Production and Immune Response Against Pandemic Influenza Candidate Vaccines as Preparedness Against the Circulating H5N1 Influenza Viruses

<b>Background/Objectives:</b>H5N1 influenza viruses are spreading worldwide and threaten global public health. Preparedness is necessary to mitigate the worst-case scenario should an H5N1 influenza pandemic occur and justify the development of vaccines against circulating H5N1 viruses of...

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Main Authors: Paulo Lee Ho, Yordanka Medina-Armenteros, Lívia Mendonça Munhoz Dati, Daniela Cajado-Carvalho, Christian Savio Silva, Pollyanna Fernandes Campos, Patrícia Antonia Estima Abreu, Júlia Tavares de Castro, Paulo Newton Tonolli, Mahyumi Fujimori, Rhubia Silveira Martins Rosa, Soledad Palameta, Michael Edward Miller, Vitor Anselmo Sakihara, Fernanda de Lima Valadares, Fabiana Lauretti Ferreira, Bianca Pereira Carvalho Holanda, Douglas Gonçalves de Macedo, Priscila Comone, Natully de Souza Suffert Fogaça, Alexandre Bimbo, Felipe Catanzaro De Moraes, Stephane Tereza Queiroz de Andrade, Helena Lage Ferreira, Edison Luiz Durigon, Clarice Weis Arns, Esper George Kallás, Milena Apetito Akamatsu, Ricardo das Neves Oliveira
Format: Article
Language:English
Published: MDPI AG 2025-06-01
Series:Vaccines
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Online Access:https://www.mdpi.com/2076-393X/13/6/620
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author Paulo Lee Ho
Yordanka Medina-Armenteros
Lívia Mendonça Munhoz Dati
Daniela Cajado-Carvalho
Christian Savio Silva
Pollyanna Fernandes Campos
Patrícia Antonia Estima Abreu
Júlia Tavares de Castro
Paulo Newton Tonolli
Mahyumi Fujimori
Rhubia Silveira Martins Rosa
Soledad Palameta
Michael Edward Miller
Vitor Anselmo Sakihara
Fernanda de Lima Valadares
Fabiana Lauretti Ferreira
Bianca Pereira Carvalho Holanda
Douglas Gonçalves de Macedo
Priscila Comone
Natully de Souza Suffert Fogaça
Alexandre Bimbo
Felipe Catanzaro De Moraes
Stephane Tereza Queiroz de Andrade
Helena Lage Ferreira
Edison Luiz Durigon
Clarice Weis Arns
Esper George Kallás
Milena Apetito Akamatsu
Ricardo das Neves Oliveira
author_facet Paulo Lee Ho
Yordanka Medina-Armenteros
Lívia Mendonça Munhoz Dati
Daniela Cajado-Carvalho
Christian Savio Silva
Pollyanna Fernandes Campos
Patrícia Antonia Estima Abreu
Júlia Tavares de Castro
Paulo Newton Tonolli
Mahyumi Fujimori
Rhubia Silveira Martins Rosa
Soledad Palameta
Michael Edward Miller
Vitor Anselmo Sakihara
Fernanda de Lima Valadares
Fabiana Lauretti Ferreira
Bianca Pereira Carvalho Holanda
Douglas Gonçalves de Macedo
Priscila Comone
Natully de Souza Suffert Fogaça
Alexandre Bimbo
Felipe Catanzaro De Moraes
Stephane Tereza Queiroz de Andrade
Helena Lage Ferreira
Edison Luiz Durigon
Clarice Weis Arns
Esper George Kallás
Milena Apetito Akamatsu
Ricardo das Neves Oliveira
author_sort Paulo Lee Ho
collection DOAJ
description <b>Background/Objectives:</b>H5N1 influenza viruses are spreading worldwide and threaten global public health. Preparedness is necessary to mitigate the worst-case scenario should an H5N1 influenza pandemic occur and justify the development of vaccines against circulating H5N1 viruses of concern. Methods: The production and characterization of egg-based split and inactivated H5Nx of three distinct monovalent antigens from clades 2.3.4.4b, 2.3.2.1c, and 2.3.4 were performed at an industrial scale. These antigens were formulated and their immune responses, when combined or not with IB160 squalene-based oil-in-water emulsion adjuvant in a rat model, were evaluated in a one- or two-dose immunization schedule. IgG antibodies, hemagglutination inhibitions, and microneutralization titers were measured for vaccine-induced immunity and cross-reactivity. Results: Three monovalent vaccines from clades 2.3.4.4b, 2.3.2.1c, and 2.3.4 were produced at an industrial scale and characterized. The immune responses against the monovalent vaccines showed a clade-specific antibody response and the need to combine with IB160 adjuvant for a required immune response. Conclusions: Considering the candidate vaccine viruses (CVVs) with the testing potency reagents available and that the antibody response obtained against the CVVs produced was clade-specific, IDCDC RG-71A is the indicated CVV for the predominant currently circulating H5N1 influenza virus of clade 2.3.4.4b and must be combined with adjuvant to induce a higher and efficacious immune response in a two-dose immunization protocol.
