Single-dose avian influenza A(H5N1) Clade 2.3.4.4b hemagglutinin–Matrix-M® nanoparticle vaccine induces neutralizing responses in nonhuman primates

Abstract With the recent rise in cases of highly pathogenic avian influenza (HPAI) A(H5N1) clade 2.3.4.4b infection in humans and animals, there is an associated increase in the risk of human-to-human transmission. In this study, we characterize a recombinant A(H5N1) A/American Wigeon/South Carolina...

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Main Authors: Nita Patel, Asma Rehman, Jessica F. Trost, Rhonda Flores, Zach Longacre, Mimi Guebre-Xabier, Haixia Zhou, Bin Zhou, Kelsey Jacobson, Desheng Jiang, Xiaoyun Bai, Rafia Khatoon, Thomas Kort, James Norton, M. Madhangi, Melinda Hersey, Ann M. Greene, Filip Dubovsky, Gale Smith
Format: Article
Language:English
Published: Nature Portfolio 2025-07-01
Series:Nature Communications
Online Access:https://doi.org/10.1038/s41467-025-61964-y
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author Nita Patel
Asma Rehman
Jessica F. Trost
Rhonda Flores
Zach Longacre
Mimi Guebre-Xabier
Haixia Zhou
Bin Zhou
Kelsey Jacobson
Desheng Jiang
Xiaoyun Bai
Rafia Khatoon
Thomas Kort
James Norton
M. Madhangi
Melinda Hersey
Ann M. Greene
Filip Dubovsky
Gale Smith
author_facet Nita Patel
Asma Rehman
Jessica F. Trost
Rhonda Flores
Zach Longacre
Mimi Guebre-Xabier
Haixia Zhou
Bin Zhou
Kelsey Jacobson
Desheng Jiang
Xiaoyun Bai
Rafia Khatoon
Thomas Kort
James Norton
M. Madhangi
Melinda Hersey
Ann M. Greene
Filip Dubovsky
Gale Smith
author_sort Nita Patel
collection DOAJ
description Abstract With the recent rise in cases of highly pathogenic avian influenza (HPAI) A(H5N1) clade 2.3.4.4b infection in humans and animals, there is an associated increase in the risk of human-to-human transmission. In this study, we characterize a recombinant A(H5N1) A/American Wigeon/South Carolina/22/000345-001/2021 (A/AW/SC/2021) clade 2.3.4.4b vaccine. Purified recombinant A/AW/SC/2021 HA trimers formulated with Matrix-M® adjuvant, saponin-cholesterol-phospholipid combination arranged in cage-like particles, are found to non-covalently anchor to the vertices of the Matrix-M and form A(H5N1) HA–Matrix-M nanoparticles (H5-MNPs). In naïve female mice, two intranasal (IN) or intramuscular (IM) doses of A/AW/SC/2021 H5-MNP vaccine induces robust antibody- and cell-mediated immune responses, including neutralizing antibodies against A(H5N1). In non-human primates (NHPs) primed with seasonal influenza vaccine, a single IM or IN dose of the A/AW/SC/2021 H5-MNP vaccine induces geometric mean serum A(H5N1) clade 2.3.4.4b pseudovirus neutralizing titers of 1:1160 and 1:54, respectively; above the generally accepted seroconverting neutralizing titer of 1:40. Immunization with H5-MNP vaccine induces antibody responses against conserved epitopes in the A(H5N1) HA stem, vestigial esterase subdomain, and receptor binding site. This A(H5N1) H5-MNP IN and IM vaccine is immunogenic in female rodents and NHPs as a potential A(H5N1) pandemic single-dose vaccine.
