Systemic autoimmune myopathies: a prospective phase 4 controlled trial of an inactivated virus vaccine against SARS-CoV-2

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Shinjo, Samuel K. ; de Souza, Fernando H. C. ; Borges, Isabela B. P. ; Dos Santos, Alexandre M. ; Miossi, Renata ; Misse, Rafael G. ; Medeiros-Ribeiro, Ana C. ; Saad, Carla G. S. ; Yuki, Emily F. N. ; Pasoto, Sandra G. ; Kupa, Leonard V. K. ; Ceneviva, Carina ; Seraphim, Julia C. ; Pedrosa, Tatiana N. ; Vendramini, Margarete B. G. ; Silva, Clovis A. ; Aikawa, Nadia E. ; Bonfa, Eloisa

• Document type: Journal article
• Source: RHEUMATOLOGY; v. N/A, p. 11-pg., 2021-10-19.

Abstract

Objectives. To evaluate immunogenicity and safety of an inactivated SARS-CoV-2 vaccine in systemic autoimmune myopathies (SAMs) and the possible influence of baseline disease parameters, comorbidities and therapy on immune response. Methods. This prospective controlled study included 53 patients with SAMs and 106 non-immunocompromised control group (CTRL). All participants received two doses of the Sinovac-CoronaVac vaccine (28-day interval). Immunogenicity was assessed by anti-SARS-CoV-2 S1/S2 IgG seroconversion (SC), anti-S1/S2 IgG geometric mean titre (GMT), factor increase GMT (FI-GMT), neutralizing antibodies (NAb) positivity, and median neutralizing activity after each vaccine dose (D0 and D28) and six weeks after the second dose (D69). Participants with pre-vaccination positive IgG serology and/or NAb and those with RT-PCR confirmed COVID-19 during the protocol were excluded from immunogenicity analysis. Results. Patients and CTRL had comparable sex (P>0.99) and age (P=0.90). Immunogenicity of 37 patients and 79 CTRL-naive participants revealed at D69, a moderate but significantly lower SC (64.9% vs 91.1%, P<0.001), GMT [7.9 (95%CI 4.7-13.2) vs 24.7 (95%CI 30.0-30.5) UA/ml, P<0.001] and frequency of NAb (51.4% vs 77.2%, P<0.001) in SAMs compared with CTRL. Median neutralizing activity was comparable in both groups [57.2% (interquartile range (IQR) 43.4-83.4) vs 63.0% (IQR 40.3-80.7), P=0.808]. Immunosuppressives were less frequently used among NAb+ patients vs NAb- patients (73.7% vs 100%, P=0.046). Type of SAMs, disease status, other drugs or comorbidities did not influence immunogenicity. Vaccine-related adverse events were mild with similar frequencies in patients and CTRL (P>0.05). Conclusion. Sinovac-CoronaVac is safe and has a moderate short-term immunogenicity in SAMs, but reduced compared with CTRL. We further identified that immunosuppression is associated with diminished NAb positivity. (AU)

• 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: 19/21211-6 - Salivary hydroxychloroquine levels: relevance in juvenile systemic lupus erythematosus (JSLE) disease activity and renal disease activity in adult systemic lupus erythematosus
• Grantee: Júlia Celestino Seraphim
• Support Opportunities: Scholarships in Brazil - Scientific Initiation
• FAPESP's process: 19/11776-6 - Impact and safety of noninvasive cerebral neuromodulation in patients with systemic autoimmune diseases: double-blind, randomized, placebo-controlled study
• Grantee: Samuel Katsuyuki Shinjo
• Support Opportunities: Regular Research Grants
• 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