BNT162b2 与 mRNA-1273 序贯加强 COVID-19 疫苗在慢性肾脏病及维持性透析患者中的应用。
BNT162b2 versus mRNA-1273 Third Dose COVID-19 Vaccine in Patients with CKD and Maintenance Dialysis Patients.
机构信息
Division of Nephrology, Department of Medicine, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.
Division of Nephrology, Department of Medicine, University Health Network, Toronto, Ontario, Canada.
出版信息
Clin J Am Soc Nephrol. 2024 Jan 1;19(1):85-97. doi: 10.2215/CJN.0000000000000328. Epub 2023 Oct 17.
BACKGROUND
There is a lack of randomized controlled trial data regarding differences in immunogenicity of varying coronavirus disease 2019 (COVID-19) mRNA vaccine regimens in CKD populations.
METHODS
We conducted a randomized controlled trial at three kidney centers in Toronto, Ontario, Canada, evaluating the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibody response after third dose vaccination. Participants ( n =273) with CKD not on dialysis or receiving dialysis were randomized 1:1 to third dose 30- µ g BNT162b2 (Pfizer-BioNTech) or 100- µ g mRNA-1273 (Moderna). The primary outcome of this study was SARS-CoV-2 IgG-binding antibodies to the receptor-binding domain (anti-RBD). Spike protein (antispike), nucleocapsid protein, and vaccine reactogenicity were also evaluated. Serology was measured before third dose and 1, 3, and 6 months after third dose. A subset of participants ( n =100) were randomly selected to assess viral pseudovirus neutralization against wild-type D614G, B.1.617.2 (Delta), and B.1.1.529 (Omicron BA.1).
RESULTS
Among 273 participants randomized, 94% were receiving maintenance dialysis and 59% received BNT162b2 for initial two dose COVID-19 vaccination. Third dose of mRNA-1273 was associated with higher mean anti-RBD levels (1871 binding antibody units [BAU]/ml; 95% confidence interval [CI], 829 to 2988) over a 6-month period in comparison with third dose BNT162b2 (1332 BAU/ml; 95% CI, 367 to 2402) with a difference of 539 BAU/ml (95% CI, 139 to 910; P = 0.009). Neither antispike levels nor neutralizing antibodies to wild-type, Delta, and Omicron BA.1 pseudoviruses were statistically different. COVID-19 infection occurred in 10% of participants: 15 (11%) receiving mRNA-1273 and 11 (8%) receiving BNT162b2. Third dose BNT162b2 was not associated with a significant different risk for COVID-19 in comparison with mRNA-1273 (hazard ratio, 0.78; 95% CI, 0.27 to 2.2; P = 0.63).
CONCLUSIONS
In patients with CKD, third dose COVID-19 mRNA vaccination with mRNA-1273 elicited higher SARS-CoV-2 anti-RBD levels in comparison with BNT162b2 over a 6-month period.
CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER
COVID-19 Vaccine Boosters in Patients With CKD (BOOST KIDNEY), NCT05022329 .
背景
在慢性肾脏病（CKD）人群中，不同的 2019 年冠状病毒病（COVID-19）mRNA 疫苗方案的免疫原性差异缺乏随机对照试验数据。
方法
我们在加拿大安大略省多伦多的三个肾脏中心进行了一项随机对照试验，评估了第三剂疫苗接种后严重急性呼吸综合征冠状病毒 2（SARS-CoV-2）抗体的反应。未接受透析或接受透析的 CKD 患者（n=273）按 1:1 随机分为第三剂 30-µg BNT162b2（辉瑞-生物科技）或 100-µg mRNA-1273（Moderna）。该研究的主要结局是受体结合域（anti-RBD）的 SARS-CoV-2 IgG 结合抗体。刺突蛋白（antispike）、核衣壳蛋白和疫苗反应原性也进行了评估。在第三剂疫苗接种前和第三剂疫苗接种后 1、3 和 6 个月进行血清学检测。随机选择了一部分参与者（n=100）来评估针对野生型 D614G、B.1.617.2（Delta）和 B.1.1.529（Omicron BA.1）的病毒假病毒中和作用。
结果
在 273 名随机分组的参与者中，94%正在接受维持性透析，59%接受 BNT162b2 进行初始两剂 COVID-19 疫苗接种。与第三剂 BNT162b2 相比，第三剂 mRNA-1273 在 6 个月内的平均 anti-RBD 水平（1871 结合抗体单位[BAU]/ml；95%置信区间[CI]，829 至 2988）更高，差异为 539 BAU/ml（95%CI，139 至 910；P=0.009）。刺突蛋白水平和针对野生型、Delta 和 Omicron BA.1 假病毒的中和抗体均无统计学差异。10%的参与者发生了 COVID-19 感染：15 名（11%）接受 mRNA-1273 治疗，11 名（8%）接受 BNT162b2 治疗。与 mRNA-1273 相比，第三剂 BNT162b2 接种与 COVID-19 无显著相关性（风险比，0.78；95%CI，0.27 至 2.2；P=0.63）。
结论
在 CKD 患者中，与 BNT162b2 相比，在 6 个月内，第三剂 COVID-19 mRNA 疫苗接种用 mRNA-1273 可引起更高的 SARS-CoV-2 anti-RBD 水平。
临床试验注册名称和注册号
慢性肾脏病患者的 COVID-19 疫苗加强剂（BOOST KIDNEY），NCT05022329。
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