzed. Vaccine was administered as a 3-dose regimen. HPV antibody titers were assessed 1 month after dose 3 using a competitive Luminex immunoassay and summarized as geometric mean titers (GMTs). Covariates examined were age, gender, race, region of residence, and HPV serostatus and PCR status at day 1. Results: GMTs to all 9 vaccine HPV types decreased with age at vaccination initiation, and were otherwise generally similar among the demographic subgroups defined by gender, race and region of residence. For all subgroups defined by race or region of residence, GMTs were higher in girls and boys than in young women. Vaccination of subjects who were seropositive at day 1 to a vaccine HPV type resulted in higher GMTs to that type, compared with those in subjects who were seronegative for that type at day 1. Conclusions: 9vHPV vaccine immunogenicity was robust among subjects with differing baseline characteristics. It was generally comparable across subjects of different races and from different regions. Greater immunogenicity in girls and boys versus young women (the population used to establish 9vHPV vaccine efficacy in clinical studies) indicates that the anti-HPV responses generated by the vaccine in adolescents from all races or regions were sufficient to induce high-level protective efficacy. This immunogenicity profile supports a widespread 9vHPV vaccination program and early vaccination.engElsevierVírus do papiloma humano9v Vacina contra o HPVImunogenicidadeEnsaio clínicoHuman papillomavirus9v HPV vaccineImmunogenicityClinical trialImpact of baseline covariates on the immunogenicity of the 9-valent HPV vaccine - A combined analysis of five phase III clinical trialsinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleinfo:eu-repo/semantics/openAccessreponame:Repositório Institucional da FIOCRUZ (ARCA)instname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZLICENSElicense.txtlicense.txttext/plain; charset=utf-82991https://www.arca.fiocruz.br/bitstream/icict/25793/1/license.txt5a560609d32a3863062d77ff32785d58MD51ORIGINALPetersen LK Impact of baseline covariates on the immunogenicity.pdfPetersen LK Impact of baseline covariates on the immunogenicity.pdfapplication/pdf483651https://www.arca.fiocruz.br/bitstream/icict/25793/2/Petersen%20LK%20Impact%20of%20baseline%20covariates%20on%20the%20immunogenicity.pdf9e3d21eb6906c14facabfd29716d4c70MD52TEXTPetersen LK Impact of baseline covariates on the immunogenicity.pdf.txtPetersen LK Impact of baseline covariates on the immunogenicity.pdf.txtExtracted texttext/plain57473https://www.arca.fiocruz.br/bitstream/icict/25793/3/Petersen%20LK%20Impact%20of%20baseline%20covariates%20on%20the%20immunogenicity.pdf.txt42fa6070e0fa4581ab6599211e13a9e9MD53icict/257932023-03-15 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dc.title.pt_BR.fl_str_mv	Impact of baseline covariates on the immunogenicity of the 9-valent HPV vaccine - A combined analysis of five phase III clinical trials
title	Impact of baseline covariates on the immunogenicity of the 9-valent HPV vaccine - A combined analysis of five phase III clinical trials
spellingShingle	Impact of baseline covariates on the immunogenicity of the 9-valent HPV vaccine - A combined analysis of five phase III clinical trials Petersen, Lone K Vírus do papiloma humano 9v Vacina contra o HPV Imunogenicidade Ensaio clínico Human papillomavirus 9v HPV vaccine Immunogenicity Clinical trial
title_short	Impact of baseline covariates on the immunogenicity of the 9-valent HPV vaccine - A combined analysis of five phase III clinical trials
title_full	Impact of baseline covariates on the immunogenicity of the 9-valent HPV vaccine - A combined analysis of five phase III clinical trials
title_fullStr	Impact of baseline covariates on the immunogenicity of the 9-valent HPV vaccine - A combined analysis of five phase III clinical trials
title_full_unstemmed	Impact of baseline covariates on the immunogenicity of the 9-valent HPV vaccine - A combined analysis of five phase III clinical trials
title_sort	Impact of baseline covariates on the immunogenicity of the 9-valent HPV vaccine - A combined analysis of five phase III clinical trials
author	Petersen, Lone K
author_facet	Petersen, Lone K Restrepo, Jaime Moreira Junior, Edson Duarte Iversen, Ole-Erik Pitisuttithum, Punnee Van Damme, Pierre Joura, Elmar A Olsson, Sven-Erik Ferris, Daron Block, Stan Giuliano, Anna R Bosch, Xavier Pils, Sophie Cuzick, Jack Garland, Suzanne M Huh, Warner Kjaer, Susanne K Bautista, Oliver M Hyatt, Donna Maansson, Roger Moeller, Erin Qi, Hong Roberts, Christine Luxembourg, Alain
author_role	author
author2	Restrepo, Jaime Moreira Junior, Edson Duarte Iversen, Ole-Erik Pitisuttithum, Punnee Van Damme, Pierre Joura, Elmar A Olsson, Sven-Erik Ferris, Daron Block, Stan Giuliano, Anna R Bosch, Xavier Pils, Sophie Cuzick, Jack Garland, Suzanne M Huh, Warner Kjaer, Susanne K Bautista, Oliver M Hyatt, Donna Maansson, Roger Moeller, Erin Qi, Hong Roberts, Christine Luxembourg, Alain
