Serological SARS-CoV-2 antibody response, potential predictive markers and safety of BNT162b2 mRNA COVID-19 vaccine in haematological and oncological patients
Serological SARS-CoV-2 antibody response, potential predictive markers and safety of BNT162b2 mRNA COVID-19 vaccine in haematological and oncological patients
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DOI：
10.1111/bjh.17743
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发表时间：
2021-08-03
影响因子：
6.5
通讯作者：
Winder, Thomas
中科院分区：
文献类型：
--
作者：
Benda, Magdalena;Mutschlechner, Beatrix;Winder, Thomas
血液肿瘤患者面临严重急性呼吸综合征冠状病毒-2 (SARS-CoV-2) 感染的风险。目前，疫苗接种是评价最好的预防策略。在本研究中，我们旨在评估 BNT162b2 在血液肿瘤患者中的血清学反应、预测标记物和安全性。总共 259 名血液肿瘤患者接种了两剂 30 μg 剂量的 BNT162b2，间隔 21 天。在疫苗接种前以及首次接种后 3 周和 7 周（T1、T2），通过 ELECSYS(R) 抗 SARS-CoV-2-S 免疫测定评估血清学反应。进行了安全评估。在 T2 时，在 71 个中心点（4%）的血液患者和 94 个中心点（5%）的肿瘤患者中检测到抗体（P < 0 中心点 001）。接受全身治疗的血液病患者的无反应风险增加 2 倍（95% 置信区间 3 中心点 2-63 中心点 3，P = 0 中心点 001）。淋巴瘤或慢性淋巴细胞白血病患者亚组出现血清学无反应的风险最高。低免疫球蛋白 G (IgG) 水平、淋巴细胞和自然杀伤 (NK) 细胞计数与不良血清学反应显着相关（P < 0 中心点 05）。疫苗接种耐受性良好，只有 7% 的 2 个中心点患者报告出现严重副作用。与没有副作用的患者相比，有副作用的患者产生了更高的 S/RBD 抗体滴度（P = 0 中心点 038）。接受治疗的血液学患者出现血清学无反应的风险最高。研究发现淋巴细胞、NK 细胞和 IgG 水平低与血清学无反应有关。肿瘤患者的血清学反应令人鼓舞。 BNT162b2 在血液肿瘤患者中使用是安全的。
Haemato-oncological patients are at risk in case of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection. Currently, vaccination is the best-evaluated preventive strategy. In the present study, we aimed to assess serological response, predictive markers, and safety of BNT162b2 in haemato-oncological patients. A total of 259 haemato-oncological patients were vaccinated with two 30 mu g doses of BNT162b2 administered 21 days apart. Serological response was assessed by ELECSYS(R) Anti-SARS-CoV-2-S immunoassay before vaccination, and at 3 and 7 weeks after the first dose (T1, T2). Safety assessment was performed. At T2 spike protein receptor binding domain (S/RBD) antibodies were detected in 71 center dot 4% of haematological and in 94 center dot 5% of oncological patients (P < 0 center dot 001). Haematological patients receiving systemic treatment had a 14 center dot 2-fold increased risk of non-responding (95% confidence interval 3 center dot 2-63 center dot 3, P = 0 center dot 001). Subgroups of patients with lymphoma or chronic lymphocytic leukaemia were at highest risk of serological non-response. Low immunoglobulin G (IgG) level, lymphocyte- and natural killer (NK)-cell counts were significantly associated with poor serological response (P < 0 center dot 05). Vaccination was well tolerated with only 2 center dot 7% of patients reporting severe side-effects. Patients with side-effects developed a higher S/RBD-antibody titre compared to patients without side-effects (P = 0 center dot 038). Haematological patients under treatment were at highest risk of serological non-response. Low lymphocytes, NK cells and IgG levels were found to be associated with serological non-response. Serological response in oncological patients was encouraging. The use of BNT162b2 is safe in haemato-oncological patients.