印度尼西亚日惹地区接受血液透析的终末期肾病患者中 COVID-19 BNT162b2 加强疫苗的免疫原性和安全性：一项队列前瞻性研究。
Immunogenicity and safety of COVID-19 BNT162b2 booster vaccine in end-stage kidney disease patients receiving haemodialysis in Yogyakarta, Indonesia: a cohort prospective study.
机构信息
Department of Internal Medicine, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada/Dr. Sardjito General Hospital, Yogyakarta, Indonesia.
Clinical Epidemiology and Biostatistics Unit, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada/Dr. Sardjito General Hospital, Yogyakarta, Indonesia.
出版信息
BMC Nephrol. 2023 May 30;24(1):151. doi: 10.1186/s12882-023-03218-x.
BACKGROUND
A significant decrease in antibody titres several months after COVID-19 primary vaccination in end-stage kidney disease (ESKD) patients receiving maintenance haemodialysis has recently been reported. The waning in antibody titres has led to the recommendations for a booster dose to increase the antibody titres after vaccination. Consequently, it is crucial to analyse the long-term humoral immune responses after COVID-19 primary vaccination and assess the immunogenicity and safety of booster doses in haemodialysis (HD) patients.
METHODS
Patients on maintenance haemodialysis who received the primary vaccine of CoronaVac (Sinovac) vaccine were administered with BNT162b2 (Pfizer-BioNTech) as the booster dose. The immunogenicity was assessed before (V1), one month (V2) and eight months (V3) after the primary vaccination, as well as one month after the booster dose (V4). Patients were followed up one month after the booster dose to assess the adverse events (AEs).
RESULTS
The geometric mean titre (GMT) of anti-SARS-CoV-2 S-RBD IgG antibody at 8 months after the primary vaccination increased significantly to 5,296.63 (95%CI: 2,930.89-9,571.94) U/mL (p = < 0.0001) compared to before the primary vaccination. The GMT also increased significantly to 19,142.56 (95% CI: 13,489.63-27,227.01) U/mL (p < 0.0001) 1 month after the booster vaccine. Meanwhile, the median inhibition rate of neutralizing antibodies (NAbs) at 8 months after the primary vaccine and 1 month after the booster dose were not significantly different (p > 0.9999). The most common AEs after the booster dose included mild pain at the injection site (55.26%), mild fatigue (10.53%), and swelling at the injection site (10.53%). No serious AEs were reported.
CONCLUSIONS
The majority of ESKD patients on haemodialysis mounted a good antibody response to the BNT162b2 booster vaccination with tolerable adverse events.
背景
最近有报道称，在接受维持性血液透析的终末期肾病（ESKD）患者中，COVID-19 初次疫苗接种后数月，抗体滴度显著下降。抗体滴度的下降导致了接种后增加加强剂量以提高抗体滴度的建议。因此，分析 COVID-19 初次疫苗接种后的长期体液免疫反应，并评估血液透析（HD）患者加强剂量的免疫原性和安全性至关重要。
方法
接受科兴（Sinovac）疫苗初次疫苗接种的维持性血液透析患者接受 BNT162b2（辉瑞-生物科技）作为加强剂量。在初次接种前（V1）、接种后一个月（V2）、八个月（V3）以及加强接种后一个月（V4）评估免疫原性。在加强接种后一个月对患者进行随访，以评估不良反应（AE）。
结果
初次接种 8 个月后，抗 SARS-CoV-2 S-RBD IgG 抗体的几何平均滴度（GMT）显著升高至 5,296.63（95%CI：2,930.89-9,571.94）U/mL（p < 0.0001），与初次接种前相比。加强接种后 1 个月，GMT 也显著升高至 19,142.56（95%CI：13,489.63-27,227.01）U/mL（p < 0.0001）。同时，初次接种后 8 个月和加强接种后 1 个月的中和抗体（NAb）抑制率中位数无显著差异（p > 0.9999）。加强接种后最常见的不良反应包括注射部位轻度疼痛（55.26%）、轻度疲劳（10.53%）和注射部位肿胀（10.53%）。未报告严重不良反应。
结论
大多数接受血液透析的 ESKD 患者对 BNT162b2 加强疫苗接种产生了良好的抗体反应，不良反应可耐受。
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