Production and Immune Response Against Pandemic Influenza Candidate Vaccines as Preparedness Against the Circulating H5N1 Influenza Viruses.
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Lee Ho Paulo, Medina-Armenteros Yordanka, Mendonça Munhoz Dati Lívia, Cajado-Carvalho Daniela, Savio Silva Christian, Fernandes Campos Pollyanna, Abreu Patrícia Antonia Estima, Tavares de Castro Júlia, Tonolli Paulo Newton, Fujimori Mahyumi, Silveira Martins Rosa Rhubia, Palameta Soledad, Edward Miller Michael, Sakihara Vitor Anselmo, de Lima Valadares Fernanda, Lauretti Ferreira Fabiana, Pereira Carvalho Holanda Bianca, Gonçalves de Macedo Douglas, Comone Priscila, de Souza Suffert Fogaça Natully, Bimbo Alexandre, Catanzaro De Moraes Felipe, Queiroz de Andrade Stephane Tereza, Lage Ferreira Helena, Luiz Durigon Edison, Weis Arns Clarice, George Kallás Esper, Apetito Akamatsu Milena, das Neves Oliveira Ricardo
Аннотация
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.