POS0776 IMMUNOGENICITY AND SAFETY OF INACTIVATED AND mRNA COVID-19 VACCINES IN PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS

Abstract

BackgroundVaccination against SAR-CoV-2 is a new campaign and believed to be the key to end the pandemic. Currently, there are two COVID-19 vaccines with different mechanism of action available in Hong Kong - they are the inactivated virus vaccine and the mRNA-based vaccine. Both vaccines have obtained approval for emergency use by the World Health Organization (WHO) and were widely deployed globally (1). A mass voluntary vaccination program for all Hong Kong residents has started in late February, 2021 (2). However, the efficacy and safety of COVID-19 vaccines in patients with SLE is uncertain due to a complex interplay of underlying autoimmunity and immunosuppressive therapies used.ObjectivesThis study was to investigate the effects of both inactivated and mRNA COVID-19 vaccines in patients with SLE.MethodsThis was a prospective, single-centre, case-control study. Patients with SLE planning to receive COVID-19 vaccines were recruited and matched 1:1 with healthy controls. The immunogenicity of the COVID-19 vaccines was assessed by a surrogate neutralization assay at 28 days after the second dose. The main outcomes included the antibody response and adverse effects comparing SLE patients and controls. Predictors of responses in SLE patients were analyzed. The change of SLE disease activity was evaluated.ResultsSixty-five SLE patients received 2 doses of COVID-19 vaccines (Comirnaty: 38; CoronaVac: 27) were recruited. Many of them were on systemic glucocorticoids (75.8%) and immunosuppressants (54.5%). At day 28 after the second dose of vaccines, 92.3% (Comirnaty: 100%; CoronaVac: 81.5%, p=0.01) had positive neutralizing antibody. However, compared to the age, gender, vaccine type matched controls, the level of neutralizing antibody was significantly lower (p<0.001) in patients with SLE (Figure 1). The self-reported side effects of the vaccines in lupus patients were common but mild, and were more frequent in the Comirnaty group. There was no significant change in lupus disease activity up to 28 days after vaccination. The independent predictors of neutralizing antibody level included the dosage of systemic glucocorticoids, use of mycophenolate and type of vaccines (Table 1).Table 1.Multivariate linear regression analysis for neutralizing antibody activityBeta95% confidence intervalP valueAge-0.022-0.425 – 0.3810.914Gender8.1625 (92.6)0.296SLEDAI-2k-1.96-4.22 – 0.310.088Prednisolone dosage-2.01-3.66 - -0.370.018Mycophenolate mofetil-15.2-24.4 - -6.00.002Type of vaccines: Comirnaty28.820.1 – 37.5<0.001Figure 1.Distribution of neutralizing antibody levels after COVID-19 vaccines comparing (A) SLE patients and matched controls, (B) SLE patients and matched controls in two vaccine subgroups, and (C) two vaccine types in SLE patients. Data for each group are presented as box plots: central values within boxes correspond to median; the range between the lower (Q1) and upper (Q3) bounds of the boxes is the IQR. Whiskers represent scores outside IQR and ends in maximum (higher “calculated value” = Q3 + 1.5 x IQR) and minimum (lower “calculated value” = Q1 – 1.5 x IQR). Spots are outliers above the maximum or under the minimum values. Data regarding were analyzed using Mann-Whitney-U test. Dotted line denotes the cut-off level for positivity (30%).ConclusionCOVID-19 vaccines produced satisfactory but impaired serological response in SLE patients compared to controls which was dependent on the immunosuppressive medications use and type of vaccines received. There was no new short-term safety signal noted. Booster dose is recommended.