Petr Vojtech, Zahradka Ivan, Modos Istvan, Roder Matej, Fialova Martina, Machkova Jana, Kabrtova Katerina, Hruba Petra, Magicova Maria, Slavcev Antonij, Striz Ilja, Viklicky Ondrej
Department of Nephrology, Institute for Clinical and Experimental Medicine, Prague, Czech Republic.
Information Technology Department, Institute for Clinical and Experimental Medicine, Prague, Czech Republic.
Transplant Direct. 2024 May 17;10(6):e1645. doi: 10.1097/TXD.0000000000001645. eCollection 2024 Jun.
Booster doses of SARS-CoV-2 mRNA vaccines are commonly used in kidney transplant recipients (KTRs). However, there is uncertainty regarding the waning of vaccination responses and immunological safety in KTRs.
A total of 123 KTRs were included in the final analysis of this prospective observational cohort study. The aim was to evaluate the immunogenicity and immunological safety. SARS-CoV-2 antispike IgG antibodies and anti-HLA antibodies were measured at baseline and then at months 3, 6, and 12 after vaccination with the first booster dose (ie, the third vaccine dose). Antibodies against S1 and S2 subunits of SARS-CoV-2 were evaluated using an immunochemiluminescent assay (cutoff 9.5 AU/mL, sensitivity 91.2%, and specificity 90.2%). Anti-HLA antibodies were analyzed using single-antigen bead technology.
Seroconversion was reached in 65% of KTRs previously nonresponding to 2-dose mRNA vaccination; the overall seroconversion rate 3 mo after the first booster dose was 83%. Vaccination induced a durable humoral response, and the antibody levels were stable during the 12-mo study follow-up. Higher age (exponentiated beta coefficient [e] 0.97; 95% confidence interval [CI], 0.943-0.997) and a full dose of mycophenolate (e 0.296; 95% CI, 0.089-0.984) were negatively associated with SARS-CoV-2 IgG antibody levels, whereas better graft function (e1.021; 95% CI, 1.005-1.037) was associated positively. There were no systematic signs of anti-HLA antibody development after vaccination. However, during the follow-up, there was a nonsignificant signal of an increase in anti-HLA antibodies in those who developed COVID-19.
Additional booster doses of SARS-CoV-2 mRNA vaccines induce durable antibody response even in a large subset of previous nonresponders and are not associated with the risk of allosensitization. Furthermore, a signal linking COVID-19 to the development of anti-HLA antibodies was observed, and this should be confirmed and further examined (NCT05483725).
严重急性呼吸综合征冠状病毒2（SARS-CoV-2）信使核糖核酸（mRNA）疫苗的加强剂量常用于肾移植受者（KTR）。然而，KTR中疫苗接种反应的减弱和免疫安全性存在不确定性。
本前瞻性观察队列研究的最终分析共纳入123名KTR。目的是评估免疫原性和免疫安全性。在基线时以及接种第一剂加强针（即第三剂疫苗）后的第3、6和12个月测量SARS-CoV-2抗刺突免疫球蛋白G（IgG）抗体和抗人类白细胞抗原（HLA）抗体。使用免疫化学发光法（临界值9.5 AU/mL，灵敏度91.2%，特异性90.2%）评估针对SARS-CoV-2 S1和S2亚基的抗体。使用单抗原珠技术分析抗HLA抗体。
65%先前对两剂mRNA疫苗无反应的KTR实现了血清转化；首次加强针接种后3个月的总体血清转化率为83%。疫苗接种诱导了持久的体液反应，并且在12个月的研究随访期间抗体水平稳定。较高年龄（指数化β系数[e]0.97；95%置信区间[CI]，0.943 - 0.997）和全剂量霉酚酸酯（e 0.296；95% CI，0.089 - 0.984）与SARS-CoV-2 IgG抗体水平呈负相关，而较好的移植功能（e1.021；95% CI，1.005 - 1.037）呈正相关。接种疫苗后没有抗HLA抗体产生的系统性迹象。然而，在随访期间，感染2019冠状病毒病（COVID-19）的患者中抗HLA抗体有非显著升高的信号。
额外剂量的SARS-CoV-2 mRNA疫苗加强针即使在很大一部分先前无反应者中也能诱导持久的抗体反应，并且与同种致敏风险无关。此外，观察到COVID-19与抗HLA抗体产生之间的关联信号，这一点应予以确认并进一步研究（临床试验注册号：NCT05483725）。
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