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.
【저자키워드】 COVID-19, immunogenicity, Neutralizing antibodies, Safety., anti-SARS-CoV-2 vaccine, myositis, 【초록키워드】 neutralizing antibody, IgG, HIV/AIDS, Vaccine, immune response, therapy, protocol, serology, CoronaVac, Immunosuppression, Comorbidity, Sex, drug, RT-PCR, anti-SARS-CoV-2, SARS-CoV-2 vaccine, vaccine dose, Neutralizing activity, Seroconversion, Myopathy, adverse event, Patient, Mild, age, Neutralizing, Autoimmune, disease, moderate, parameters, inactivated, Frequency, dose, Safe, interquartile range, control group, 95%CI, second dose, S1/S2, disease status, participant, positive, significantly lower, CTRL, immunogenicity analysis, pre-vaccination, geometric mean titre, evaluate, reduced, median, less, comparable, Type, SAM, All participant, baseline, GMT, in both group, IQR, were excluded, 【제목키워드】 SARS-CoV-2, Vaccine, virus, Controlled trial, Autoimmune, inactivated, systemic,