Singh Surender, Mishra Ajay Kumar, Yachha Monika, Singh Thakur Prashant, Katiyar Harshita, Kaul Anupma, Dhiman Radha Krishna, Bhadauria Dharmendra Singh, Goel Amit
Department of Hepatology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, 226 014, India.
Department of Nephrology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, 226 014, India.
Indian J Gastroenterol. 2025 Feb;44(1):88-94. doi: 10.1007/s12664-024-01685-0. Epub 2024 Sep 19.
Hepatitis B virus (HBV) infection is common in people with chronic kidney diseases (CKD). The guidelines recommend four doses, 2.0 mL each, of HBV vaccine, given at zero, one, two and six months in these patients. However, real-life data on the effectiveness of this schedule are limited. We retrospectively reviewed the HBV vaccine response in the CKD population.
The study included adult (≥ 18 years) patients with glomerular filtration rate < 60 mL/min, if they had received four doses (each of 2.0 mL volume) of HBV vaccine and anti-HBs titer was measured at ≥ 1 month of the last dose of vaccine. Participants with hepatitis C or human immunodeficiency virus (HIV) coinfection, organ transplant recipients, active or remote malignancy or use of immunosuppressive medication were excluded. Anti-HBs antibody was measured with two different assays with their limits of detection up to 500 mIU/mL and 1000 mIU/mL. The presence of detectable anti-HBs antibody and anti-HBs titer ≥ 10 mIU/mL defined seroconversion and seroprotection, respectively.
The study included 208 patients (71.9% males; age 44 [33-55] years; CKD stage II/III/IV/V in 1.4%/7.2%/26.4%/64.9%; 46% on maintenance hemodialysis [MHD]). Overall, seroconversion and seroprotection were achieved in 174 (83.7%) and 161 (77.4%) participants and anti-HBs titer, measured three (2-8) months after the fourth dose, was 124 (12-500) mIU/mL. The median anti-HBs antibody levels at ≤ 6, 7-12, 13-24 and 24 months after the fourth doses were 116, 478, 43 and 70 mIU/mL, respectively. Age, body mass index, stage of CKD, serum albumin and dialysis status were not associated with seroprotection (p < 0.05).
A standard vaccination schedule of four 2.0 mL doses of HBV vaccine in CKD patients induces reasonably good and sustained seroprotection.
慢性肾脏病(CKD)患者中乙肝病毒(HBV)感染很常见。指南建议在这些患者中于0、1、2和6个月分别接种四剂,每剂2.0毫升的HBV疫苗。然而,关于该接种方案有效性的实际数据有限。我们回顾性分析了CKD人群中HBV疫苗的接种反应。
本研究纳入年龄≥18岁、肾小球滤过率<60毫升/分钟的成年患者,前提是他们已接种四剂(每剂2.0毫升)HBV疫苗,且在最后一剂疫苗接种≥1个月后检测了抗-HBs滴度。排除丙型肝炎或人类免疫缺陷病毒(HIV)合并感染患者、器官移植受者、现患或既往有恶性肿瘤患者或正在使用免疫抑制药物的患者。使用两种不同检测方法检测抗-HBs抗体,其检测限分别高达500 mIU/mL和1000 mIU/mL。抗-HBs抗体可检测及抗-HBs滴度≥10 mIU/mL分别定义为血清学转换和血清保护。
本研究纳入208例患者(男性占71.9%;年龄44[33 - 55]岁;CKD II/III/IV/V期患者分别占1.4%/7.2%/26.4%/64.9%;46%接受维持性血液透析[MHD])。总体而言,174例(83.7%)参与者实现了血清学转换,161例(77.4%)实现了血清保护,在第四剂疫苗接种后三(2 - 8)个月检测的抗-HBs滴度为124(12 - 500)mIU/mL。第四剂疫苗接种后≤6个月、7 - 12个月、13 - 24个月和24个月时抗-HBs抗体水平中位数分别为116、478、43和70 mIU/mL。年龄、体重指数、CKD分期、血清白蛋白和透析状态与血清保护无关(p<0.05)。
CKD患者中标准的四剂2.0毫升HBV疫苗接种方案可诱导相当良好且持续的血清保护。