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

Abstract

Introduction There is no study specifically focused on SARS-CoV-2 vaccine in primary Sjögren’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 Sjögren’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. Trial registration ClinicalTrials.gov Identifier: NCT04754698. Key Points • Sinovac-CoronaVac vaccine is safe in pSS, without a detrimental effect on systemic disease activity, and has a moderate short-term humoral response • A booster dose should be considered in these patients

Comprehensive evaluation of the effect of inactivated SARS‐CoV‐2 vaccination on female fertility: A retrospective cohort study

“…This difference may be related to the relative immunogenic strength of vaccines produced by different methods. Table 6 compares the incidence of adverse reactions after mRNA or inactivated SARS‐CoV‐2 vaccination 21–36 . Overall, subjects who received the mRNA vaccine reported more adverse events (Table 6).…”

“…Table 6 compares the incidence of adverse reactions after mRNA or inactivated SARS-CoV-2 vaccination. [21][22][23][24][25][26][27][28][29][30][31][32][33][34][35][36] Overall, subjects who received the mRNA vaccine reported more adverse events (Table 6). Moreover, in previous studies on COVID-19 patients, it has been proved that the sex hormone levels are associated with concentrations of many inflammatory cytokines such as interleukin 6, C-reactive protein and interferon γ-inducible protein 10.…”

Higher antibody responses after mRNA-based vaccine compared to inactivated vaccine against SARS-CoV-2 in Behcet’s syndrome

“…While we observed significantly diminished antibody titers in BS patients, especially in those treated with anti-TNF agents compared to healthy individuals among Cor-onaVac recipients, no such difference was detected in the BioNTech group. We and others have previously shown that immunocompromised patients often fail to show an adequate response to SARS-CoV-2 vaccines, as indicated by lower protective immune response rates compared with healthy individuals [5][6][7][8][24][25][26][27][28][29][30][31][32][33][34][35][36]. Almost all DMARDs including mycophenolate mofetil, methotrexate, rituximab, abatacept and glucocorticoids have been shown to blunt humoral responses [7,[24][25][26][31][32][33].…”

Safety and efficacy of SARS-CoV-2 vaccination in 1237 patients with primary Sjögren syndrome

“…In all these studies, inflammatory arthritis represented more than 50% of people included, with SS representing only 5-15% of cases. Two case-control studies focused on SS evaluating around 50 patients each have been recently published reporting no specific safety signals (19,20). This is one of the largest reported series of vaccinated patients affected by a specific systemic autoimmune disease, with very few studies evaluating until now more than 1000 patients to date (28).…”

“…However, except for patients with high disease activity, studies with a small number of patients with systemic autoimmune diseases show no increased risk of con-tracting SARS-CoV-2 or a worse prognosis of COVID-19 than individuals without RMDs, possibly explaining the increased risk seen for glucocorticoid use (9,10). Recent large studies (Supplementary Table S1) have evaluated the safety and efficacy of COVID-19 vaccines in patients with immune-mediated diseases (11)(12)(13)(14)(15)(16)(17)(18), but specific information in patients with SS is limited to single-centre, small-size cohorts of patients (19,20). The objective of this study was to analyse the safety and efficacy of SARS-Cov-2 vaccination in a large international cohort of patients with SS.…”