Tweet
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 1 , James King 1 , Di Lu 1 , James Zhou 1 , Corrina Pavetto 1 , Gary Horwith 1 , Karen Biscardi 1 , Bai Nguyen 1 , John J Treanor 1 , Li-Mei Chen 1 , Brett Jepson 2 , BPI17002 Study Coordination Team; Rick A Bright 1 , Robert A Johnson 1 , Vittoria Cioce 1 , Ruben O Donis 3
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.