An open-label randomized controlled parallel-group pilot study comparing the immunogenicity of a standard-, double- and booster-dose regimens of the 2014 seasonal trivalent inactivated influenza vaccine in kidney transplant recipients

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dc.contributorCentro de Ensaios Clínicos e Farmacovigilânciapt_BR
dc.contributor.authorOdongo, Fatuma Catherine Atienopt_BR
dc.contributor.authorBraga, Patrícia Emíliapt_BR
dc.contributor.authorPalacios, Ricardopt_BR
dc.contributor.authorMiraglia, João Luizpt_BR
dc.contributor.authorSartori, Ana Marli Christovampt_BR
dc.contributor.authorIbrahim, Karim Yaqubpt_BR
dc.contributor.authorLopes, Marta Heloisapt_BR
dc.contributor.authorCaiaffa-Filho, Helio Hehlpt_BR
dc.contributor.authorTimenetsky, Maria do Carmo Sampaio Tavarespt_BR
dc.contributor.authorAgena, Fabianapt_BR
dc.contributor.authorde Azevedo, Luiz Sergio Fonsecapt_BR
dc.contributor.authorDavid-Neto, Eliaspt_BR
dc.contributor.authorPrecioso, Alexander Robertopt_BR
dc.contributor.authorPierrotti, Lígia Camerapt_BR
dc.date.accessioned2021-05-21T18:00:32Z-
dc.date.available2021-05-21T18:00:32Z-
dc.date.issued2021pt_BR
dc.identifier.citationOdongo FCA, Braga PE, Palacios R, Miraglia JL, Sartori AMC, Ibrahim KY, et al. An open-label randomized controlled parallel-group pilot study comparing the immunogenicity of a standard-, double- and booster-dose regimens of the 2014 seasonal trivalent inactivated influenza vaccine in kidney transplant recipients. Transplantation. 2021 Feb;in press. doi:10.1097/TP.0000000000003702.pt_BR
dc.identifier.urihttps://repositorio.butantan.gov.br/handle/butantan/3764-
dc.description.abstractBackground: Immunogenicity of influenza vaccine in transplant recipients is suboptimal and alternative vaccination regimens are necessary. Methods: We compared the immunogenicity of a standard-dose trivalent inactivated influenza vaccination (SDTIIV), double-dose trivalent inactivated influenza vaccination (DDTIIV) and booster-dose trivalent inactivated influenza vaccination (BDTIIV) of the 2014 seasonal trivalent inactivated influenza vaccine in kidney transplant recipients. We randomized 176 participants to SDTIIV (59), DDTIIV (59) and BDTIIV regimens (58). Antibody titres were determined by hemagglutination inhibition at enrollment and 21 days post-vaccination. Seroprotection rates (SPR), seroconversion rates (SCR) and geometric mean ratios (GMR) were analyzed separately for participants with low (<1:40) and high (≥1:40) pre-vaccination antibody titres. Results: Vaccination was confirmed for 172 participants. Immunogenicity analysis was done for 149 participants who provided post-vaccination blood samples. In the subgroup with high pre-vaccination antibody titres, all vaccination regimens induced SPR >70% to all antigens, but SCR and GMR were below the recommendations. In the subgroup with low pre-vaccination antibody titres, DDTIIV and BDTIIV regimens induced adequate SCR >40% and GMR >2,5 for all antigens, while SDTIIV achieved the same outcomes only for influenza B. SPR were >70% only after DDTIIV (A/H1N1 - 77.8%) and BDTIIV (A/H3N2 - 77.8%). BDTIIV regimen independently increased seroprotection to A/H1N1 (PR=2.58; p=0.021) and A/H3N2 (PR=2.21; p=0.004), while DDTIIV independently increased seroprotection to A/H1N1 (PR=2.59; p=0.021). Conclusion: Our results suggest that DDTIIV and BDTIIV regimens are more immunogenic than SDTIIV, indicating the need for head-to-head multicenter clinical trials to further evaluate their efficacy.pt_BR
dc.language.isoEnglishpt_BR
dc.relation.ispartofTransplantationpt_BR
dc.rightsOpen Accesspt_BR
dc.titleAn open-label randomized controlled parallel-group pilot study comparing the immunogenicity of a standard-, double- and booster-dose regimens of the 2014 seasonal trivalent inactivated influenza vaccine in kidney transplant recipientspt_BR
dc.typeArticlept_BR
dc.identifier.doi10.1097/TP.0000000000003702pt_BR
dc.identifier.urlhttps://doi.org/10.1097/TP.0000000000003702pt_BR
dc.contributor.externalUniversidade de São Paulo (USP)pt_BR
dc.contributor.externalInstituto Adolfo Lutz (IAL)pt_BR
dc.relation.ispartofabbreviatedTransplantationpt_BR
dc.identifier.citationabntin press, fev. 2021pt_BR
dc.identifier.citationvancouver2021 Feb;in presspt_BR
dc.contributor.butantanBraga, Patrícia Emília|:Pesquisador|:Centro de Ensaios Clínicos e Farmacovigilânciapt_BR
dc.contributor.butantanPalacios, Ricardo|:Pesquisador|:Centro de Ensaios Clínicos e Farmacovigilânciapt_BR
dc.contributor.butantanMiraglia, João Luiz|:Colaborador|:Centro de Ensaios Clínicos e Farmacovigilânciapt_BR
dc.contributor.butantanPrecioso, Alexander Roberto|:Pesquisador|:Centro de Ensaios Clínicos e Farmacovigilânciapt_BR
dc.identifier.bvsccBR78.1pt_BR
dc.identifier.bvsdbIBProdpt_BR
dc.description.dbindexedYespt_BR
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