Immunogenicity, safety, and antiphospholipid antibodies after SARS-CoV-2 vaccine in patients with primary antiphospholipid syndrome
Immunogenicity, safety, and antiphospholipid antibodies after SARS-CoV-2 vaccine in patients with primary antiphospholipid syndrome
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DOI：
10.1177/09612033221102073
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发表时间：
2022-05-20
期刊：
影响因子：
2.6
通讯作者：
Bonfa, Eloisa
中科院分区：
文献类型：
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作者：
Signorelli, Flavio;Balbi, Gustavo Guimaraes Moreira;Bonfa, Eloisa
目的 冠状病毒病 19 (COVID-19) 因抗磷脂抗体 (aPL) 出现频率较高而导致凝血病的风险增加。最近有关腺病毒疫苗相关血栓形成的报道引起了人们的担忧，即原发性抗磷脂综合征 (PAPS) 患者的 SARS-CoV-2 免疫可能会引发凝血并发症。我们的目标是评估 PAPS 患者接种科兴-CoronaVac（一种针对 COVID-19 的灭活病毒疫苗）后的免疫原性、安全性和 aPL 产生。方法 这项针对 PAPS 患者和对照组 (CG) 的前瞻性对照 4 期研究包括两剂科兴-CoronaVac (D0/D28) 以及疫苗接种前 (D0)、D28 和第二剂后 6 周 (D69) 的血液采集，以检测免疫原性/aPL 水平。结果是初始参与者在 D28/D69 时抗 SARS-CoV-2 S1/S2 IgG 和/或中和抗体 (NAb) 的血清转化 (SC) 率。还评估了安全性和 aPL 生产。结果 我们纳入了年龄 (p=0.982) 和性别 (p>0.999) 相当的 44 名 PAPS 患者（31 名初治患者）和 132 名 CG 患者（108 名初治患者）。在第 69 天，两组均具有较高且可比的 SC（83.9% vs. 93.5%，p=0.092），以及 NAb 阳性（77.4% vs. 78.7%，p=0.440）和 NAb 活性（64.3% vs. 60.9%，p=0.689）。未观察到长达 6 个月的血栓事件或其他中度/重度副作用。在整个研究期间，PAPS 患者在 D0、D28 和 D69 时保持稳定的 aPL 水平：抗心磷脂 (aCL) IgG (p=0.058) 和 IgM (p=0.091)；抗 beta-2 糖蛋白 I (a beta 2GPI) IgG (p=0.513) 和 IgM (p=0.468)。结论 我们提供了新的证据表明科兴-CoronaVac 在 PAPS 中具有高免疫原性和安全性。此外，Sinovac-CoronaVac 不会引发血栓形成，也不会引起 aPL 产生的变化。
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 naive participants. Safety and aPL production were also assessed. Results We included 44 PAPS patients (31 naive) and 132 CG (108 naive) 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 (a beta 2GPI) 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.