H7N9 pandemic preparedness: a large-scale production of a split inactivated vaccine

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dc.contributorLab. Bacteriologiapt_BR
dc.contributorCentro de Biotecnologiapt_BR
dc.contributorCentro Bioindustrialpt_BR
dc.contributorSeção de Vacinas Aeróbicaspt_BR
dc.contributor.authorAdami, Eduardo Alfredopt_BR
dc.contributor.authorRico, Stefanni Liliane Chavezpt_BR
dc.contributor.authorAkamatsu, Milena Apetitopt_BR
dc.contributor.authorMiyaki, Cosuept_BR
dc.contributor.authorRaw, Isaiaspt_BR
dc.contributor.authorOliveira, Dourival dept_BR
dc.contributor.authorComone, Priscilapt_BR
dc.contributor.authorOliveira, Ricardo das Nevespt_BR
dc.contributor.authorOliveira, Maria Leonor Sarno dept_BR
dc.contributor.authorAbreu, Patricia Antonia Estimapt_BR
dc.contributor.authorTakano, Carolina Yumipt_BR
dc.contributor.authorMeros, Mauriciopt_BR
dc.contributor.authorSchanoski, Alessandra Soarespt_BR
dc.contributor.authorHo, Paulo Leept_BR
dc.date.accessioned2021-02-16T13:36:31Z-
dc.date.available2021-02-16T13:36:31Z-
dc.date.issued2021pt_BR
dc.identifier.citationAdami EA, Rico SLC, Akamatsu MA, Miyaki C, Raw I, Oliveira D, et al. H7N9 pandemic preparedness: a large-scale production of a split inactivated vaccine. Biochem Biophys Res Commun. 2021 Mar;545:145-149. doi:10.1016/j.bbrc.2021.01.058.pt_BR
dc.identifier.urihttps://repositorio.butantan.gov.br/handle/butantan/3533-
dc.description.abstractIn March 2013 it was reported by the World Health Organization (WHO) the first cases of human infections with avian influenza virus A (H7N9). From 2013 to December 2019, 1568 cases have been reported with 616 deaths. H7N9 infection has been associated with high morbidity and mortality rates, and vaccination is currently the most effective way to prevent infections and consequently flu-related severe illness. Developing and producing vaccines against pandemic influenza viruses is the main strategy for a response to a possible pandemic. This study aims to present the production of three industrial lots under current Good Manufacturing Practices (cGMP) of the active antigen used to produce the pandemic influenza vaccine candidate against A(H7N9). These batches were characterized and evaluated for quality standards and tested for immunogenicity in mice. The average yield was 173.50 ± 7.88 μg/mL of hemagglutinin and all the preparations met all the required specifications. The formulated H7N9 vaccine is poorly immunogenic and needs to be adjuvanted with an oil in water emulsion adjuvant (IB160) to achieve a best immune response, in a prime and in a boost scheme. These data are important for initial production planning and preparedness in the case of a H7N9 pandemic.pt_BR
dc.description.sponsorshipFundação Butantanpt_BR
dc.description.sponsorshipFundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)pt_BR
dc.description.sponsorshipConselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq)pt_BR
dc.format.extent145-149pt_BR
dc.language.isoEnglishpt_BR
dc.relation.ispartofBiochemical and Biophysical Research Communicationspt_BR
dc.rightsOpen Accesspt_BR
dc.titleH7N9 pandemic preparedness: a large-scale production of a split inactivated vaccinept_BR
dc.typeArticlept_BR
dc.identifier.doi10.1016/j.bbrc.2021.01.058pt_BR
dc.identifier.urlhttps://doi.org/10.1016/j.bbrc.2021.01.058pt_BR
dc.identifier.citationvolume545pt_BR
dc.subject.keywordInactivated vaccinept_BR
dc.subject.keywordInfluenza vaccinept_BR
dc.subject.keywordH7N9 pandemicpt_BR
dc.subject.keywordAdjuvantpt_BR
dc.subject.keywordPandemic preparednesspt_BR
dc.relation.ispartofabbreviatedBiochem Biophys Res Communpt_BR
dc.identifier.citationabntv. 545, p. 145-149, mar. 2021pt_BR
dc.identifier.citationvancouver2021 Mar;545:145-149pt_BR
dc.contributor.butantanAdami, Eduardo Alfredo|:Técnico|:Centro Bioindustrial|:PrimeiroAutorpt_BR
dc.contributor.butantanRico, Stefanni Liliane Chavez|:Aluno|:Lab. Bacteriologiapt_BR
dc.contributor.butantanAkamatsu, Milena Apetito|:Pesquisador|:Centro Bioindustrial|:Seção de Vacinas Aeróbicaspt_BR
dc.contributor.butantanMiyaki, Cosue|:Colaborador|:Centro Bioindustrialpt_BR
dc.contributor.butantanRaw, Isaias|:Pesquisador|:Centro Bioindustrial|:Laboratório de Desenvolvimento de Vacinas (LEDV) (nome anterior|:LEDV - Laboratório de Desenvolvimento de Vacinas)pt_BR
dc.contributor.butantanOliveira, Dourival de|:Técnico|:Centro Bioindustrial|:Seção de Processamento de Plasmas Hiperimunespt_BR
dc.contributor.butantanComone, Priscila|:Técnico|:Centro Bioindustrial|:Laboratório de Influenzapt_BR
dc.contributor.butantanOliveira, Ricardo das Neves|:pt_BR
dc.contributor.butantanOliveira, Maria Leonor Sarno de|:Pesquisador|:Lab. Bacteriologiapt_BR
dc.contributor.butantanAbreu, Patricia Antonia Estima|:Pesquisador|:Lab. Bacteriologiapt_BR
dc.contributor.butantanTakano, Carolina Yumi|:Técnico|:Centro Bioindustrial|:Seção de Vacinas Aeróbicaspt_BR
dc.contributor.butantanMeros, Maurício|:Técnico|:Centro Bioindustrialpt_BR
dc.contributor.butantanSchanoski, Alessandra Soares|:Pesquisador|:Lab. Bacteriologiapt_BR
dc.contributor.butantanHo, Paulo Lee|:Pesquisador|:Centro Bioindustrial|:Autor de Correspondênciapt_BR
dc.sponsorship.butantanFundação Butantan¦¦pt_BR
dc.sponsorship.butantanFundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)¦pt_BR
dc.sponsorship.butantanConselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq)¦¦pt_BR
dc.identifier.bvsccBR78.1pt_BR
dc.identifier.bvsdbIBProdpt_BR
dc.description.dbindexedYespt_BR
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item.languageiso639-1English-
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