Division of Nephrology, Maggiore Hospital, IRCCS Foundation, Milano, Italy.
Vaccine. 2012 Mar 16;30(13):2295-300. doi: 10.1016/j.vaccine.2012.01.064. Epub 2012 Jan 26.
Patients with chronic kidney disease typically show an impaired immune response to hepatitis B virus vaccine compared with healthy individuals. A variety of inherited or acquired factors have been implicated in this diminished response. Some authors suggested a benefit with adjuvantation to improve the immunogenicity of existing HBV vaccines.
To evaluate the efficacy and safety of adjuvantation for hepatitis B virus vaccine in patients with chronic kidney disease.
Only prospective, randomized clinical trials (RCTs) were included. We used the random effects model of DerSimonian and Laird with heterogeneity and subgroups analyses. The primary end-point of interest was the seroprotection rate after HBV vaccination with recombinant vaccine plus adjuvants (study group) versus recombinant vaccine alone (control group).
We identified ten studies involving 1228 unique patients with chronic kidney disease. Pooling of study results did not show a significant increase in seroprotection rate among study (HBV recombinant vaccine plus adjuvants) versus control (HBV recombinant alone) patients; the pooled odds ratio of seroprotection rate was 1.47 (95% CI: 0.88; 2.46, NS). The pooled OR for seroresponse rate after HBV vaccine (adjuvanted recombinant vaccine versus recombinant vaccine alone) did not change in the subgroup of studies based on novel adjuvant systems (i.e., HBV-AS04 or HBV-AS02), the pooled OR was 2.22 (95% CI, 0.72; 6.78), NS. Q-test for heterogeneity being 10.819 (P=0.004).
Our meta-analysis showed that adjuvanted hepatitis B vaccine did not significantly improve the seroprotection rate in patients with renal insufficiency. These results do not support adjuvantation as an approach to increase the immunogenicity of existing recombinant vaccines towards HBV in this high-risk population.
与健康个体相比，慢性肾脏病患者对乙型肝炎病毒疫苗的免疫反应通常受损。多种遗传或获得性因素与这种反应减弱有关。一些作者认为佐剂可以改善现有乙型肝炎病毒疫苗的免疫原性，从而带来益处。
评估乙型肝炎病毒疫苗佐剂在慢性肾脏病患者中的疗效和安全性。
仅纳入前瞻性随机临床试验（RCT）。我们使用 DerSimonian 和 Laird 的随机效应模型进行异质性和亚组分析。主要观察终点为乙型肝炎病毒重组疫苗加佐剂（研究组）与乙型肝炎病毒重组疫苗单独接种（对照组）后的血清保护率。
我们确定了 10 项涉及 1228 例慢性肾脏病患者的研究。研究结果的汇总并未显示研究组（乙型肝炎病毒重组疫苗加佐剂）与对照组（乙型肝炎病毒重组疫苗单独）患者的血清保护率显著增加；血清保护率的汇总优势比为 1.47（95%CI：0.88；2.46，NS）。基于新型佐剂系统（即乙型肝炎病毒 AS04 或乙型肝炎病毒 AS02）的研究亚组中，乙型肝炎病毒疫苗（加佐剂的重组疫苗与重组疫苗单独）接种后的血清应答率的汇总 OR 没有改变，汇总 OR 为 2.22（95%CI，0.72；6.78），NS。异质性 Q 检验为 10.819（P=0.004）。
我们的荟萃分析表明，乙型肝炎病毒佐剂疫苗并未显著提高肾功能不全患者的血清保护率。这些结果不支持佐剂作为提高高危人群现有重组乙型肝炎病毒疫苗免疫原性的方法。