author2_role	author author author author author author author author author author author author author author author author author author author author author author author
dc.contributor.author.fl_str_mv	Petersen, Lone K Restrepo, Jaime Moreira Junior, Edson Duarte Iversen, Ole-Erik Pitisuttithum, Punnee Van Damme, Pierre Joura, Elmar A Olsson, Sven-Erik Ferris, Daron Block, Stan Giuliano, Anna R Bosch, Xavier Pils, Sophie Cuzick, Jack Garland, Suzanne M Huh, Warner Kjaer, Susanne K Bautista, Oliver M Hyatt, Donna Maansson, Roger Moeller, Erin Qi, Hong Roberts, Christine Luxembourg, Alain
dc.subject.other.pt_BR.fl_str_mv	Vírus do papiloma humano 9v Vacina contra o HPV Imunogenicidade Ensaio clínico
topic	Vírus do papiloma humano 9v Vacina contra o HPV Imunogenicidade Ensaio clínico Human papillomavirus 9v HPV vaccine Immunogenicity Clinical trial
dc.subject.en.pt_BR.fl_str_mv	Human papillomavirus 9v HPV vaccine Immunogenicity Clinical trial
description	Lone K. Petersena, Jaime Restrepob, Edson D. Moreira Jr., c, Ole-Erik Iversend, Punnee Pitisuttithume, Pierre Van Dammef, Elmar A. Jourag, Sven-Erik Olssonh, Daron Ferrisi, Stan Blockj, Anna R. Giulianok, Xavier Boschl, Sophie Pilsg, Jack Cuzickm, Suzanne M. Garlandn, Warner Huho, Susanne K. Kjaerp, Oliver M. Bautistaq, Donna Hyattq, Roger Maanssonq, Erin Moellerq, Hong Qiq, Christine Robertsq, Alain Luxembourgq,⁎ a Aarhus University Hospital, Department of Obstetrics and Gynecology, Aarhus, Denmark b Fundación Centro de Investigación Clínica CIC, Medellín, Colombia c Associação Obras Sociais Irmã Dulce and Oswaldo Cruz Foundation, Brazilian Ministry of Health, Bahia, Brazil d Department of Clinical Science, University of Bergen and Department of Gynecology and Obstetrics, Haukeland University Hospital, Bergen, Norway e Faculty of Tropical Medicine, Mahidol University, Nakhon Pathom, Thailand f Center for the Evaluation of Vaccination, University of Antwerp, Antwerp, Belgium g Medical University of Vienna, Comprehensive Cancer Center, Vienna, Austria h Karolinska Institute at Danderyd Hospital, Stockholm, Sweden i Department of Obstetrics and Gynecology, Georgia Regents University, Augusta, GA, USA j Kentucky Pediatric and Adult Research, Inc., Bardstown, KY, USA k Moffitt Cancer Center, Tampa, FL, USA l Catalan Institute of Oncology, Barcelona, Spain m Wolfson Institute of Preventive Medicine, London, UK n Royal Women’s Hospital, University of Melbourne and Murdoch Childrens Research Institute, Parkville, VIC, Australia o Division of Gynecologic Oncology, University of Alabama, Birmingham, USA p Danish Cancer Society Research Center and Department of Gynecology, Rigshospitalet, Denmark q Merck & Co., Inc., Kenilworth, NJ, USA
publishDate	2017
dc.date.issued.fl_str_mv	2017
dc.date.accessioned.fl_str_mv	2018-04-12T12:41:55Z
dc.date.available.fl_str_mv	2018-04-12T12:41:55Z
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	PETERSEN, L. K. et al. Impact of baseline covariates on the immunogenicity of the 9-valent HPV vaccine - A combined analysis of five phase III clinical trials. Papillomavirus Research, v. 3, p. 105–115, 2017.
dc.identifier.uri.fl_str_mv	https://www.arca.fiocruz.br/handle/icict/25793
dc.identifier.issn.pt_BR.fl_str_mv	2405-8521
dc.identifier.doi.none.fl_str_mv	10.1016/j.pvr.2017.03.002
identifier_str_mv	PETERSEN, L. K. et al. Impact of baseline covariates on the immunogenicity of the 9-valent HPV vaccine - A combined analysis of five phase III clinical trials. Papillomavirus Research, v. 3, p. 105–115, 2017. 2405-8521 10.1016/j.pvr.2017.03.002
url	https://www.arca.fiocruz.br/handle/icict/25793
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	Elsevier
publisher.none.fl_str_mv	Elsevier
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)
instacron_str	FIOCRUZ
institution	FIOCRUZ
reponame_str	Repositório Institucional da FIOCRUZ (ARCA)
collection	Repositório Institucional da FIOCRUZ (ARCA)
bitstream.url.fl_str_mv	https://www.arca.fiocruz.br/bitstream/icict/25793/1/license.txt https://www.arca.fiocruz.br/bitstream/icict/25793/2/Petersen%20LK%20Impact%20of%20baseline%20covariates%20on%20the%20immunogenicity.pdf https://www.arca.fiocruz.br/bitstream/icict/25793/3/Petersen%20LK%20Impact%20of%20baseline%20covariates%20on%20the%20immunogenicity.pdf.txt
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repository.name.fl_str_mv	Repositório Institucional da FIOCRUZ (ARCA) - Fundação Oswaldo Cruz (FIOCRUZ)
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Impact of baseline covariates on the immunogenicity of the 9-valent HPV vaccine - A combined analysis of five phase III clinical trials

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