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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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Título : Immunogenicity and safety of the 9-valent HPV vaccine in men Tipo de documento : documento electrónico Autores : Ana María Guevara Zambrano, Fecha de publicación : 2015 Títulos uniformes : Vaccine Idioma : Inglés (eng) Palabras clave : HPV vaccine men papillomavirus cancer Resumen : Objectives: This study was designed to evaluate the immunogenicity and tolerability of a prophylactic 9-valent HPV (types 6/11/16/18/31/33/45/52/58) VLP (9vHPV) vaccine in young men 16–26 years of age in comparison to young women 16–26 years of age (the population that was used to establish 9vHPV vaccine efficacy). Safety and immunogenicity data from this study will be used to bridge 9vHPV vaccine efficacy findings in 16–26 year old women to 16–26 year old men. Methods: This study enrolled 1106 heterosexual men (HM) and 1101 women who had not yet received HPV vaccination. In addition, 313 men having sex with men (MSM) were enrolled and were evaluated separately for immunogenicity because previous results showed that antibody responses to quadrivalent HPV (types 6/11/16/18) VLP (qHPV) vaccine were lower in MSM than in HM. All subjects were administered a 3-dose regimen (Day 1, Month 2, Month 6) of 9vHPV vaccine. Serum samples were collected for anti-HPV assays. Safety information was collected for ∼12 months. Results: The geometric mean titers (GMTs) for HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 for HM were non-inferior to those of women at Month 7. For all vaccine HPV types, Month 7 GMTs were numerically lower in MSM than in HM. Over 99.5% of subjects were seropositive at Month 7 for each vaccine HPV type. Administration of 9vHPV vaccine to both 16–26 year old men and women was generally well tolerated. Conclusions: These results support bridging the efficacy findings with 9vHPV vaccine in young women 16–26 years of age to men 16–26 years of age. Mención de responsabilidad : X Castellsagué, A R Giuliano, S Goldstone, A Guevara, O Mogensen, J M Palefsky, T Group, C Shields, K Liu, R Maansson, A Luxembourg, S S Kaplan Referencia : Vaccine. 2015 Nov 27;33(48):6892-901. DOI (Digital Object Identifier) : 10.1016/j.vaccine.2015.06.088 PMID : 26144901 En línea : https://linkinghub.elsevier.com/retrieve/pii/S0264-410X(15)00903-2 Enlace permanente : https://hospitalpablotobon.cloudbiteca.com/pmb/opac_css/index.php?lvl=notice_display&id=3891 Immunogenicity and safety of the 9-valent HPV vaccine in men [documento electrónico] / Ana María Guevara Zambrano, . - 2015.
Obra : Vaccine
Idioma : Inglés (eng)
Palabras clave : HPV vaccine men papillomavirus cancer Resumen : Objectives: This study was designed to evaluate the immunogenicity and tolerability of a prophylactic 9-valent HPV (types 6/11/16/18/31/33/45/52/58) VLP (9vHPV) vaccine in young men 16–26 years of age in comparison to young women 16–26 years of age (the population that was used to establish 9vHPV vaccine efficacy). Safety and immunogenicity data from this study will be used to bridge 9vHPV vaccine efficacy findings in 16–26 year old women to 16–26 year old men. Methods: This study enrolled 1106 heterosexual men (HM) and 1101 women who had not yet received HPV vaccination. In addition, 313 men having sex with men (MSM) were enrolled and were evaluated separately for immunogenicity because previous results showed that antibody responses to quadrivalent HPV (types 6/11/16/18) VLP (qHPV) vaccine were lower in MSM than in HM. All subjects were administered a 3-dose regimen (Day 1, Month 2, Month 6) of 9vHPV vaccine. Serum samples were collected for anti-HPV assays. Safety information was collected for ∼12 months. Results: The geometric mean titers (GMTs) for HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 for HM were non-inferior to those of women at Month 7. For all vaccine HPV types, Month 7 GMTs were numerically lower in MSM than in HM. Over 99.5% of subjects were seropositive at Month 7 for each vaccine HPV type. Administration of 9vHPV vaccine to both 16–26 year old men and women was generally well tolerated. Conclusions: These results support bridging the efficacy findings with 9vHPV vaccine in young women 16–26 years of age to men 16–26 years of age. Mención de responsabilidad : X Castellsagué, A R Giuliano, S Goldstone, A Guevara, O Mogensen, J M Palefsky, T Group, C Shields, K Liu, R Maansson, A Luxembourg, S S Kaplan Referencia : Vaccine. 2015 Nov 27;33(48):6892-901. DOI (Digital Object Identifier) : 10.1016/j.vaccine.2015.06.088 PMID : 26144901 En línea : https://linkinghub.elsevier.com/retrieve/pii/S0264-410X(15)00903-2 Enlace permanente : https://hospitalpablotobon.cloudbiteca.com/pmb/opac_css/index.php?lvl=notice_display&id=3891 Reserva
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Código de barras Número de Ubicación Tipo de medio Ubicación Sección Estado DD000471 AC-2015-024 Archivo digital Producción Científica Artículos científicos Disponible