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Phase II, randomized, open, controlled study of AS03-adjuvanted H5N1 pre-pandemic influenza vaccine in children aged 3 to 9 years: follow-up of safety and immunogenicity persistence at 24 months post-vaccination

BACKGROUND: An AS03-adjuvanted H5N1 influenza vaccine elicited broad and persistent immune responses with an acceptable safety profile up to 6 months following the first vaccination in children aged 3–9 years. METHODS: In this follow-up of the Phase II study, we report immunogenicity persistence and...

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Autores principales: Díez-Domingo, Javier, Baldó, José-María, Planelles-Catarino, Maria Victoria, Garcés-Sánchez, María, Ubeda, Isabel, Jubert–Rosich, Angels, Marès, Josep, Garcia-Corbeira, Pilar, Moris, Philippe, Teko, Maurice, Vanden Abeele, Carline, Gillard, Paul
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BlackWell Publishing Ltd 2015
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4353319/
https://www.ncbi.nlm.nih.gov/pubmed/25652873
http://dx.doi.org/10.1111/irv.12295
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author Díez-Domingo, Javier
Baldó, José-María
Planelles-Catarino, Maria Victoria
Garcés-Sánchez, María
Ubeda, Isabel
Jubert–Rosich, Angels
Marès, Josep
Garcia-Corbeira, Pilar
Moris, Philippe
Teko, Maurice
Vanden Abeele, Carline
Gillard, Paul
author_facet Díez-Domingo, Javier
Baldó, José-María
Planelles-Catarino, Maria Victoria
Garcés-Sánchez, María
Ubeda, Isabel
Jubert–Rosich, Angels
Marès, Josep
Garcia-Corbeira, Pilar
Moris, Philippe
Teko, Maurice
Vanden Abeele, Carline
Gillard, Paul
author_sort Díez-Domingo, Javier
collection PubMed
description BACKGROUND: An AS03-adjuvanted H5N1 influenza vaccine elicited broad and persistent immune responses with an acceptable safety profile up to 6 months following the first vaccination in children aged 3–9 years. METHODS: In this follow-up of the Phase II study, we report immunogenicity persistence and safety at 24 months post-vaccination in children aged 3–9 years. The randomized, open-label study assessed two doses of H5N1 A/Vietnam/1194/2004 influenza vaccine (1·9 μg or 3·75 μg hemagglutinin antigen) formulated with AS03(A) or AS03(B) (11·89 mg or 5·93 mg tocopherol, respectively). Control groups received seasonal trivalent influenza vaccine. Safety was assessed prospectively and included potential immune-mediated diseases (pIMDs). Immunogenicity was assessed by hemagglutination-inhibition assay 12 and 24 months after vaccination; cross-reactivity and cell-mediated responses were also assessed. (NCT00502593). RESULTS: The safety population included 405 children. Over 24 months, five events fulfilled the criteria for pIMDs, of which four occurred in H5N1 vaccine recipients, including uveitis (n = 1) and autoimmune hepatitis (n = 1), which were considered to be vaccine-related. Overall, safety profiles of the vaccines were clinically acceptable. Humoral immune responses at 12 and 24 months were reduced versus those observed after the second dose of vaccine, although still within the range of those observed after the first dose. Persistence of cell-mediated immunity was strong, and CD4(+) T cells with a T(H)1 profile were observed. CONCLUSIONS: Two doses of an AS03-adjuvanted H5N1 influenza vaccine in children showed low but persistent humoral immune responses and a strong persistence of cell-mediated immunity, with clinically acceptable safety profiles up to 24 months following first vaccination.
