tetano
Editor, Senior Moderator
NPJ Vaccines
. 2021 Mar 19;6(1):41.
doi: 10.1038/s41541-021-00287-7.
Adjuvanted recombinant hemagglutinin H7 vaccine to highly pathogenic influenza A(H7N9) elicits high and sustained antibody responses in healthy adults
Christine M Oshansky[SUP] 1 [/SUP], James King[SUP] 1 [/SUP], Di Lu[SUP] 1 [/SUP], James Zhou[SUP] 1 [/SUP], Corrina Pavetto[SUP] 1 [/SUP], Gary Horwith[SUP] 1 [/SUP], Karen Biscardi[SUP] 1 [/SUP], Bai Nguyen[SUP] 1 [/SUP], John J Treanor[SUP] 1 [/SUP], Li-Mei Chen[SUP] 1 [/SUP], Brett Jepson[SUP] 2 [/SUP], BPI17002 Study Coordination Team; Rick A Bright[SUP] 1 [/SUP], Robert A Johnson[SUP] 1 [/SUP], Vittoria Cioce[SUP] 1 [/SUP], Ruben O Donis[SUP] 3 [/SUP]
Collaborators, Affiliations
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.
. 2021 Mar 19;6(1):41.
doi: 10.1038/s41541-021-00287-7.
Adjuvanted recombinant hemagglutinin H7 vaccine to highly pathogenic influenza A(H7N9) elicits high and sustained antibody responses in healthy adults
Christine M Oshansky[SUP] 1 [/SUP], James King[SUP] 1 [/SUP], Di Lu[SUP] 1 [/SUP], James Zhou[SUP] 1 [/SUP], Corrina Pavetto[SUP] 1 [/SUP], Gary Horwith[SUP] 1 [/SUP], Karen Biscardi[SUP] 1 [/SUP], Bai Nguyen[SUP] 1 [/SUP], John J Treanor[SUP] 1 [/SUP], Li-Mei Chen[SUP] 1 [/SUP], Brett Jepson[SUP] 2 [/SUP], BPI17002 Study Coordination Team; Rick A Bright[SUP] 1 [/SUP], Robert A Johnson[SUP] 1 [/SUP], Vittoria Cioce[SUP] 1 [/SUP], Ruben O Donis[SUP] 3 [/SUP]
Collaborators, Affiliations
- PMID: 33741987
- DOI: 10.1038/s41541-021-00287-7
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.