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.
Lupus. 2022 Jul;31(8):974-984. doi: 10.1177/09612033221102073. Epub 2022 May 20.
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.
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.
We included 44 PAPS patients (31 naïve) and 132 CG (108 naïve) with comparable age (=0.982) and sex (>0.999). At D69, both groups had high and comparable SC (83.9% vs. 93.5%, =0.092), as well as NAb positivity (77.4% vs. 78.7%, =0.440), and NAb-activity (64.3% vs. 60.9%, =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 (=0.058) and IgM (=0.091); anti-beta-2 glycoprotein I (aβ2GPI) IgG (=0.513) and IgM (=0.468).
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.
新冠肺炎（COVID-19）有发生凝血功能障碍的风险，且常伴有抗磷脂抗体（aPL）。最近有报道称，腺病毒疫苗与血栓形成相关，这使得人们担心在原发性抗磷脂综合征（PAPS）患者中接种 SARS-CoV-2 疫苗可能会引发血栓并发症。我们的目的是评估在接种科兴新冠疫苗后，PAPS 患者的免疫原性、安全性和 aPL 产生情况，科兴新冠疫苗是一种针对 COVID-19 的灭活病毒疫苗。
这项前瞻性对照 4 期研究纳入了 PAPS 患者和对照组（CG），两组均接种两剂科兴新冠疫苗（D0/D28），并在接种前（D0）、D28 以及第二次接种后 6 周（D69）采血，以评估免疫原性/aPL 水平。主要结局为初次接种者在 D28/D69 时抗 SARS-CoV-2 S1/S2 IgG 和/或中和抗体（NAb）的血清转化率（SC）。还评估了安全性和 aPL 产生情况。
共纳入 44 例 PAPS 患者（31 例初次接种）和 132 例 CG（108 例初次接种），两组的年龄（=0.982）和性别（>0.999）具有可比性。在 D69 时，两组的 SC 均较高且相似（83.9% vs. 93.5%，=0.092），NAb 阳性率（77.4% vs. 78.7%，=0.440）和 NAb 活性（64.3% vs. 60.9%，=0.689）也相似。在 6 个月内或其他中度/重度副作用均未观察到血栓形成事件。在整个研究过程中，PAPS 患者的 aPL 水平在 D0 时与 D28 时和 D69 时相比均保持稳定：抗心磷脂（aCL）IgG（=0.058）和 IgM（=0.091）；抗β2 糖蛋白 I（aβ2GPI）IgG（=0.513）和 IgM（=0.468）。
本研究为科兴新冠疫苗在 PAPS 中的高免疫原性和安全性提供了新证据。此外，科兴新冠疫苗并未引发血栓形成，也未引起 aPL 产生的变化。
