Efficacy, immunogenicity, and safety of a 9-valent human papillomavirus vaccine in Latin American girls, boys, and young women

Detalhes bibliográficos
Autor(a) principal: Sternberg, Ángela María Ruiz
Data de Publicação: 2018
Outros Autores: Moreira Junior, Edson Duarte, Restrepo, Jaime A., Ponce, Eduardo Lazcano, Cabello, Robinson, Silva, Arnaldo, Andrade, Rosires, Revollo, Francisco, Uscanga, Santos, Victoria, Alejandro, Guevara, Ana María, Luna, Joaquín, Plata, Manuel, Dominguez, Claudia Nossa, Fedrizzi, Edison, Suarez, Eugenio, Reina, Julio C., Ellison, Misoo C., Moeller, Erin, Ritter, Michael, Shields, Christine, Cashat, Miguel, Perez, Gonzalo, Luxembourg, Alain
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Institucional da FIOCRUZ (ARCA)
Texto Completo: https://www.arca.fiocruz.br/handle/icict/26442
Resumo: Moreira Junior, Edson Duarte. Associação Obras Sociais Irmã Dulce / Fundação Oswaldo Cruz. Centro de Pesquisas Gonçalo Moniz. Salvador, BA, Brasil. a Clinical Research Group, Universidad del Rosario, Bogotá, Colombia b Associação Obras Sociais Irmã Dulce and Oswaldo Cruz Foundation, Brazilian Ministry of Health, Bahia, Brazil c Foundation Clinical Research Center CIC, Medellín, Colombia d Research Center on Public Health, National Institute of Public Health, Cuernavaca, Morelos, Mexico e Via Libre Association, Lima, Peru f Hospital Nacional Arzobispo Loayza, Lima, Peru g Departamento de Tocoginecologia da Universidade Federal do Paraná, Curitiba, Brazil h Centro de Investigaciones, Hospital Universitario San Ignacio, Bogotá, Colombia i Arké Estudios Clínicos S.A. de C.V., Mexico City, Mexico j Department of Obstetrics and Gynecology, Fundacion Valle del Lili, Cali, Colombia k Research Unit, Pablo Tobon Uribe Hospital, Medellin, Colombia l Departamento de Ginecología y Obstetricia Clínica Colsanitas, Fundación Universitaria Sanitas, Bogotá, Colombia mDepartment of Gynecology, Fundación Cardioinfantil, Bogotá, Colombia n CAFAM, Bogotá, Colombia o Department of Gynecology and Obstetrics, University of Santa Catarina, Florianópolis, Santa Catarina, Brazil p Gynecological Oncology Division Hospital Clinico San Borja Arriaran Universidad de Chile Campus Centro, Santiago, Chile q Department of Pediatrics, Universidad del Valle and Centro Medico Imbanaco, Cali, Colombia r Merck & Co., Inc., Kenilworth, NJ, USA
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spelling Sternberg, Ángela María RuizMoreira Junior, Edson DuarteRestrepo, Jaime A.Ponce, Eduardo LazcanoCabello, RobinsonSilva, ArnaldoAndrade, RosiresRevollo, FranciscoUscanga, SantosVictoria, AlejandroGuevara, Ana MaríaLuna, JoaquínPlata, ManuelDominguez, Claudia NossaFedrizzi, EdisonSuarez, EugenioReina, Julio C.Ellison, Misoo C.Moeller, ErinRitter, MichaelShields, ChristineCashat, MiguelPerez, GonzaloLuxembourg, Alain2018-05-15T12:46:02Z2018-05-15T12:46:02Z2018STEMBERG, Ángela María Ruiz et al. Efficacy, immunogenicity, and safety of a 9-valent human papillomavirus vaccine in Latin American girls, boys, and young women. Papillomavirus Research, v. 5, p. 1-12, 2018.2405-8521https://www.arca.fiocruz.br/handle/icict/2644210.1016/j.pvr.2017.12.004Moreira Junior, Edson Duarte. Associação Obras Sociais Irmã Dulce / Fundação Oswaldo Cruz. Centro de Pesquisas Gonçalo Moniz. Salvador, BA, Brasil. a Clinical Research Group, Universidad del Rosario, Bogotá, Colombia b Associação Obras Sociais Irmã Dulce and Oswaldo Cruz Foundation, Brazilian Ministry of Health, Bahia, Brazil c Foundation Clinical Research Center CIC, Medellín, Colombia d Research Center on Public Health, National Institute of Public Health, Cuernavaca, Morelos, Mexico e Via Libre Association, Lima, Peru f Hospital Nacional Arzobispo Loayza, Lima, Peru g Departamento de Tocoginecologia da Universidade Federal do Paraná, Curitiba, Brazil h Centro de Investigaciones, Hospital Universitario San Ignacio, Bogotá, Colombia i Arké Estudios Clínicos S.A. de C.V., Mexico City, Mexico j Department of Obstetrics and Gynecology, Fundacion Valle del Lili, Cali, Colombia k Research Unit, Pablo Tobon Uribe Hospital, Medellin, Colombia l Departamento de Ginecología y Obstetricia Clínica Colsanitas, Fundación Universitaria Sanitas, Bogotá, Colombia mDepartment of Gynecology, Fundación Cardioinfantil, Bogotá, Colombia n