School of Public Health, Shanxi Medical University, Taiyuan, China.
Center of Clinical Epidemiology and Evidence Based Medicine, Shanxi Medical University, Taiyuan, China.
Expert Rev Vaccines. 2022 Nov;21(11):1675-1682. doi: 10.1080/14760584.2022.2112951. Epub 2022 Aug 18.
Patients with chronic kidney disease (CKD) have immunological defects that result in reduced production and faster decay of anti-HBs after hepatitis B vaccination. We assessed the duration of the immunogenicity after four-standard-dose and four-triple-dose regimens among patients with CKD.
A randomized controlled trial was conducted between May 2019 and February 2020. Patients were randomly allocated to receive three or four doses of 20 µg , or four doses of 60 µg of hepatitis B vaccine. Immunogenicity was assessed for 18 months till February 2021.
Between months 7 and 18, the seroconversion rate decreased from 81.7% (58/71) to 64.3% (36/56) in IM20 × 3 group, from 93.0% (66/71) to 77.4% (41/53) in IM20 × 4 group, and from 93.2% (68/73) to 90.7% (49/54) in IM60 × 4 group. Seroconversion was higher in IM60 × 4 group than in IM20 × 3 group at month 18 ( < 0.05). In multivariate analysis, CKD patients without immune suppression or hormone therapy or patients with IM60 × 4 were more likely to have durable immunogenicity at month 18.
Patients receiving four-triple-dose regimen of hepatitis B vaccine showed improved duration of immunogenicity at the one-year follow-up.
ClinicalTrials.gov (NCT03962881).
慢性肾脏病（CKD）患者存在免疫缺陷，导致乙型肝炎疫苗接种后抗-HBs 的产生减少和更快衰减。我们评估了 CKD 患者接受四标准剂量和四三倍剂量方案后的免疫原性持续时间。
这是一项于 2019 年 5 月至 2020 年 2 月进行的随机对照试验。患者被随机分配接受 3 或 4 剂 20µg 或 4 剂 60µg 的乙型肝炎疫苗。免疫原性评估持续 18 个月，直至 2021 年 2 月。
在第 7 至 18 个月期间，IM20×3 组的血清转换率从 81.7%（58/71）下降至 64.3%（36/56），IM20×4 组从 93.0%（66/71）下降至 77.4%（41/53），而 IM60×4 组从 93.2%（68/73）下降至 90.7%（49/54）。在第 18 个月时，IM60×4 组的血清转换率高于 IM20×3 组（<0.05）。在多变量分析中，无免疫抑制或激素治疗的 CKD 患者或接受 IM60×4 治疗的患者在第 18 个月时更有可能具有持久的免疫原性。
接受乙型肝炎疫苗四倍剂量方案的患者在一年随访时显示出免疫原性持续时间的改善。
ClinicalTrials.gov（NCT03962881）。
