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

Oshansky Cm ,Corrina Pavetto,Karen Biscardi,Bianca Nguyen ,Dan Lu ,Johnson Ra ,Jean-Rémi King ,Jun Zhou ,Gary Horwith,Lm Chen ,Cioce ,Brett Jepson,Bright Ra ,Treanor Jj ,Donis Ro

doi:10.1038/s41541-021-00287-7

Oshansky Cm , Corrina Pavetto + Show 13 more

Open Access

https://doi.org/10.1038/s41541-021-00287-7

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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.

Highlights

Zoonotic infections with a novel Asian lineage avian-origin influenza A(H7N9) virus were first reported in China in March 2013 and caused severe, often fatal, lower respiratory tract disease in humans[1,2]
Genetic and antigenic analyses indicated that more than 90% of the circulating H7N9 viruses belonged to a new group designated Yangtze River Delta lineage, antigenically distinct from the previously dominant Pearl River Delta lineage[4]
The new group had reduced cross-reactivity with antibodies raised to existing candidate vaccine viruses (CVVs) made in 2013, prompting the World Health Organization (WHO) to update the pandemic influenza vaccine recommendations[5]

Summary

Introduction

Zoonotic infections with a novel Asian lineage avian-origin influenza A(H7N9) virus were first reported in China in March 2013 and caused severe, often fatal, lower respiratory tract disease in humans[1,2]. Influenza A(H7N9) virus was found to be circulating in poultry in China, and until 2017, human epidemics have been reported annually between fall and early spring[3]. The influenza A(H7N9) viruses that emerged in 2013 were characterized by having low pathogenicity in chickens (low pathogenic avian influenza or LPAI), some of the Yangtze River Delta lineage viruses emerging in late 2016 were highly pathogenic for poultry (highly pathogenic avian influenza; HPAI) and caused several human infections[3,6].

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