Inactivated SARS-CoV-2 vaccine in primary Sjogren's syndrome: humoral response, safety, and effects on disease activity

Author(s):Show less -

Pasoto, Sandra Gofinet ; Halpern, Ari Stiel Radu ; Noronha Guedes, Lissiane Karine ; Medeiros Ribeiro, Ana Cristina ; Figueiredo Yuki, Emily Neves ; Schahin Saad, Carla Goncalves ; Almeida da Silva, Clovis Artur ; Kanda Kupa, Leonard de Vinci ; Betancourt Villamarin, Lorena Elizabeth ; de Oliveira Martins, Victor Adriano ; Machado Freire Martins, Carolina Campagnoli ; Henriques Deveza, Giordano Bruno ; Leon, Elaine Pires ; Bueno, Cleonice ; Pedrosa, Tatiana Nascimento ; Beseggio Santos, Roseli Eliana ; Soares, Renata ; Aikawa, Nadia Emi ; Bonfa, Eloisa

• Document type: Journal article
• Source: CLINICAL RHEUMATOLOGY; v. 41, n. 7, p. 11-pg., 2022-03-19.

Abstract

Introduction There is no study specifically focused on SARS-CoV-2 vaccine in primary Sjogren's syndrome (pSS). Objectives To assess the immunogenicity, safety, possible effects on disease activity, and autoantibody profile of the Sinovac-CoronaVac vaccine in pSS. Methods Fifty-one pSS patients and 102 sex- and age-balanced controls without autoimmune diseases were included in a prospective phase 4 trial of the Sinovac-CoronaVac vaccine (two doses 28 days apart, D0/D28). Participants were assessed in three face-to-face visits (D0/D28 and six weeks after the 2nd dose (D69)) regarding adverse effects; clinical EULAR Sjogren's Syndrome Disease Activity Index (clinESSDAI); anti-SARS-CoV-2 S1/S2 IgG (seroconversion (SC) and geometric mean titers (GMT)); neutralizing antibodies (NAb); and pSS autoantibody profile. Results Patients and controls had comparable female sex frequency (98.0% vs. 98.0%, p= 1.000) and mean age (53.5 +11.7 vs. 53.4 +11.4 years, p= 0.924), respectively. On D69, pSS patients presented moderate SC (67.5% vs. 93.0%, p< 0.001) and GMT (22.5 (95% CI 14.6-34.5) vs. 59.6 (95% CI 51.1-69.4) AU/mL, p< 0.001) of anti-SARS-CoV-2 S1/S2 IgG but lower than controls, and also, moderate NAb frequency (52.5% vs. 73.3%, p= 0.021) but lower than controls. Median neutralizing activity on D69 was comparable in pSS (58.6% (IQR 43.7-63.6)) and controls (64% (IQR 46.4-81.1)) (p= 0.219). Adverse events were mild. clinESSDAI and anti-Ro(SS-A)/anti-La(SS-B) levels were stable throughout the study (p> 0.05). Conclusion Sinovac-CoronaVac vaccine is safe in pSS, without a deleterious impact on disease activity, and has a moderate short-term humoral response, though lower than controls. Thus, a booster dose needs to be studied in these patients. (AU)

• FAPESP's process: 20/11677-5 - Analysis of the immune profile of saliva and serum of patients with primary Sjögren's Syndrome
• Grantee: Giordano Bruno Henriques Deveza
• Support Opportunities: Scholarships in Brazil - Scientific Initiation
• 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
• FAPESP's process: 17/14352-7 - Assessment of relevance of blood levels of drugs in the monitoring rheumatic autoimmune diseases: safety, effectiveness and adherence to therapy
• Grantee: Tatiana Do Nascimento Pedrosa
• Support Opportunities: Scholarships in Brazil - Post-Doctoral
• 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: 21/08455-3 - Immunogenicity and safety of Coronavac vaccine in patients with autoimmune rheumatologic diseases: primary Sjörgren syndrome
• Grantee: Carolina Campagnoli Machado Freire Martins
• Support Opportunities: Scholarships in Brazil - Scientific Initiation