Immunogenicity, safety, and antiphospholipid antibodies after SARS-CoV-2 vaccine in patients with primary antiphospholipid syndrome

Abstract

Objective Coronavirus disease 19 (COVID-19) has an increased risk of coagulopathy with high frequency of antiphospholipid antibodies (aPL). Recent reports of thrombosis associated with adenovirus-based vaccines raised concern that SARS-CoV-2 immunization in primary antiphospholipid syndrome (PAPS) patients may trigger clotting complications. Our objectives were to assess immunogenicity, safety, and aPL production in PAPS patients, after vaccinating with Sinovac-CoronaVac, an inactivated virus vaccine against COVID-19. Methods This prospective controlled phase-4 study of PAPS patients and a control group (CG) consisted of a two-dose Sinovac-CoronaVac (D0/D28) and blood collection before vaccination (D0), at D28 and 6 weeks after second dose (D69) for immunogenicity/aPL levels. Outcomes were seroconversion (SC) rates of anti-SARS-CoV-2 S1/S2 IgG and/or neutralizing antibodies (NAb) at D28/D69 in naïve participants. Safety and aPL production were also assessed. Results We included 44 PAPS patients (31 naïve) and 132 CG (108 naïve) with comparable age ( p=0.982) and sex ( p>0.999). At D69, both groups had high and comparable SC (83.9% vs. 93.5%, p=0.092), as well as NAb positivity (77.4% vs. 78.7%, p=0.440), and NAb-activity (64.3% vs. 60.9%, p=0.689). Thrombotic events up to 6 months or other moderate/severe side effects were not observed. PAPS patients remained with stable aPL levels throughout the study at D0 vs. D28 vs. D69: anticardiolipin (aCL) IgG ( p=0.058) and IgM ( p=0.091); anti-beta-2 glycoprotein I (aβ2GPI) IgG ( p=0.513) and IgM ( p=0.468). Conclusion We provided novel evidence that Sinovac-CoronaVac has high immunogenicity and safety profile in PAPS. Furthermore, Sinovac-CoronaVac did not trigger thrombosis nor induced changes in aPL production.

COVID-19 vaccine affects neither prothrombotic antibody profile nor thrombosis in primary anti-phospholipid syndrome: a prospective study

“…Two surveys in patients with aPL antibodies reported that COVID-19 vaccination did not result in severe adverse events [ 18 , 19 ]. A study reported that COVID-19 vaccine did not affect aCL and anti-β2GP1 IgG and IgM titres in primary APS patients [ 20 ]. A step further, our study is the first prospective study designed to evaluate the comprehensive autoimmune antibody profile (including anti-PF4-heparin antibodies) as well as clinical pictures in pre- and post-vaccinated primary APS patients.…”

COVID-19 Vaccines and Autoimmune Hematologic Disorders

“…The used assays were Sure-Vue rapid plasma reagin (RPR) test, (Thermo Fisher Scientific, Waltham, MA, USA) and Macro-Vue RPR test (Becton Dickinson) [118]. These data have been validated by other groups, including no modification in previous positive intensity before and after vaccination in patients suffering from APS [119,120]. Despite this, larger longitudinal studies are needed to determine the incidence and window of false reactivity.…”

Longitudinal efficacy and toxicity of SARS-CoV-2 vaccination in cancer patients treated with immunotherapy

“…Borghi et al have reported that vaccination may trigger low titre autoantibody production, including anti-phospholipid antibodies, in health care workers [44]. In contrast, a recent study looking into the dynamics of auto-antibodies after SARS-CoV-2 vaccination in patients with antiphospholipid syndrome, did not observe a statistically significant increase of beta-2 glycoprotein 1 [45]. Moreover, we found an increase in antibodies against nucleosome, which is the cardinal antigen implicated in the pathogenesis of systemic lupus erythematosus [46] and an increase in antibodies against SPLUNC2 which belongs to an extended group of proteins expressed in the upper airways, nose and mouth, for which little is known [47].…”