Immunogenicity following an additional dose of Coronavirus disease 2019 (COVID-19) vaccine was investigated in an extended primary series among kidney transplant (KT) recipients. Eighty-five KT participants were randomized to receive either an mRNA (M group; n = 43) or viral vector (V group; n = 42) vaccine. Among them, 62% were male, with a median (IQR) age of 50 (43–59) years and post-transplantation duration of 46 (26–82) months. At 2 weeks post-additional dose, there was no difference in the seroconversion rate between the M and V groups (70% vs. 65%, p = .63). A median (IQR) of anti-RBD antibody level was not statistically different between the M group compared with the V group (51.8 [5.1–591] vs. 28.5 [2.9–119.3] BAU/ml, p = .18). Furthermore, the percentage of participants with positive SARS-CoV-2 surrogate virus neutralization test results was not statistically different between groups (20% vs. 15%, p = .40). S1-specific T cell and RBD-specific B cell responses were also comparable between the M and V groups (230 [41–420] vs. 268 [118–510], p = .65 and 2 [0–10] vs. 2 [0–13] spot-forming units/10⁶ peripheral blood mononuclear cells, p = .60). In conclusion, compared with an additional dose of viral vector COVID-19 vaccine, a dose of mRNA COVID-19 vaccine did not elicit significantly different responses in KT recipients, regarding either humoral or cell-mediated immunity. (TCTR20211102003).

中文翻译：

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在肾移植受者中额外剂量的病毒载体 COVID-19 疫苗和 mRNA COVID-19 疫苗：一项随机对照试验（CVIM 4 研究）

在肾移植 (KT) 受者中进行了扩展的初级系列研究，研究了额外剂量的 2019 年冠状病毒病 (COVID-19) 疫苗后的免疫原性。85 名 KT 参与者被随机分配接受 mRNA（M 组；n  = 43）或病毒载体（V 组；n  = 42）疫苗。其中，62% 为男性，中位 (IQR) 年龄为 50 (43-59) 岁，移植后持续时间为 46 (26-82) 个月。在额外剂量后 2 周，M 组和 V 组之间的血清转化率没有差异（70% 对 65%，p  = .63）。M 组与 V 组相比，抗 RBD 抗体水平的中位数 (IQR) 无统计学差异（51.8 [5.1–591] 对比 28.5 [2.9–119.3] BAU/ml，p = .18). 此外，具有阳性 SARS-CoV-2 替代病毒中和测试结果的参与者的百分比在组间没有统计学差异（20% 对 15%，p  = .40）。M 组和 V 组之间的 S1 特异性 T 细胞和 RBD 特异性 B 细胞反应也相当（230 [41–420] 与 268 [118–510]，p = .65 和2  [0–10] 与2 [0–13] 个斑点形成单位/10 ^{6 个}外周血单核细胞，p  = .60)。总之，与额外剂量的病毒载体 COVID-19 疫苗相比，一剂 mRNA COVID-19 疫苗在 KT 接受者中没有引起显着不同的体液免疫或细胞免疫反应。(TCTR20211102003)。