针对大流行性流感候选疫苗的生产及免疫反应，作为应对正在传播的H5N1流感病毒的防范措施。

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

作者信息

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

机构信息

BioIndustrial Center, Butantan Institute and Butantan Foundation, São Paulo 05503-900, SP, Brazil.

Institute of Biology, University of Campinas, Campinas 13083-862, SP, Brazil.

出版信息

Vaccines (Basel). 2025 Jun 8;13(6):620. doi: 10.3390/vaccines13060620.

DOI:10.3390/vaccines13060620

PMID:40573951

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12197369/

Abstract

UNLABELLED

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.

摘要

未标注

H5N1流感病毒正在全球传播，威胁着全球公共卫生。有必要做好准备，以减轻H5N1流感大流行可能出现的最坏情况，并为研发针对令人担忧的流行H5N1病毒的疫苗提供依据。

方法

在工业规模上生产并鉴定了来自2.3.4.4b、2.3.2.1c和2.3.4分支的三种不同单价抗原的基于鸡蛋的裂解和灭活H5Nx。将这些抗原进行配方，并在大鼠模型中评估其在单剂量或双剂量免疫方案中与基于IB160角鲨烯的水包油乳液佐剂联合或不联合时的免疫反应。测量了IgG抗体、血凝抑制和微量中和效价，以评估疫苗诱导的免疫和交叉反应性。