CAFAM, Bogotá, Colombia o Department of Gynecology and Obstetrics, University of Santa Catarina, Florianópolis, Santa Catarina, Brazil p Gynecological Oncology Division Hospital Clinico San Borja Arriaran Universidad de Chile Campus Centro, Santiago, Chile q Department of Pediatrics, Universidad del Valle and Centro Medico Imbanaco, Cali, Colombia r 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, Brasil.Múltipla - ver em NotasA 9-valent human papillomavirus (HPV6/11/16/18/31/33/45/52/58; 9vHPV) vaccine was developed to expand coverage of the previously developed quadrivalent (HPV6/11/16/18; qHPV) vaccine. Methods: Efficacy, immunogenicity, and safety outcomes were assessed in Latin American participants enrolled in 2 international studies of the 9vHPV vaccine, including a randomized, double-blinded, controlled with qHPV vaccine, efficacy, immunogenicity, and safety study in young women aged 16–26 years, and an immunogenicity and safety study in girls and boys aged 9–15 years. Participants (N=5312) received vaccination at Day 1, Month 2, and Month 6. Gynecological swabs were collected regularly in young women for cytological and HPV DNA testing. Serum was analyzed for HPV antibodies in all participants. Adverse events (AEs) were also monitored in all participants. Results: The 9vHPV vaccine prevented HPV 31-, 33-, 45-, 52-, and 58-related high-grade cervical, vulvar, and vaginal dysplasia with 92.3% efficacy (95% confidence interval 54.4, 99.6). Anti-HPV6, 11, 16, and 18 geometric mean titers at Month 7 were similar in the 9vHPV and qHPV vaccination groups. Anti-HPV antibody responses following vaccination were higher among girls and boys than in young women. Most (> 99%) 9vHPV vaccine recipients seroconverted for all 9 HPV types at Month 7. Antibody responses to the 9 HPV types persisted over 5 years. The most common AEs were injection-site related, mostly of mild to moderate intensity. Conclusions: The 9vHPV vaccine is efficacious, immunogenic, and well tolerated in Latin American young women, girls, and boys. These data support 9vHPV vaccination programs in Latin America, a region with substantial cervical cancer burden.engElsevierEfficacy, immunogenicity, and safety of a 9-valent human papillomavirus vaccine in Latin American girls, boys, and young womeninfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleHuman papillomavirusVaccineCervical cancerPersistent infection9vHPVinfo: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/26442/1/license.txt5a560609d32a3863062d77ff32785d58MD51ORIGINALSternberg A Efficacy, immunogenicity, and safety .....pdfSternberg A Efficacy, immunogenicity, and safety 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dc.title.pt_BR.fl_str_mv Efficacy, immunogenicity, and safety of a 9-valent human papillomavirus vaccine in Latin American girls, boys, and young women
title Efficacy, immunogenicity, and safety of a 9-valent human papillomavirus vaccine in Latin American girls, boys, and young women
spellingShingle Efficacy, immunogenicity, and safety of a 9-valent human papillomavirus vaccine in Latin American girls, boys, and young women
Sternberg, Ángela María Ruiz
Human papillomavirus
Vaccine
Cervical cancer
Persistent infection
9vHPV
title_short Efficacy, immunogenicity, and safety of a 9-valent human papillomavirus vaccine in Latin American girls, boys, and young women
title_full Efficacy, immunogenicity, and safety of a 9-valent human papillomavirus vaccine in Latin American girls, boys, and young women
title_fullStr Efficacy, immunogenicity, and safety of a 9-valent human papillomavirus vaccine in Latin American girls, boys, and young women
title_full_unstemmed Efficacy, immunogenicity, and safety of a 9-valent human papillomavirus vaccine in Latin American girls, boys, and young women
title_sort Efficacy, immunogenicity, and safety of a 9-valent human papillomavirus vaccine in Latin American girls, boys, and young women
author Sternberg, Ángela María Ruiz
author_facet Sternberg, Ángela María Ruiz
Moreira Junior, Edson Duarte
Restrepo, Jaime A.
Ponce, Eduardo Lazcano
Cabello, Robinson
Silva, Arnaldo
Andrade, Rosires
Revollo, Francisco
Uscanga, Santos
Victoria, Alejandro
Guevara, Ana María
Luna, Joaquín
Plata, Manuel
Dominguez, Claudia Nossa
Fedrizzi, Edison
Suarez, Eugenio
Reina, Julio C.
