Immunogenicity decay and case incidence six months post Sinovac-CoronaVac vaccine in autoimmune rheumatic diseases patients
Clóvis A. Silva, Ana Cristina de Medeiros Ribeiro, Léonard de Vinci Kanda Kupa, Emily Figueiredo Neves Yuki, Sandra Gofinet Pasoto, Carla Gonçalves Schahin Saad, Solange Fusco, Rosa Maria Rodrigues Pereira, Samuel Katsuyuki Shinjo, Ari Stiel Radu Halpern, Eduardo Ferreira Borba, Fernando Henrique Carlos de Souza, Lissiane Karine Noronha Guedes, Renata Miossi, Karina Rossi Bonfiglioli, Diogo Souza Domiciano, Andrea Yukie Shimabuco, Danieli Andrade, Luciana Parente Costa Seguro, Ricardo Fuller, Percival D. Sampaio‐Barros, Ana Paula Luppino Assad, Júlio César Bertacini de Moraes, Cláudia Goldenstein‐Schainberg, Henrique A. M. Giardini, Henrique C. Silva, Victor A. O. Martins, Lorena Elizabeth Betancourt Villamarín, Renata Soares, Lucas Peixoto Sales, Carlo Scognamiglio Renner Araújo, Matheus S.R. Silva, Dilson M. N. Filho, Marta Heloísa Lopes, Alberto J. S. Duarte, Esper G. Kallás, Nádia Emi Aikawa, Eloísa Bonfá
Abstract
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).