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Efficacy, immunogenicity, and safety of a 9-valent human papillomavirus vaccine in Latin American girls, boys, and young women / Ana María Guevara Zambrano
Título : Efficacy, immunogenicity, and safety of a 9-valent human papillomavirus vaccine in Latin American girls, boys, and young women Tipo de documento : documento electrónico Autores : Ana María Guevara Zambrano, Fecha de publicación : 2018 Títulos uniformes : Papillomavirus Research Idioma : Inglés (eng) Palabras clave : 9vHPV cervical cancer human papillomavirus persistent infection vaccine Resumen : Background: A 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. Mención de responsabilidad : Ángela María Ruiz-Sternberg, Edson D Moreira Jr, Jaime A Restrepo, Eduardo Lazcano-Ponce, Robinson Cabello, Arnaldo Silva, Rosires Andrade, Francisco Revollo, Santos Uscanga, Alejandro Victoria, Ana María Guevara, Joaquín Luna, Manuel Plata, Claudia Nossa Dominguez, Edison Fedrizzi, Eugenio Suarez, Julio C Reina, Misoo C Ellison, Erin Moeller, Michael Ritter, Christine Shields, Miguel Cashat, Gonzalo Perez, Alain Luxembourg Referencia : Papillomavirus Res. 2018 Jun;5:63-74. DOI (Digital Object Identifier) : 10.1016/j.pvr.2017.12.004 PMID : 29269325 Derechos de uso : CC BY-NC-ND En línea : https://linkinghub.elsevier.com/retrieve/pii/S2405852117300654 Enlace permanente : https://hospitalpablotobon.cloudbiteca.com/pmb/opac_css/index.php?lvl=notice_display&id=4196 Efficacy, immunogenicity, and safety of a 9-valent human papillomavirus vaccine in Latin American girls, boys, and young women [documento electrónico] / Ana María Guevara Zambrano, . - 2018.
Obra : Papillomavirus Research
Idioma : Inglés (eng)
Palabras clave : 9vHPV cervical cancer human papillomavirus persistent infection vaccine Resumen : Background: A 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. Mención de responsabilidad : Ángela María Ruiz-Sternberg, Edson D Moreira Jr, Jaime A Restrepo, Eduardo Lazcano-Ponce, Robinson Cabello, Arnaldo Silva, Rosires Andrade, Francisco Revollo, Santos Uscanga, Alejandro Victoria, Ana María Guevara, Joaquín Luna, Manuel Plata, Claudia Nossa Dominguez, Edison Fedrizzi, Eugenio Suarez, Julio C Reina, Misoo C Ellison, Erin Moeller, Michael Ritter, Christine Shields, Miguel Cashat, Gonzalo Perez, Alain Luxembourg Referencia : Papillomavirus Res. 2018 Jun;5:63-74. DOI (Digital Object Identifier) : 10.1016/j.pvr.2017.12.004 PMID : 29269325 Derechos de uso : CC BY-NC-ND En línea : https://linkinghub.elsevier.com/retrieve/pii/S2405852117300654 Enlace permanente : https://hospitalpablotobon.cloudbiteca.com/pmb/opac_css/index.php?lvl=notice_display&id=4196 Reserva
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Código de barras Número de Ubicación Tipo de medio Ubicación Sección Estado DD000810 AC-2018-097 Archivo digital Producción Científica Artículos científicos Disponible Documentos electrónicos
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