血液系统与肿瘤患者中 BNT162b2 mRNA COVID-19 疫苗的血清学 SARS-CoV-2 抗体应答、潜在预测标志物及安全性

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 g doses of BNT162b2 administered 21 days apart. Serological response was assessed by ELECSYS 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 4% of haematological and in 94 5% of oncological patients (P < 0 001). Haematological patients receiving systemic treatment had a 14 2-fold increased risk of non-responding (95% confidence interval 3 2-63 3, P = 0 001).

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 05). Vaccination was well tolerated with only 2 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 = 0 038). 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.