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

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
Subjects:
influenza virus
H5N1 pandemic influenza vaccine
squalene-based emulsion adjuvant
immunogenicity
hemagglutination inhibition
microneutralization
Online Access:https://www.mdpi.com/2076-393X/13/6/620
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Summary:<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.
ISSN:2076-393X

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