This study evaluated the safety and immunogenicity of BNT162b2 vaccine in patients with hematological malignancies. Antibodies blocking spike binding to immobilized ACE-2 (NAb) correlated with anti-Spike (S) IgG d42 titers (Spearman r = 0.865, p < 0.0001), and an anti-S IgG d42 level ≥3100 UA/mL was predictive of NAb ≥ 30%, the positivity cutoff for NAb (p < 0.0001). Only 47% of the patients achieved an anti-S IgG d42 level ≥3100 UA/mL after the two BNT162b2 inocula, compared to 87% of healthy controls. In multivariable analysis, male patients, use of B-cell targeting treatment within the last 12 months prior to vaccination, and CD19⁺ B-cell level <120/uL, were associated with a significantly decreased probability of achieving a protective anti-S IgG level after the second BNT162b2 inoculum. Finally, using the IFN-γ ELISPOT assay, we found a significant increase in T-cell response against the S protein, with 53% of patients having an anti-S IgG-positive ELISPOT after the second BNT162b2 inoculum. There was a correlation between the anti-S ELISPOT response and IgG d42 level (Spearman r = 0.3026, p = 0.012). These findings suggest that vaccination with two BNT162b2 inocula translates into a significant increase in humoral and cellular response in patients with hematological malignancies, but only around half of the patients can likely achieve effective immune protection against COVID-19.

本研究评估了 BNT162b2 疫苗在血液系统恶性肿瘤患者中的安全性和免疫原性。阻断与固定化 ACE-2 (NAb) 结合的抗体与抗 Spike (S) IgG d42 滴度相关（Spearman r = 0.865，p  < 0.0001），并且抗 S IgG d42 水平≥3100 UA/mL 可预测NAb ≥ 30%，NAb 的阳性截止值 ( p  < 0.0001)。在两次 BNT162b2 接种后，只有 47% 的患者的抗 S IgG d42 水平≥3100 UA/mL，而健康对照的这一比例为 87%。在多变量分析中，男性患者在接种疫苗前的最后 12 个月内使用 B 细胞靶向治疗，以及 CD19 ⁺B 细胞水平 <120/uL，与在第二次 BNT162b2 接种后达到保护性抗 S IgG 水平的可能性显着降低相关。最后，使用 IFN-γ ELISPOT 测定，我们发现 T 细胞对 S 蛋白的反应显着增加，在第二次 BNT162b2 接种后，53% 的患者具有抗 S IgG 阳性 ELISPOT。抗 S ELISPOT 反应与 IgG d42 水平之间存在相关性（Spearman r = 0.3026，p  = 0.012）。这些发现表明，接种两种 BNT162b2 接种物可显着增加血液系统恶性肿瘤患者的体液和细胞反应，但只有大约一半的患者可能对 COVID-19 实现有效的免疫保护。