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

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

doi:10.1093/rheumatology/keab773

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

Rheumatology (Oxford). 2022 Aug 3;61(8):3351-3361. doi: 10.1093/rheumatology/keab773.

Authors

Samuel K Shinjo¹, Fernando H C de Souza¹, Isabela B P Borges¹, Alexandre M Dos Santos¹, Renata Miossi¹, Rafael G Misse¹, Ana C Medeiros-Ribeiro¹, Carla G S Saad¹, Emily F N Yuki¹, Sandra G Pasoto¹, Léonard V K Kupa¹, Carina Ceneviva², Júlia C Seraphim¹, Tatiana N Pedrosa¹, Margarete B G Vendramini¹, Clóvis A Silva³, Nádia E Aikawa^{1

3}, Eloisa Bonfá¹

Affiliations

¹ Division of Rheumatology.
² Central Laboratory Division.
³ Pediatric Rheumatology Unit, Childrens' Institute, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, SP, Brazil (BR).

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-naïve 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.

Trial registration: COVID-19 CoronaVac in Patients With Autoimmune Rheumatic Diseases and HIV/AIDS (CoronavRheum), http://clinicaltrials.gov/ct2/show/NCT04754698.

Keywords: COVID-19; anti-SARS-CoV-2 vaccine; immunogenicity; myositis; neutralizing antibodies; safety.

Publication types

Clinical Trial, Phase IV
Controlled Clinical Trial
Research Support, Non-U.S. Gov't

MeSH terms

Antibodies, Neutralizing
Antibodies, Viral
Autoimmune Diseases* / drug therapy
COVID-19 Vaccines* / adverse effects
COVID-19* / prevention & control
Humans
Immunogenicity, Vaccine
Immunoglobulin G
Muscular Diseases
Prospective Studies
SARS-CoV-2

Substances

Antibodies, Neutralizing
Antibodies, Viral
COVID-19 Vaccines
Immunoglobulin G

Associated data

ClinicalTrials.gov/NCT04754698