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

Autor: Signorelli F; Rheumatology Division, Hospital das Clínicas HCFMUSP, Faculdade de Medicina, 117265Universidade de São Paulo, Brazil.; Rheumatology Division, Hospital Universitário Pedro Ernesto, 28130Universidade do Estado do Rio de Janeiro, Brazil., Balbi GGM; Rheumatology Division, Hospital das Clínicas HCFMUSP, Faculdade de Medicina, 117265Universidade de São Paulo, Brazil.; Rheumatology Division, Hospital Universitário, 424848Universidade Federal de Juiz de Fora, Brazil., Aikawa NE; Pediatric Rheumatology Unit, Instituto da Criança, Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, Brazil., Silva CA; Pediatric Rheumatology Unit, Instituto da Criança, Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, Brazil., Kupa LVK; Rheumatology Division, Hospital das Clínicas HCFMUSP, Faculdade de Medicina, 117265Universidade de São Paulo, Brazil., Medeiros-Ribeiro AC; Rheumatology Division, Hospital das Clínicas HCFMUSP, Faculdade de Medicina, 117265Universidade de São Paulo, Brazil., Yuki EF; Rheumatology Division, Hospital das Clínicas HCFMUSP, Faculdade de Medicina, 117265Universidade de São Paulo, Brazil., Pasoto SG; Rheumatology Division, Hospital das Clínicas HCFMUSP, Faculdade de Medicina, 117265Universidade de São Paulo, Brazil., Saad CG; Rheumatology Division, Hospital das Clínicas HCFMUSP, Faculdade de Medicina, 117265Universidade de São Paulo, Brazil., Borba EF; Rheumatology Division, Hospital das Clínicas HCFMUSP, Faculdade de Medicina, 117265Universidade de São Paulo, Brazil., Seguro LPC; Rheumatology Division, Hospital das Clínicas HCFMUSP, Faculdade de Medicina, 117265Universidade de São Paulo, Brazil., Pedrosa T; Rheumatology Division, Hospital das Clínicas HCFMUSP, Faculdade de Medicina, 117265Universidade de São Paulo, Brazil., Oliveira VAA; Rheumatology Division, Hospital das Clínicas HCFMUSP, Faculdade de Medicina, 117265Universidade de São Paulo, Brazil., Costa ALCS; Rheumatology Division, Hospital das Clínicas HCFMUSP, Faculdade de Medicina, 117265Universidade de São Paulo, Brazil., Ribeiro CT; Rheumatology Division, Hospital das Clínicas HCFMUSP, Faculdade de Medicina, 117265Universidade de São Paulo, Brazil., Santos REB; Central Laboratory Division, Hospital das Clínicas HCFMUSP, Faculdade de Medicina, 117265Universidade de São Paulo, Brazil., Andrade DCO; Rheumatology Division, Hospital das Clínicas HCFMUSP, Faculdade de Medicina, 117265Universidade de São Paulo, Brazil., Bonfá E; Rheumatology Division, Hospital das Clínicas HCFMUSP, Faculdade de Medicina, 117265Universidade de São Paulo, Brazil.
Jazyk: angličtina
Zdroj: Lupus [Lupus] 2022 Jul; Vol. 31 (8), pp. 974-984. Date of Electronic Publication: 2022 May 20.
DOI: 10.1177/09612033221102073
Abstrakt: 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.
Databáze: MEDLINE
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