Institute of Clinical Immunology and Allergy, University Hospital Hradec Kralove, Hradec Králové, Czechia.
Faculty of Medicine, Charles University, Hradec Králové, Czechia.
Int Arch Allergy Immunol. 2022;183(12):1297-1310. doi: 10.1159/000526375. Epub 2022 Oct 6.
Reports on the immunogenicity and efficacy of the Spikevax® vaccine against SARS-CoV-2 in immunodeficient patients are still scarce. We aimed to evaluate the safety and immunogenicity of the vaccine in patients with primary humoral immunodeficiency.
We enrolled 46 patients, including 34 patients with common variable immunodeficiency (CVID), 10 patients with unclassified hypogammaglobulinemia (HypoIg), and 2 patients with X-linked agammaglobulinemia. We collected the blood samples before vaccination (D 0), and 10 days (D +38) and 90 days (D +118) after the second vaccination. Further, we quantified SARS-CoV-2-specific T-cell response (QuantiFERON ELISA test), serum anti-RBD IgG, and anti-RBD IgA-specific antibodies (enzyme immunoassay).
We found that the vaccination elicited predominantly mild adverse events, comparable to healthy population. Vaccination response negatively correlated with a value of Immune Deficiency and Dysregulation Activity in all measured parameters. D +38, seroconversion for anti-RBD IgG and anti-RBD IgA was observed in 65% and 21% CVID patients, respectively. SARS-CoV-2-specific T-cell response was detected in less than 50% of CVID patients. Meanwhile, HypoIg patients had 100%, 90%, and 60% positivity rates for anti-RBD IgG, anti-RBD IgA, and T-cell response, respectively. Three months after the second vaccination, 82% of the responders remained positive for anti-RBD IgG, but only less than 50% remained positive for T-cell activity in CVIDs. Low immunogenicity was observed in patients with lung involvement and/or rituximab treatment history. No SARS-CoV-2 infection was reported within 6 months after the second vaccination.
Spikevax® seems to be safe with satisfactory immunogenicity in patients with primary humoral immunodeficiency.
关于 Spikevax®疫苗对 SARS-CoV-2 在免疫缺陷患者中的免疫原性和疗效的报告仍然很少。我们旨在评估该疫苗在原发性体液免疫缺陷患者中的安全性和免疫原性。
我们纳入了 46 名患者，包括 34 名普通变异性免疫缺陷（CVID）患者、10 名未分类低丙种球蛋白血症（HypoIg）患者和 2 名 X 连锁无丙种球蛋白血症患者。我们在接种前（D0）、接种后 10 天（D+38）和 90 天（D+118）采集血样。此外，我们定量检测了 SARS-CoV-2 特异性 T 细胞反应（QuantiFERON ELISA 试验）、血清抗 RBD IgG 和抗 RBD IgA 特异性抗体（酶联免疫吸附试验）。
我们发现，接种疫苗后主要出现轻度不良反应，与健康人群相当。接种反应与所有测量参数中的免疫缺陷和失调活动值呈负相关。在 CVID 患者中，D+38 时观察到抗 RBD IgG 和抗 RBD IgA 的血清学转换分别为 65%和 21%。SARS-CoV-2 特异性 T 细胞反应在不到 50%的 CVID 患者中检测到。同时，HypoIg 患者的抗 RBD IgG、抗 RBD IgA 和 T 细胞反应的阳性率分别为 100%、90%和 60%。第二次接种后 3 个月，82%的应答者仍保持抗 RBD IgG 阳性，但 CVID 患者的 T 细胞活性阳性者不足 50%。在有肺部受累和/或利妥昔单抗治疗史的患者中观察到低免疫原性。第二次接种后 6 个月内未报告 SARS-CoV-2 感染。
Spikevax®在原发性体液免疫缺陷患者中似乎是安全的，具有令人满意的免疫原性。
