Immunogenicity following inactivated SARS-CoV-2 vaccination among solid organ transplant recipients has not been assessed. Seventy-five patients (37 kidney transplant [KT] recipients and 38 healthy controls) received two doses, at 4-week intervals, of an inactivated whole-virus SARS-CoV-2 vaccine. SARS-CoV-2-specific humoral (HMI) and cell-mediated immunity (CMI) were measured before, 4 weeks post-first dose, and 2 weeks post-second dose. The median (IQR) age of KT recipients was 50 (42–54) years and 89% were receiving calcineurin inhibitors/mycophenolate/corticosteroid regimens. The median (IQR) time since transplant was 4.5 (2–9.5) years. Among 35 KT patients, the median (IQR) of anti-RBD IgG level measured by CLIA after vaccination was not different from baseline, but was significantly lower than in controls (2.4 [1.1–3.7] vs. 1742.0 [747.7–3783.0] AU/ml, p < .01) as well as percentages of neutralizing antibody inhibition measured by surrogate viral neutralization test (0 [0–0] vs. 71.2 [56.8–92.2]%, p < .01). However, the median (IQR) of SARS-CoV-2 mixed peptides-specific T cell responses measured by ELISpot was significantly increased compared with baseline (30 [4–120] vs. 12 [0–56] T cells/10⁶ PBMCs, p = .02) and not different from the controls. Our findings revealed weak HMI but comparable CMI responses in fully vaccinated KT recipients receiving inactivated SARS-CoV-2 vaccination compared to immunocompetent individuals (Thai Clinical Trials Registry, TCTR20210226002).

中文翻译：

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肾移植受者用灭活 COVID-19 疫苗免疫后 SARS-CoV-2 特异性体液和细胞介导的免疫反应（CVIM 1 研究）

尚未评估实体器官移植受者接种灭活 SARS-CoV-2 疫苗后的免疫原性。75 名患者（37 名肾移植 [KT] 接受者和 38 名健康对照者）每 4 周接种两剂灭活的全病毒 SARS-CoV-2 疫苗。在第一次给药前、第一次给药后 4 周和第二次给药后 2 周测量了 SARS-CoV-2 特异性体液 (HMI) 和细胞介导免疫 (CMI)。KT 接受者的中位 (IQR) 年龄为 50 (42–54) 岁，89% 正在接受钙调神经磷酸酶抑制剂/霉酚酸酯/皮质类固醇方案。移植后的中位 (IQR) 时间为 4.5 (2–9.5) 年。在 35 名 KT 患者中，接种疫苗后通过 CLIA 测量的抗 RBD IgG 水平的中位数 (IQR) 与基线没有差异，但显着低于对照组（2.4 [1.1–3.7] 对 1742.0 [747.p  < .01) 以及通过替代病毒中和试验测量的中和抗体抑制百分比（0 [0–0] 对比 71.2 [56.8–92.2]%，p  < .01）。然而，与基线相比，通过 ELISpot 测量的 SARS-CoV-2 混合肽特异性 T 细胞反应的中位数 (IQR) 显着增加（30 [4–120] 对比 12 [0–56] T 细胞/10· ⁶  PBMC , p  = .02) 并且与对照组没有区别。我们的研究结果表明，与具有免疫能力的个体相比，接受灭活 SARS-CoV-2 疫苗接种的完全接种疫苗的 KT 接受者的 HMI 较弱，但 CMI 反应相当（泰国临床试验注册中心，TCTR20210226002）。