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

• Published in: Lupus Vol. 31; no. 8; pp. 974 - 984
• Main Authors: Signorelli, Flavio, Balbi, Gustavo Guimarães Moreira, Aikawa, Nadia E, Silva, Clovis A, Kupa, Léonard de Vinci Kanda, Medeiros-Ribeiro, Ana C, Yuki, Emily FN, Pasoto, Sandra G, Saad, Carla GS, Borba, Eduardo F, Seguro, Luciana Parente Costa, Pedrosa, Tatiana, Oliveira, Vitor Antonio de Angeli, Costa, Ana Luisa Cerqueira de Sant’Ana, Ribeiro, Carolina T, Santos, Roseli Eliana Beseggio, Andrade, Danieli Castro Oliveira, Bonfá, Eloisa
• Format: Journal Article
• Language: English
• Published: London, England SAGE Publications 01-07-2022; Sage Publications Ltd
• Subjects: Antibodies; Antibodies, Antiphospholipid; Antiphospholipid antibodies; Antiphospholipid Syndrome; Autoantibodies; Autoimmune diseases; Cardiolipin; Clotting; Coronaviruses; COVID-19; COVID-19 - prevention & control; COVID-19 vaccines; COVID-19 Vaccines - adverse effects; Glycoprotein I; Humans; Immunogenicity; Immunogenicity, Vaccine; Immunoglobulin G; Immunoglobulin M; Lupus Erythematosus, Systemic - complications; Prospective Studies; Safety; SARS-CoV-2; Seroconversion; Severe acute respiratory syndrome coronavirus 2; Thrombosis; Vaccines; COVID-19; antiphospholipid syndrome; SARS-CoV-2 vaccine; vaccine immunogenicity; antiphospholipid antibodies
• ISSN: 0961-2033; 1477-0962
• DOI: 10.1177/09612033221102073

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.