Fujikura Tomoyuki, Isobe Shinsuke, Oikawa Shigeru, Ishigaki Sayaka, Katahashi Naoko, Iwakura Takamasa, Ohashi Naro, Kato Akihiko, Yasuda Hideo
Internal Medicine 1, Hamamatsu University School of Medicine, 1-20-1 Handayama, Chuo-ku, Hamamatsu, Shizuoka, 431-3192, Japan.
Sanarudai Asahi Clinic, Hamamatsu, Shizuoka, Japan.
Clin Exp Nephrol. 2025 Mar 4. doi: 10.1007/s10157-025-02648-1.
Patients receiving dialysis are at an increased risk of hepatitis B virus (HBV) infection due to a compromised immune system. While HBV vaccination is recommended, the response rate to the standard vaccination regimen (3 doses of 10 µg HBV vaccine) among patients with chronic kidney disease (CKD) or receiving hemodialysis in Japan is unclear. This study evaluated the seroconversion rate, optimal timing, and CKD stage in patients receiving HBV vaccination.
In this prospective, observational study conducted from May 2021 to July 2024, patients with advanced CKD not on dialysis and those receiving maintenance hemodialysis at two centers in Japan received 3 doses of 10 µg HBV vaccine at 0, 1, and 6 months. The primary outcome was the seroconversion rate, defined as anti-HBs antibody levels of ≥10 IU/mL, measured 1-3 months after the third dose.
Overall, 113 participants (63 with non-dialysis CKD and 50 with hemodialysis CKD) were included. The seroconversion rates were 64.3% in non-dialysis patients and 54.2% in patients on hemodialysis, with no significant difference (OR = 0.62, 95% CI 0.28-1.38). Multivariate analysis adjusting for covariates showed no significant difference (OR = 0.74, 95% CI 0.29-1.91), and sensitivity analysis confirmed this finding.
The seroconversion rate of the standard HBV vaccination (3×10 µg) was not significantly different from those in non-dialysis patients with CKD. More effective vaccination strategies such as higher doses, third-generation vaccines, or vaccination at an earlier CKD stage are required to improve HBV protection in this population.
由于免疫系统受损，接受透析的患者感染乙型肝炎病毒（HBV）的风险增加。虽然推荐接种HBV疫苗，但在日本，慢性肾脏病（CKD）患者或接受血液透析的患者对标准疫苗接种方案（3剂10μg HBV疫苗）的应答率尚不清楚。本研究评估了接受HBV疫苗接种患者的血清转化率、最佳接种时间和CKD分期。
在这项于2021年5月至2024年7月进行的前瞻性观察性研究中，日本两个中心未接受透析的晚期CKD患者和接受维持性血液透析的患者在0、1和6个月时接种3剂10μg HBV疫苗。主要结局是血清转化率，定义为第三剂后1至3个月测量的抗-HBs抗体水平≥10 IU/mL。
总共纳入了113名参与者（63名非透析CKD患者和50名血液透析CKD患者）。非透析患者的血清转化率为64.3%，血液透析患者为54.2%，差异无统计学意义（OR = 0.62，95%CI 0.28-1.38）。调整协变量后的多变量分析显示差异无统计学意义（OR = 0.74，95%CI 0.29-1.91），敏感性分析证实了这一发现。
标准HBV疫苗接种（3×10μg）的血清转化率与非透析CKD患者无显著差异。需要更有效的疫苗接种策略，如更高剂量、第三代疫苗或在CKD早期阶段接种疫苗，以改善该人群的HBV防护。