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spelling pubmed-43533192015-03-12 Phase II, randomized, open, controlled study of AS03-adjuvanted H5N1 pre-pandemic influenza vaccine in children aged 3 to 9 years: follow-up of safety and immunogenicity persistence at 24 months post-vaccination Díez-Domingo, Javier Baldó, José-María Planelles-Catarino, Maria Victoria Garcés-Sánchez, María Ubeda, Isabel Jubert–Rosich, Angels Marès, Josep Garcia-Corbeira, Pilar Moris, Philippe Teko, Maurice Vanden Abeele, Carline Gillard, Paul Influenza Other Respir Viruses Original Articles BACKGROUND: An AS03-adjuvanted H5N1 influenza vaccine elicited broad and persistent immune responses with an acceptable safety profile up to 6 months following the first vaccination in children aged 3–9 years. METHODS: In this follow-up of the Phase II study, we report immunogenicity persistence and safety at 24 months post-vaccination in children aged 3–9 years. The randomized, open-label study assessed two doses of H5N1 A/Vietnam/1194/2004 influenza vaccine (1·9 μg or 3·75 μg hemagglutinin antigen) formulated with AS03(A) or AS03(B) (11·89 mg or 5·93 mg tocopherol, respectively). Control groups received seasonal trivalent influenza vaccine. Safety was assessed prospectively and included potential immune-mediated diseases (pIMDs). Immunogenicity was assessed by hemagglutination-inhibition assay 12 and 24 months after vaccination; cross-reactivity and cell-mediated responses were also assessed. (NCT00502593). RESULTS: The safety population included 405 children. Over 24 months, five events fulfilled the criteria for pIMDs, of which four occurred in H5N1 vaccine recipients, including uveitis (n = 1) and autoimmune hepatitis (n = 1), which were considered to be vaccine-related. Overall, safety profiles of the vaccines were clinically acceptable. Humoral immune responses at 12 and 24 months were reduced versus those observed after the second dose of vaccine, although still within the range of those observed after the first dose. Persistence of cell-mediated immunity was strong, and CD4(+) T cells with a T(H)1 profile were observed. CONCLUSIONS: Two doses of an AS03-adjuvanted H5N1 influenza vaccine in children showed low but persistent humoral immune responses and a strong persistence of cell-mediated immunity, with clinically acceptable safety profiles up to 24 months following first vaccination. BlackWell Publishing Ltd 2015-03 2015-02-05 /pmc/articles/PMC4353319/ /pubmed/25652873 http://dx.doi.org/10.1111/irv.12295 Text en © 2014 The Authors. Influenza and Other Respiratory Viruses Published by John Wiley & Sons Ltd. http://creativecommons.org/licenses/by/4.0/ This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.
spellingShingle Original Articles
Díez-Domingo, Javier
Baldó, José-María
Planelles-Catarino, Maria Victoria
Garcés-Sánchez, María
Ubeda, Isabel
Jubert–Rosich, Angels
Marès, Josep
Garcia-Corbeira, Pilar
Moris, Philippe
Teko, Maurice
Vanden Abeele, Carline
Gillard, Paul
Phase II, randomized, open, controlled study of AS03-adjuvanted H5N1 pre-pandemic influenza vaccine in children aged 3 to 9 years: follow-up of safety and immunogenicity persistence at 24 months post-vaccination
title Phase II, randomized, open, controlled study of AS03-adjuvanted H5N1 pre-pandemic influenza vaccine in children aged 3 to 9 years: follow-up of safety and immunogenicity persistence at 24 months post-vaccination
title_full Phase II, randomized, open, controlled study of AS03-adjuvanted H5N1 pre-pandemic influenza vaccine in children aged 3 to 9 years: follow-up of safety and immunogenicity persistence at 24 months post-vaccination
title_fullStr Phase II, randomized, open, controlled study of AS03-adjuvanted H5N1 pre-pandemic influenza vaccine in children aged 3 to 9 years: follow-up of safety and immunogenicity persistence at 24 months post-vaccination
title_full_unstemmed Phase II, randomized, open, controlled study of AS03-adjuvanted H5N1 pre-pandemic influenza vaccine in children aged 3 to 9 years: follow-up of safety and immunogenicity persistence at 24 months post-vaccination
title_short Phase II, randomized, open, controlled study of AS03-adjuvanted H5N1 pre-pandemic influenza vaccine in children aged 3 to 9 years: follow-up of safety and immunogenicity persistence at 24 months post-vaccination
title_sort phase ii, randomized, open, controlled study of as03-adjuvanted h5n1 pre-pandemic influenza vaccine in children aged 3 to 9 years: follow-up of safety and immunogenicity persistence at 24 months post-vaccination
topic Original Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4353319/
https://www.ncbi.nlm.nih.gov/pubmed/25652873
http://dx.doi.org/10.1111/irv.12295
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