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spelling doaj-art-ffe2ecaefd9c48c3b2356306b72afab42025-08-20T02:21:58ZengMDPI AGVaccines2076-393X2025-06-0113662010.3390/vaccines13060620Production and Immune Response Against Pandemic Influenza Candidate Vaccines as Preparedness Against the Circulating H5N1 Influenza VirusesPaulo Lee Ho0Yordanka Medina-Armenteros1Lívia Mendonça Munhoz Dati2Daniela Cajado-Carvalho3Christian Savio Silva4Pollyanna Fernandes Campos5Patrícia Antonia Estima Abreu6Júlia Tavares de Castro7Paulo Newton Tonolli8Mahyumi Fujimori9Rhubia Silveira Martins Rosa10Soledad Palameta11Michael Edward Miller12Vitor Anselmo Sakihara13Fernanda de Lima Valadares14Fabiana Lauretti Ferreira15Bianca Pereira Carvalho Holanda16Douglas Gonçalves de Macedo17Priscila Comone18Natully de Souza Suffert Fogaça19Alexandre Bimbo20Felipe Catanzaro De Moraes21Stephane Tereza Queiroz de Andrade22Helena Lage Ferreira23Edison Luiz Durigon24Clarice Weis Arns25Esper George Kallás26Milena Apetito Akamatsu27Ricardo das Neves Oliveira28BioIndustrial Center, Butantan Institute and Butantan Foundation, São Paulo 05503-900, SP, BrazilBioIndustrial Center, Butantan Institute and Butantan Foundation, São Paulo 05503-900, SP, BrazilBioIndustrial Center, Butantan Institute and Butantan Foundation, São Paulo 05503-900, SP, BrazilBioIndustrial Center, Butantan Institute and Butantan Foundation, São Paulo 05503-900, SP, BrazilBioIndustrial Center, Butantan Institute and Butantan Foundation, São Paulo 05503-900, SP, BrazilBioIndustrial Center, Butantan Institute and Butantan Foundation, São Paulo 05503-900, SP, BrazilBioIndustrial Center, Butantan Institute and Butantan Foundation, São Paulo 05503-900, SP, BrazilBioIndustrial Center, Butantan Institute and Butantan Foundation, São Paulo 05503-900, SP, BrazilBioIndustrial Center, Butantan Institute and Butantan Foundation, São Paulo 05503-900, SP, BrazilBioIndustrial Center, Butantan Institute and Butantan Foundation, São Paulo 05503-900, SP, BrazilInstitute of Biology, University of Campinas, Campinas 13083-862, SP, BrazilInstitute of Biology, University of Campinas, Campinas 13083-862, SP, BrazilInstitute of Biology, University of Campinas, Campinas 13083-862, SP, BrazilBioIndustrial Center, Butantan Institute and Butantan Foundation, São Paulo 05503-900, SP, BrazilBioIndustrial Center, Butantan Institute and Butantan Foundation, São Paulo 05503-900, SP, BrazilBioIndustrial Center, Butantan Institute and Butantan Foundation, São Paulo 05503-900, SP, BrazilBioIndustrial Center, Butantan Institute and Butantan Foundation, São Paulo 05503-900, SP, BrazilBioIndustrial Center, Butantan Institute and Butantan Foundation, São Paulo 05503-900, SP, BrazilBioIndustrial Center, Butantan Institute and Butantan Foundation, São Paulo 05503-900, SP, BrazilBioIndustrial Center, Butantan Institute and Butantan Foundation, São Paulo 05503-900, SP, BrazilBioIndustrial Center, Butantan Institute and Butantan Foundation, São Paulo 05503-900, SP, BrazilBioIndustrial Center, Butantan Institute and Butantan Foundation, São Paulo 05503-900, SP, BrazilBioIndustrial Center, Butantan Institute and Butantan Foundation, São Paulo 05503-900, SP, BrazilFaculdade de Zootecnia e Engenharia de Alimentos, Universidade de São Paulo, Pirassununga 13635-900, SP, BrazilInstituto de Ciências Biomédicas, Universidade de São Paulo, São Paulo 05508-000, SP, BrazilInstitute of Biology, University of Campinas, Campinas 13083-862, SP, BrazilBioIndustrial Center, Butantan Institute and Butantan Foundation, São Paulo 05503-900, SP, BrazilBioIndustrial Center, Butantan Institute and Butantan Foundation, São Paulo 05503-900, SP, BrazilBioIndustrial Center, Butantan Institute and Butantan Foundation, São Paulo 05503-900, SP, Brazil<b>Background/Objectives:</b>H5N1 influenza viruses are spreading worldwide