Antibody persistence and evidence of immune memory at 5 years following administration of the 9-valent HPV vaccine / Ana María Guevara Zambrano  

Público ISBD Título : Antibody persistence and evidence of immune memory at 5 years following administration of the 9-valent HPV vaccine Tipo de documento : documento electrónico Autores : Ana María Guevara Zambrano, Fecha de publicación : 2017 Títulos uniformes : Vaccine Idioma : Inglés (eng) Palabras clave : 9vHPV vaccine  Clinical trial  Human papillomavirus  Immune memory  Immunogenicity Resumen : Background: The 9-valent HPV (9vHPV) vaccine was developed to prevent infection and disease related to 9 HPV types (HPV6/11/16/18/31/33/45/52/58) which cause approximately 90% of cervical cancers, HPV-related vulvar, vaginal and anal cancers, and genital warts worldwide. In a pivotal efficacy study, the 9vHPV vaccine prevented infection and disease due to the 9 vaccine types. Duration of protection remains to be determined. Vaccines that induce long-term protection are generally characterized by the generation of immune memory. The purpose of this report is to assess the persistence of HPV antibody response and existence of immune memory at 5 years post-vaccination. Methods:A subset of subjects (N = 150) who received 3 doses of 9vHPV vaccine at day 1, month 2 and month 6 in the pivotal efficacy study continued in a study extension and received a fourth dose of 9vHPV vaccine at month 60. Serum HPV antibody levels were measured pre-dose 4 and at 7 and 28 days post-dose 4 by competitive Luminex immunoassay. Adverse events were assessed using a vaccination report card. Results: HPV antibodies induced following the 3-dose series of 9vHPV vaccine in the base study persisted through month 60 with seropositivity rates ranging from 77.5% to 100%. Geometric mean titers at 1 week and 1 month post-dose 4 were 1.25–4.10 and 1.65–4.88-fold higher, respectively, than levels observed 1 month following the completion of the three-dose primary series. Seropositivity rates were >99% and 100% at 1 week and 1 month post-dose 4, respectively. The fourth dose of 9vHPV vaccine was generally well tolerated. Conclusions: A three-dose regimen of the 9vHPV vaccine induced persistent HPV antibody response through 5 years post-vaccination. Administration of a fourth dose resulted in a strong anamnestic response to all 9 vaccine types. These findings suggest that the efficacy of the 9vHPV vaccine will be long lasting Mención de responsabilidad : Ana Guevara, Robinson Cabello, Linn Woelber, Edson Duarte Moreira Jr, Elmar Joura, Olaf Reich, Christine Shields, Misoo C Ellison, Amita Joshi, Alain Luxembourg Referencia : Vaccine. 2017 Sep 5;35(37):5050-5057. DOI (Digital Object Identifier) : 10.1016/j.vaccine.2017.07.017 PMID : 28789851 En línea : https://linkinghub.elsevier.com/retrieve/pii/S0264410X17309131 Enlace permanente : https://hospitalpablotobon.cloudbiteca.com/pmb/opac_css/index.php?lvl=notice_display&id=4034 Antibody persistence and evidence of immune memory at 5 years following administration of the 9-valent HPV vaccine [documento electrónico] / Ana María Guevara Zambrano,  . - 2017. Obra : Vaccine Idioma : Inglés (eng) Palabras clave : 9vHPV vaccine  Clinical trial  Human papillomavirus  Immune memory  Immunogenicity Resumen : Background: The 9-valent HPV (9vHPV) vaccine was developed to prevent infection and disease related to 9 HPV types (HPV6/11/16/18/31/33/45/52/58) which cause approximately 90% of cervical cancers, HPV-related vulvar, vaginal and anal cancers, and genital warts worldwide. In a pivotal efficacy study, the 9vHPV vaccine prevented infection and disease due to the 9 vaccine types. Duration of protection remains to be determined. Vaccines that induce long-term protection are generally characterized by the generation of immune memory. The purpose of this report is to assess the persistence of HPV antibody response and existence of immune memory at 5 years post-vaccination. Methods:A subset of subjects (N = 150) who received 3 doses of 9vHPV vaccine at day 1, month 2 and month 6 in the pivotal efficacy study continued in a study extension and received a fourth dose of 9vHPV vaccine at month 60. Serum HPV antibody levels were measured pre-dose 4 and at 7 and 28 days post-dose 4 by competitive Luminex immunoassay. Adverse events were assessed using a vaccination report card. Results: HPV antibodies induced following the 3-dose series of 9vHPV vaccine in the base study persisted through month 60 with seropositivity rates ranging from 77.5% to 100%. Geometric mean titers at 1 week and 1 month post-dose 4 were 1.25–4.10 and 1.65–4.88-fold higher, respectively, than levels observed 1 month following the completion of the three-dose primary series. Seropositivity rates were >99% and 100% at 1 week and 1 month post-dose 4, respectively. The fourth dose of 9vHPV vaccine was generally well tolerated. Conclusions: A three-dose regimen of the 9vHPV vaccine induced persistent HPV antibody response through 5 years post-vaccination. Administration of a fourth dose resulted in a strong anamnestic response to all 9 vaccine types. These findings suggest that the efficacy of the 9vHPV vaccine will be long lasting Mención de responsabilidad : Ana Guevara, Robinson Cabello, Linn Woelber, Edson Duarte Moreira Jr, Elmar Joura, Olaf Reich, Christine Shields, Misoo C Ellison, Amita Joshi, Alain Luxembourg Referencia : Vaccine. 2017 Sep 5;35(37):5050-5057. DOI (Digital Object Identifier) : 10.1016/j.vaccine.2017.07.017 PMID : 28789851 En línea : https://linkinghub.elsevier.com/retrieve/pii/S0264410X17309131 Enlace permanente : https://hospitalpablotobon.cloudbiteca.com/pmb/opac_css/index.php?lvl=notice_display&id=4034

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Immunogenicity and safety of the 9-valent HPV vaccine in men / Ana María Guevara Zambrano  

Público ISBD 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

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