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.
Keywords: COVID-19; SARS-CoV-2 vaccine; antiphospholipid antibodies; antiphospholipid syndrome; vaccine immunogenicity.
【저자키워드】 COVID-19, SARS-CoV-2 vaccine, antiphospholipid antibodies, vaccine immunogenicity., Antiphospholipid syndrome, 【초록키워드】 neutralizing antibody, SARS-CoV-2, IgG, IgM, Vaccine, vaccination, thrombosis, Safety, antibody, Sex, virus, anti-SARS-CoV-2, immunization, Coagulopathy, Seroconversion, Patient, complications, age, glycoprotein, coronavirus disease 19, patients, safety profile, inactivated, Evidence, Frequency, vaccine immunogenicity, Side effect, Participants, control group, increased risk, second dose, S1/S2, syndrome, naïve, blood collection, recent, event, remained, raised, provided, changes in, comparable, adenovirus-based, both group, 【제목키워드】 immunogenicity, antibody, Patient, syndrome,