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| Autor(es): Mostrar menos - |
Silva, Clovis A.
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Medeiros-Ribeiro, Ana C.
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Kupa, Leonard V. K.
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Yuki, Emily F. N.
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Pasoto, Sandra G.
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Saad, Carla G. S.
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Fusco, Solange R. G.
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Pereira, Rosa M. R.
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Shinjo, Samuel K.
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Halpern, Ari S. R.
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Borba, Eduardo F.
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Souza, Fernando H. C.
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Guedes, Lissiane K. N.
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Miossi, Renata
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Bonfiglioli, Karina R.
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Domiciano, Diogo S.
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Shimabuco, Andrea Y.
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Andrade, Danieli C. O.
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Seguro, Luciana P. C.
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Fuller, Ricardo
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Sampaio-Barros, Percival D.
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Assad, Ana P. L.
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Moraes, Julio C. B.
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Goldenstein-Schainberg, Claudia
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Giardini, Henrique A. M.
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Silva, Henrique C.
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Martins, Victor A. O.
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Villamarin, Lorena E. B.
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Novellino, Renata S.
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Sales, Lucas P.
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Araujo, Carlo S. R.
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Silva, Matheus S. R.
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Filho, Dilson M. N.
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Lopes, Marta H.
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Duarte, Alberto J. S.
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Kallas, Esper G.
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Aikawa, Nadia E.
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Bonfa, Eloisa
Número total de Autores: 38
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| Tipo de documento: | Artigo Científico |
| Fonte: | NATURE COMMUNICATIONS; v. 13, n. 1, p. 9-pg., 2022-10-03. |
| Resumo | |
Characterising the response to SARS-CoV-2 post vaccination is critical in the appraisement of the induced immune response, performance and protective potential. Here the authors present data from a phase 4 clinical trial in autoimmune rheumatic disease patients 6 months post second dose of Sinovac-CoronaVac inactivated vaccine that show a marked reduction in antibody particularly in males or those under treatment with immune targeting therapies but saw no rise in COVID-19 disease. The determination of durability and vaccine-associated protection is essential for booster doses strategies, however data on the stability of SARS-CoV-2 immunity are scarce. Here we assess anti-SARS-CoV-2 immunogenicity decay and incident cases six months after the 2(nd) dose of Sinovac-CoronaVac inactivated vaccine (D210) in 828 autoimmune rheumatic diseases patients compared with 207 age/sex-balanced control individuals. The primary outcome is the presence of anti-S1/S2 SARS-CoV-2 IgG at 6 months compared to 6 weeks after 2nd vaccine dose for decay evaluation. Secondary outcomes are presence of neutralizing antibodies, percent inhibition by neutralizing, geometric mean titers and cumulative incident cases at 6 months after 2nd dose. Anti-S1/S2 IgG positivity and titers reduce to 23.8% and 38% in patients (p < 0.001) during the six-month follow up and 20% and 51% in controls (p < 0.001), respectively. Neutralizing antibodies positivity and percent inhibition declines 41% and 54% in patients (p < 0.001) and 39.7% and 47% in controls (p < 0.001). Multivariate logistic regression analysis show males (OR = 0.56;95% CI0.40-0.79), prednisone (OR = 0.56; 95% CI0.41-0.76), anti-TNF (OR = 0.66;95% CI0.45-0.96), abatacept (OR = 0.29; 95% CI0.15-0.56) and rituximab (OR = 0.32;95% CI0.11-0.90) associate with a substantial reduction in IgG response at day 210 in patients. Although cellular immunity was not assessed, a decrease of COVID-19 cases (from 27.5 to 8.1/100 person-years; p < 0.001) is observed despite the concomitant emergence and spread of the Delta variant. Altogether we show a reduction in immunity 6-months of Sinovac-CoronaVac 2nd dose, particularly in males and those under immunosuppressives therapies, without a concomitant rise in COVID-19 cases. (CoronavRheum clinicaltrials.gov:NCT04754698). (AU) | |
| Processo FAPESP: | 15/03756-4 - Avaliação da relevância dos níveis sanguíneos de drogas utilizadas em doenças autoimunes reumatológicas no acompanhamento da segurança, eficácia e aderência à terapêutica |
| Beneficiário: | Eloisa Silva Dutra de Oliveira Bonfá |
| Modalidade de apoio: | Auxílio à Pesquisa - Temático |
| Processo FAPESP: | 18/09937-9 - Análise do perfil imune da saliva e soro dos pacientes com Síndrome de Sjogren primária |
| Beneficiário: | Victor Adriano de Oliveira Martins |
| Modalidade de apoio: | Bolsas no Brasil - Doutorado Direto |
| Processo FAPESP: | 20/09367-8 - Análise dos níveis sanguíneos de hidroxicloroquina em pacientes com Síndrome de Sjogren primária e sua possível correlação com a atividade de doença |
| Beneficiário: | Lorena Elizabeth Betancourt Villamarín |
| Modalidade de apoio: | Bolsas no Brasil - Doutorado Direto |
| Processo FAPESP: | 19/17272-0 - Avaliação da relevância dos níveis sanguíneos de drogas utilizadas em doenças autoimunes reumatológicas no acompanhamento da segurança, eficácia e aderência à terapêutica |
| Beneficiário: | Leonard de Vinci Kanda Kupa |
| Modalidade de apoio: | Bolsas no Brasil - Pós-Doutorado |