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spelling doaj-art-0e2fea8564ab46dcb5be013a12c7335e2025-08-20T03:05:06ZengNature PortfolioNature Communications2041-17232025-07-0116111610.1038/s41467-025-61964-ySingle-dose avian influenza A(H5N1) Clade 2.3.4.4b hemagglutinin–Matrix-M® nanoparticle vaccine induces neutralizing responses in nonhuman primatesNita Patel0Asma Rehman1Jessica F. Trost2Rhonda Flores3Zach Longacre4Mimi Guebre-Xabier5Haixia Zhou6Bin Zhou7Kelsey Jacobson8Desheng Jiang9Xiaoyun Bai10Rafia Khatoon11Thomas Kort12James Norton13M. Madhangi14Melinda Hersey15Ann M. Greene16Filip Dubovsky17Gale Smith18Novavax, Inc.Novavax, Inc.Novavax, Inc.Novavax, Inc.Novavax, Inc.Novavax, Inc.Novavax, Inc.Novavax, Inc.Novavax, Inc.Novavax, Inc.Novavax, Inc.Novavax, Inc.Novavax, Inc.Novavax, Inc.Novavax, Inc.Novavax, Inc.Novavax, Inc.Novavax, Inc.Novavax, Inc.Abstract With the recent rise in cases of highly pathogenic avian influenza (HPAI) A(H5N1) clade 2.3.4.4b infection in humans and animals, there is an associated increase in the risk of human-to-human transmission. In this study, we characterize a recombinant A(H5N1) A/American Wigeon/South Carolina/22/000345-001/2021 (A/AW/SC/2021) clade 2.3.4.4b vaccine. Purified recombinant A/AW/SC/2021 HA trimers formulated with Matrix-M® adjuvant, saponin-cholesterol-phospholipid combination arranged in cage-like particles, are found to non-covalently anchor to the vertices of the Matrix-M and form A(H5N1) HA–Matrix-M nanoparticles (H5-MNPs). In naïve female mice, two intranasal (IN) or intramuscular (IM) doses of A/AW/SC/2021 H5-MNP vaccine induces robust antibody- and cell-mediated immune responses, including neutralizing antibodies against A(H5N1). In non-human primates (NHPs) primed with seasonal influenza vaccine, a single IM or IN dose of the A/AW/SC/2021 H5-MNP vaccine induces geometric mean serum A(H5N1) clade 2.3.4.4b pseudovirus neutralizing titers of 1:1160 and 1:54, respectively; above the generally accepted seroconverting neutralizing titer of 1:40. Immunization with H5-MNP vaccine induces antibody responses against conserved epitopes in the A(H5N1) HA stem, vestigial esterase subdomain, and receptor binding site. This A(H5N1) H5-MNP IN and IM vaccine is immunogenic in female rodents and NHPs as a potential A(H5N1) pandemic single-dose vaccine.https://doi.org/10.1038/s41467-025-61964-y
spellingShingle Nita Patel
Asma Rehman
Jessica F. Trost
Rhonda Flores
Zach Longacre
Mimi Guebre-Xabier
Haixia Zhou
Bin Zhou
Kelsey Jacobson
Desheng Jiang
Xiaoyun Bai
Rafia Khatoon
Thomas Kort
James Norton
M. Madhangi
Melinda Hersey
Ann M. Greene
Filip Dubovsky
Gale Smith
Single-dose avian influenza A(H5N1) Clade 2.3.4.4b hemagglutinin–Matrix-M® nanoparticle vaccine induces neutralizing responses in nonhuman primates
Nature Communications
title Single-dose avian influenza A(H5N1) Clade 2.3.4.4b hemagglutinin–Matrix-M® nanoparticle vaccine induces neutralizing responses in nonhuman primates
title_full Single-dose avian influenza A(H5N1) Clade 2.3.4.4b hemagglutinin–Matrix-M® nanoparticle vaccine induces neutralizing responses in nonhuman primates
title_fullStr Single-dose avian influenza A(H5N1) Clade 2.3.4.4b hemagglutinin–Matrix-M® nanoparticle vaccine induces neutralizing responses in nonhuman primates
title_full_unstemmed Single-dose avian influenza A(H5N1) Clade 2.3.4.4b hemagglutinin–Matrix-M® nanoparticle vaccine induces neutralizing responses in nonhuman primates
title_short Single-dose avian influenza A(H5N1) Clade 2.3.4.4b hemagglutinin–Matrix-M® nanoparticle vaccine induces neutralizing responses in nonhuman primates
title_sort single dose avian influenza a h5n1 clade 2 3 4 4b hemagglutinin matrix m r nanoparticle vaccine induces neutralizing responses in nonhuman primates
url https://doi.org/10.1038/s41467-025-61964-y
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