Intradermal Versus Intramuscular Hepatitis B Vaccination in Hemodialysis Patients: A Prospective Open-Label Randomized Controlled Trial in Nonresponders to Primary Vaccination
Intradermal Versus Intramuscular Hepatitis B Vaccination in Hemodialysis Patients: A Prospective Open-Label Randomized Controlled Trial in Nonresponders to Primary Vaccination
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DOI：
10.1053/j.ajkd.2009.03.010
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发表时间：
2009-07-01
影响因子：
13.2
通讯作者：
Playford, E. Geoffrey
中科院分区：
文献类型：
--
作者：
Barraclough, Katherine A.;Wiggins, Kathryn J.;Playford, E. Geoffrey
背景资料：通过肌肉注射（IM）途径接种原发性B型肝炎病毒（HBV）疫苗在透析患者中的有效性低于一般人群。先前的研究表明皮内（ID）疫苗接种可改善血清转换。研究设计：前瞻性开放标签随机对照试验。设置和参与者：对初次HBV疫苗接种无反应的血液透析患者。干预：用任一ID重新接种（每周5 μ g疫苗，持续8周）或IM结果：主要结果：在接种过程的2个月内达到HBV表面抗体（抗-HBs）滴度为10 IU/L或更高的患者比例。次要结局：血清转换时间，血清转换的预测因子，抗体滴度峰值，血清保护持续时间，疫苗的安全性和耐受性。测量：抗-HBs滴度到24个月。结果：分析了59例患者。血清转换率分别为79% ID和40% IM（P = 0.002）。ID与IM血清转换的未校正比值比为5.5（95%置信区间[CI]，1.6 - 18.4），并随着基线差异的校正而增加。血清转换的唯一预测因素是ID疫苗接种途径。ID组的几何平均峰值抗体滴度显著高于IM组：239 IU/L（95% CI，131至434）vs 78 IU/L（95% CI，36至168; P < 0.001）。ID疫苗的血清保护持续时间有延长的趋势。ID疫苗是安全的，耐受性良好。局限性：无法区分ID疫苗更有效的机制是多次注射的累积效应还是给药途径;使用抗-HBs作为保护的替代标志物;缺乏长期保护的证据。结论：与IM疫苗相比，在对主要免疫应答无反应的血液透析患者中，ID疫苗可实现显著更高的血清转换率和峰值抗体滴度。预防针ID疫苗接种应该成为这种情况下的护理标准。美国肾脏病杂志54：95-103。0 2009年由国家肾脏基金会，公司。
Background: Primary hepatitis B virus (HBV) vaccination through the intramuscular (IM) route is less efficacious in dialysis patients than in the general population. Previous studies suggest improved seroconversion with intradermai (ID) vaccination.Study Design: Prospective open-label randomized controlled trial.Setting & Participants: Hemodialysis patients nonresponsive to primary HBV vaccination.Intervention: Revaccination with either ID (5 mu g of vaccine every week for 8 weeks) or IM (40 mu g of vaccine at weeks 1 and 8) HBV vaccine.Outcomes: Primary outcome: proportion of patients achieving HBV surface antibody (anti-HBs) titer of 10 IU/L or greater within 2 months of vaccination course. Secondary outcomes: time to seroconversion, predictors of seroconversion, peak antibody titer, duration of seroprotection, and safety and tolerability of vaccine.Measurements: Anti-HBs titer to 24 months.Results: 59 patients were analyzed. Seroconversion rates were 79% ID versus 40% IM (P = 0.002). The unadjusted odds ratio for seroconversion for ID versus IM was 5.5 (95% confidence interval [CI], 1.6 to 18.4) and increased with adjustment for baseline differences. The only factor predictive of seroconversion was the ID vaccination route. The geometric mean peak antibody titer was significantly greater in the ID versus IM group: 239 IU/L (95% Cl, 131 to 434) versus 78 IU/L (95% Cl, 36 to 168; P < 0.001). There was a trend toward longer duration of seroprotection with ID vaccination. ID vaccine was safe and well tolerated.Limitations: Inability to distinguish whether the mechanism of the greater efficacy of ID vaccination was the cumulative effect of multiple injections or route of administration; use of anti-HBs as a surrogate marker of protection; lack of evidence of long-term protection.Conclusions: Significantly greater seroconversion rates and peak antibody titers can be achieved with ID compared with IM vaccination in hemodialysis patients nonresponsive to primary vaccination. ID vaccination should become the standard of care in this setting. Am J Kidney Dis 54:95-103. 0 2009 by the National Kidney Foundation, Inc.