and threaten global public health. Preparedness is necessary to mitigate the worst-case scenario should an H5N1 influenza pandemic occur and justify the development of vaccines against circulating H5N1 viruses of concern. Methods: The production and characterization of egg-based split and inactivated H5Nx of three distinct monovalent antigens from clades 2.3.4.4b, 2.3.2.1c, and 2.3.4 were performed at an industrial scale. These antigens were formulated and their immune responses, when combined or not with IB160 squalene-based oil-in-water emulsion adjuvant in a rat model, were evaluated in a one- or two-dose immunization schedule. IgG antibodies, hemagglutination inhibitions, and microneutralization titers were measured for vaccine-induced immunity and cross-reactivity. Results: Three monovalent vaccines from clades 2.3.4.4b, 2.3.2.1c, and 2.3.4 were produced at an industrial scale and characterized. The immune responses against the monovalent vaccines showed a clade-specific antibody response and the need to combine with IB160 adjuvant for a required immune response. Conclusions: Considering the candidate vaccine viruses (CVVs) with the testing potency reagents available and that the antibody response obtained against the CVVs produced was clade-specific, IDCDC RG-71A is the indicated CVV for the predominant currently circulating H5N1 influenza virus of clade 2.3.4.4b and must be combined with adjuvant to induce a higher and efficacious immune response in a two-dose immunization protocol.https://www.mdpi.com/2076-393X/13/6/620influenza virusH5N1 pandemic influenza vaccinesqualene-based emulsion adjuvantimmunogenicityhemagglutination inhibitionmicroneutralization
spellingShingle Paulo Lee Ho
Yordanka Medina-Armenteros
Lívia Mendonça Munhoz Dati
Daniela Cajado-Carvalho
Christian Savio Silva
Pollyanna Fernandes Campos
Patrícia Antonia Estima Abreu
Júlia Tavares de Castro
Paulo Newton Tonolli
Mahyumi Fujimori
Rhubia Silveira Martins Rosa
Soledad Palameta
Michael Edward Miller
Vitor Anselmo Sakihara
Fernanda de Lima Valadares
Fabiana Lauretti Ferreira
Bianca Pereira Carvalho Holanda
Douglas Gonçalves de Macedo
Priscila Comone
Natully de Souza Suffert Fogaça
Alexandre Bimbo
Felipe Catanzaro De Moraes
Stephane Tereza Queiroz de Andrade
Helena Lage Ferreira
Edison Luiz Durigon
Clarice Weis Arns
Esper George Kallás
Milena Apetito Akamatsu
Ricardo das Neves Oliveira
Production and Immune Response Against Pandemic Influenza Candidate Vaccines as Preparedness Against the Circulating H5N1 Influenza Viruses
Vaccines
influenza virus
H5N1 pandemic influenza vaccine
squalene-based emulsion adjuvant
immunogenicity
hemagglutination inhibition
microneutralization
title Production and Immune Response Against Pandemic Influenza Candidate Vaccines as Preparedness Against the Circulating H5N1 Influenza Viruses
title_full Production and Immune Response Against Pandemic Influenza Candidate Vaccines as Preparedness Against the Circulating H5N1 Influenza Viruses
title_fullStr Production and Immune Response Against Pandemic Influenza Candidate Vaccines as Preparedness Against the Circulating H5N1 Influenza Viruses
title_full_unstemmed Production and Immune Response Against Pandemic Influenza Candidate Vaccines as Preparedness Against the Circulating H5N1 Influenza Viruses
title_short Production and Immune Response Against Pandemic Influenza Candidate Vaccines as Preparedness Against the Circulating H5N1 Influenza Viruses
title_sort production and immune response against pandemic influenza candidate vaccines as preparedness against the circulating h5n1 influenza viruses
topic influenza virus
H5N1 pandemic influenza vaccine
squalene-based emulsion adjuvant
immunogenicity
hemagglutination inhibition
microneutralization
url https://www.mdpi.com/2076-393X/13/6/620
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