Adjuvanted recombinant hemagglutinin H7 vaccine to highly pathogenic influenza A(H7N9) elicits high and sustained antibody responses in healthy adults

Abstract An unprecedented number of human infections with avian influenza A(H7N9) in the fifth epidemic wave during the winter of 2016–2017 in China and their antigenic divergence from the viruses that emerged in 2013 prompted development of updated vaccines for pandemic preparedness. We report on t...

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Autores principales:	Christine M. Oshansky, James King, Di Lu, James Zhou, Corrina Pavetto, Gary Horwith, Karen Biscardi, Bai Nguyen, John J. Treanor, Li-Mei Chen, Brett Jepson, BPI17002 Study Coordination Team, Rick A. Bright, Robert A. Johnson, Vittoria Cioce, Ruben O. Donis
Formato:	article
Lenguaje:	EN
Publicado:	Nature Portfolio 2021
Materias:	Immunologic diseases. Allergy RC581-607 Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC254-282
Acceso en línea:	https://doaj.org/article/be17f3c7ae07447ea0a02052839eac67
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spelling	oai:doaj.org-article:be17f3c7ae07447ea0a02052839eac672021-12-02T11:39:20ZAdjuvanted recombinant hemagglutinin H7 vaccine to highly pathogenic influenza A(H7N9) elicits high and sustained antibody responses in healthy adults10.1038/s41541-021-00287-72059-0105https://doaj.org/article/be17f3c7ae07447ea0a02052839eac672021-03-01T00:00:00Zhttps://doi.org/10.1038/s41541-021-00287-7https://doaj.org/toc/2059-0105Abstract An unprecedented number of human infections with avian influenza A(H7N9) in the fifth epidemic wave during the winter of 2016–2017 in China and their antigenic divergence from the viruses that emerged in 2013 prompted development of updated vaccines for pandemic preparedness. We report on the findings of a clinical study in healthy adults designed to evaluate the safety and immunogenicity of three dose levels of recombinant influenza vaccine derived from highly pathogenic A/Guangdong/17SF003/2016 (H7N9) virus adjuvanted with AS03 or MF59 oil-in water emulsions. Most of the six study groups meet the FDA CBER-specified vaccine licensure criterion of 70% seroprotection rate (SPR) for hemagglutination inhibition antibodies to the homologous virus. A substantial proportion of subjects show high cross-reactivity to antigenically distinct heterologous A(H7N9) viruses from the first epidemic wave of 2013. These results provide critical information to develop a pandemic response strategy and support regulatory requirements for vaccination under Emergency Use Authorization.Christine M. OshanskyJames KingDi LuJames ZhouCorrina PavettoGary HorwithKaren BiscardiBai NguyenJohn J. TreanorLi-Mei ChenBrett JepsonBPI17002 Study Coordination TeamRick A. BrightRobert A. JohnsonVittoria CioceRuben O. DonisNature PortfolioarticleImmunologic diseases. AllergyRC581-607Neoplasms. Tumors. Oncology. Including cancer and carcinogensRC254-282ENnpj Vaccines, Vol 6, Iss 1, Pp 1-8 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Immunologic diseases. Allergy RC581-607 Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC254-282
spellingShingle	Immunologic diseases. Allergy RC581-607 Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC254-282 Christine M. Oshansky James King Di Lu James Zhou Corrina Pavetto Gary Horwith Karen Biscardi Bai Nguyen John J. Treanor Li-Mei Chen Brett Jepson BPI17002 Study Coordination Team Rick A. Bright Robert A. Johnson Vittoria Cioce Ruben O. Donis Adjuvanted recombinant hemagglutinin H7 vaccine to highly pathogenic influenza A(H7N9) elicits high and sustained antibody responses in healthy adults
description	Abstract An unprecedented number of human infections with avian influenza A(H7N9) in the fifth epidemic wave during the winter of 2016–2017 in China and their antigenic divergence from the viruses that emerged in 2013 prompted development of updated vaccines for pandemic preparedness. We report on the findings of a clinical study in healthy adults designed to evaluate the safety and immunogenicity of three dose levels of recombinant influenza vaccine derived from highly pathogenic A/Guangdong/17SF003/2016 (H7N9) virus adjuvanted with AS03 or MF59 oil-in water emulsions. Most of the six study groups meet the FDA CBER-specified vaccine licensure criterion of 70% seroprotection rate (SPR) for hemagglutination inhibition antibodies to the homologous virus. A substantial proportion of subjects show high cross-reactivity to antigenically distinct heterologous A(H7N9) viruses from the first epidemic wave of 2013. These results provide critical information to develop a pandemic response strategy and support regulatory requirements for vaccination under Emergency Use Authorization.
format	article
author	Christine M. Oshansky James King Di Lu James Zhou Corrina Pavetto Gary Horwith Karen Biscardi Bai Nguyen John J. Treanor Li-Mei Chen Brett Jepson BPI17002 Study Coordination Team Rick A. Bright Robert A. Johnson Vittoria Cioce Ruben O. Donis
author_facet	Christine M. Oshansky James King Di Lu James Zhou Corrina Pavetto Gary Horwith Karen Biscardi Bai Nguyen John J. Treanor Li-Mei Chen Brett Jepson BPI17002 Study Coordination Team Rick A. Bright Robert A. Johnson Vittoria Cioce Ruben O. Donis
author_sort	Christine M. Oshansky
title	Adjuvanted recombinant hemagglutinin H7 vaccine to highly pathogenic influenza A(H7N9) elicits high and sustained antibody responses in healthy adults
title_short	Adjuvanted recombinant hemagglutinin H7 vaccine to highly pathogenic influenza A(H7N9) elicits high and sustained antibody responses in healthy adults
title_full	Adjuvanted recombinant hemagglutinin H7 vaccine to highly pathogenic influenza A(H7N9) elicits high and sustained antibody responses in healthy adults
title_fullStr	Adjuvanted recombinant hemagglutinin H7 vaccine to highly pathogenic influenza A(H7N9) elicits high and sustained antibody responses in healthy adults
title_full_unstemmed	Adjuvanted recombinant hemagglutinin H7 vaccine to highly pathogenic influenza A(H7N9) elicits high and sustained antibody responses in healthy adults
title_sort	adjuvanted recombinant hemagglutinin h7 vaccine to highly pathogenic influenza a(h7n9) elicits high and sustained antibody responses in healthy adults
publisher	Nature Portfolio
publishDate	2021
url	https://doaj.org/article/be17f3c7ae07447ea0a02052839eac67
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Adjuvanted recombinant hemagglutinin H7 vaccine to highly pathogenic influenza A(H7N9) elicits high and sustained antibody responses in healthy adults

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