Centers for Disease Control and Prevention, 1600 Clifton Road, NE, MS A-20, Atlanta, GA 30333, United States.
Vaccine. 2011 Dec 6;29(52):9618-23. doi: 10.1016/j.vaccine.2011.10.057. Epub 2011 Oct 30.
Hepatitis B vaccination is recommended for patients on hemodialysis, however, seroprotection after a primary vaccine series is suboptimum. Limited data are available on the effect of revaccination of non-responders and on persistence of immunity in this population.
Hepatitis B vaccine (40 μg/dose) was given to 77 susceptible patients on hemodialysis (0, 1, and 6 month schedule). Levels of hepatitis B surface antibody (anti-HBs) were tested ≥ 28 days after the third dose was administered, and non-responders revaccinated with an additional 3-dose series. Vaccine responders (anti-HBs ≥10 mIU/mL) were re-tested every 6 months and booster doses given as needed. Kaplan-Meier survival curve was used to estimate the probability of maintaining protective antibody level. Cox-proportional hazards models were used to assess the association between time to loss of protective antibody levels and certain explanatory variables.
Overall primary vaccine-induced response was 79.2% (95% CI 68.2%, 87.3%), including 49/77 (63.6%; 95% CI 51.8%, 74.7%) patients who received the initial primary hepatitis B vaccine series and 12/21 (57.1%; 95% CI 34.4%, 77.4%) non-responders who were revaccinated with an additional series. Among weak responders (anti-HBs level 10.0-99.9 mIU/mL), protective antibody levels persisted in 44% for 12 months post-vaccination; whereas among strong responders (anti-HBs level ≥100 mIU/mL), protective antibody levels persisted in 92% for 12 months, and 68% for 24 months post-vaccination. A weak post-vaccination response increased the risk of losing protective antibody levels (adjusted hazard ratio, 9.7; 95% confidence interval, 3.5-28.5; p<0.0001).
Revaccinating patients undergoing hemodialysis who do not respond to a primary vaccine series substantially increases the pool of protected patients. The threshold for defining hepatitis B vaccine-induced immunity should be revisited in this patient population to maximize the duration of protection.
建议为血液透析患者接种乙肝疫苗，但初次疫苗接种系列后产生的血清保护作用并不理想。关于该人群中再次接种非应答者的效果和免疫持久性的相关数据有限。
给 77 名血液透析易感患者（0、1 和 6 个月的方案）接种乙肝疫苗（40μg/剂）。在第三剂接种后≥28 天检测乙型肝炎表面抗体（抗-HBs）水平，对未应答者进行额外的 3 剂系列接种。疫苗应答者（抗-HBs≥10mIU/mL）每 6 个月复查一次，并根据需要给予加强剂量。使用 Kaplan-Meier 生存曲线估计维持保护性抗体水平的概率。使用 Cox 比例风险模型评估保护性抗体水平丢失与某些解释变量之间的关系。
初次疫苗接种诱导的总反应率为 79.2%（95%CI 68.2%，87.3%），其中 49/77（63.6%；95%CI 51.8%，74.7%）名接受初始乙肝疫苗系列接种的患者和 12/21（57.1%；95%CI 34.4%，77.4%）名接受额外系列接种的非应答者。在弱应答者（抗-HBs 水平 10.0-99.9 mIU/mL）中，接种后 12 个月内保护性抗体水平持续存在的比例为 44%；而在强应答者（抗-HBs 水平≥100 mIU/mL）中，接种后 12 个月内保护性抗体水平持续存在的比例为 92%，24 个月内为 68%。接种后弱反应增加了失去保护性抗体水平的风险（调整后的危险比为 9.7；95%置信区间，3.5-28.5；p<0.0001）。
对初次疫苗接种系列无反应的血液透析患者进行再次接种，可显著增加受保护患者的数量。应重新审视乙肝疫苗诱导免疫的定义阈值，以最大限度地延长保护时间。
