Immunogenicity decay and case incidence six months post Sinovac-CoronaVac vaccine in autoimmune rheumatic diseases patients

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Silva, Clovis A. ; Medeiros-Ribeiro, Ana C. ; Kupa, Leonard V. K. ; Yuki, Emily F. N. ; Pasoto, Sandra G. ; Saad, Carla G. S. ; Fusco, Solange R. G. ; Pereira, Rosa M. R. ; Shinjo, Samuel K. ; Halpern, Ari S. R. ; Borba, Eduardo F. ; Souza, Fernando H. C. ; Guedes, Lissiane K. N. ; Miossi, Renata ; Bonfiglioli, Karina R. ; Domiciano, Diogo S. ; Shimabuco, Andrea Y. ; Andrade, Danieli C. O. ; Seguro, Luciana P. C. ; Fuller, Ricardo ; Sampaio-Barros, Percival D. ; Assad, Ana P. L. ; Moraes, Julio C. B. ; Goldenstein-Schainberg, Claudia ; Giardini, Henrique A. M. ; Silva, Henrique C. ; Martins, Victor A. O. ; Villamarin, Lorena E. B. ; Novellino, Renata S. ; Sales, Lucas P. ; Araujo, Carlo S. R. ; Silva, Matheus S. R. ; Filho, Dilson M. N. ; Lopes, Marta H. ; Duarte, Alberto J. S. ; Kallas, Esper G. ; Aikawa, Nadia E. ; Bonfa, Eloisa

• Document type: Journal article
• Source: NATURE COMMUNICATIONS; v. 13, n. 1, p. 9-pg., 2022-10-03.

Abstract

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)

• FAPESP's process: 15/03756-4 - Assessment of relevance of blood levels of drugs in the monitoring rheumatic autoimmune diseases: safety, effectiveness and adherence to therapy
• Grantee: Eloisa Silva Dutra de Oliveira Bonfá
• Support Opportunities: Research Projects - Thematic Grants
• FAPESP's process: 18/09937-9 - Analysis of the immune profile of saliva and serum of patients with primary Sjogren's Syndrome
• Grantee: Victor Adriano de Oliveira Martins
• Support Opportunities: Scholarships in Brazil - Doctorate (Direct)
• FAPESP's process: 20/09367-8 - Analysis of blood hydroxychlorochine levels in patients with primary Sjogren Syndrome and possible correlation with the disease activity
• Grantee: Lorena Elizabeth Betancourt Villamarín
• Support Opportunities: Scholarships in Brazil - Doctorate (Direct)
• FAPESP's process: 19/17272-0 - Relevance of monitoring blood levels compared to salivar levels of drugs used in rheumatic autoimmune diseases: adherence and understanding the possible underlying mechanisms involved in effectiveness and in adverse effects
• Grantee: Leonard de Vinci Kanda Kupa
• Support Opportunities: Scholarships in Brazil - Post-Doctoral