Ellison, Misoo C.
Moeller, Erin
Ritter, Michael
Shields, Christine
Cashat, Miguel
Perez, Gonzalo
Luxembourg, Alain
author_role author
author2 Moreira Junior, Edson Duarte
Restrepo, Jaime A.
Ponce, Eduardo Lazcano
Cabello, Robinson
Silva, Arnaldo
Andrade, Rosires
Revollo, Francisco
Uscanga, Santos
Victoria, Alejandro
Guevara, Ana María
Luna, Joaquín
Plata, Manuel
Dominguez, Claudia Nossa
Fedrizzi, Edison
Suarez, Eugenio
Reina, Julio C.
Ellison, Misoo C.
Moeller, Erin
Ritter, Michael
Shields, Christine
Cashat, Miguel
Perez, Gonzalo
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 Sternberg, Ángela María Ruiz
Moreira Junior, Edson Duarte
Restrepo, Jaime A.
Ponce, Eduardo Lazcano
Cabello, Robinson
Silva, Arnaldo
Andrade, Rosires
Revollo, Francisco
Uscanga, Santos
Victoria, Alejandro
Guevara, Ana María
Luna, Joaquín
Plata, Manuel
Dominguez, Claudia Nossa
Fedrizzi, Edison
Suarez, Eugenio
Reina, Julio C.
Ellison, Misoo C.
Moeller, Erin
Ritter, Michael
Shields, Christine
Cashat, Miguel
Perez, Gonzalo
Luxembourg, Alain
dc.subject.en.pt_BR.fl_str_mv Human papillomavirus
Vaccine
Cervical cancer
Persistent infection
9vHPV
topic Human papillomavirus
Vaccine
Cervical cancer
Persistent infection
9vHPV
description Moreira Junior, Edson Duarte. Associação Obras Sociais Irmã Dulce / Fundação Oswaldo Cruz. Centro de Pesquisas Gonçalo Moniz. Salvador, BA, Brasil. a Clinical Research Group, Universidad del Rosario, Bogotá, Colombia b Associação Obras Sociais Irmã Dulce and Oswaldo Cruz Foundation, Brazilian Ministry of Health, Bahia, Brazil c Foundation Clinical Research Center CIC, Medellín, Colombia d Research Center on Public Health, National Institute of Public Health, Cuernavaca, Morelos, Mexico e Via Libre Association, Lima, Peru f Hospital Nacional Arzobispo Loayza, Lima, Peru g Departamento de Tocoginecologia da Universidade Federal do Paraná, Curitiba, Brazil h Centro de Investigaciones, Hospital Universitario San Ignacio, Bogotá, Colombia i Arké Estudios Clínicos S.A. de C.V., Mexico City, Mexico j Department of Obstetrics and Gynecology, Fundacion Valle del Lili, Cali, Colombia k Research Unit, Pablo Tobon Uribe Hospital, Medellin, Colombia l Departamento de Ginecología y Obstetricia Clínica Colsanitas, Fundación Universitaria Sanitas, Bogotá, Colombia mDepartment of Gynecology, Fundación Cardioinfantil, Bogotá, Colombia n CAFAM, Bogotá, Colombia o Department of Gynecology and Obstetrics, University of Santa Catarina, Florianópolis, Santa Catarina, Brazil p Gynecological Oncology Division Hospital Clinico San Borja Arriaran Universidad de Chile Campus Centro, Santiago, Chile q Department of Pediatrics, Universidad del Valle and Centro Medico Imbanaco, Cali, Colombia r Merck & Co., Inc., Kenilworth, NJ, USA
publishDate 2018
dc.date.accessioned.fl_str_mv 2018-05-15T12:46:02Z
dc.date.available.fl_str_mv 2018-05-15T12:46:02Z
dc.date.issued.fl_str_mv 2018
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
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dc.identifier.citation.fl_str_mv STEMBERG, Ángela María Ruiz et al. Efficacy, immunogenicity, and safety of a 9-valent human papillomavirus vaccine in Latin American girls, boys, and young women. Papillomavirus Research, v. 5, p. 1-12, 2018.
dc.identifier.uri.fl_str_mv https://www.arca.fiocruz.br/handle/icict/26442
dc.identifier.issn.pt_BR.fl_str_mv 2405-8521
dc.identifier.doi.none.fl_str_mv 10.1016/j.pvr.2017.12.004
identifier_str_mv STEMBERG, Ángela María Ruiz et al. Efficacy, immunogenicity, and safety of a 9-valent human papillomavirus vaccine in Latin American girls, boys, and young women. Papillomavirus Research, v. 5, p. 1-12, 2018.
2405-8521
10.1016/j.pvr.2017.12.004
url https://www.arca.fiocruz.br/handle/icict/26442
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)
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