Department of Nephrology, Cliniques Universitaires Saint-Luc, Université catholique de Louvain, Brussels, Belgium.
Nephrol Dial Transplant. 2011 Apr;26(4):1424-8. doi: 10.1093/ndt/gfq782. Epub 2011 Jan 27.
The 2009 pandemic of influenza A (H1N1) prompted an urgent worldwide vaccination campaign, especially of high-risk subjects, such as maintenance haemodialysis (HD) patients. Still the immunogenicity of the pandemic A (H1N1) vaccine in HD patients is unknown.
We prospectively studied the immunogenicity of a monovalent adjuvanted influenza A/California/2009 (H1N1) vaccine (Pandemrix, GSK Biologicals, Rixensart, Belgium) in HD patients and controls. Antibody level was measured using a seroneutralization assay before (D(0)) and 30 days after (D(30)) a single 3.75 μg vaccine dose. Specimens were tested in quadruplicates. Geometric mean (GM) antibody titers were determined in each subject at D(0) and D(30). Seroconversion was defined as an increase in GM titers by a factor 4 or more.
Fifty-three adult HD patients [aged 71 ± 10, 58.5% males, on HD for a median of 38 (3 - 146) months] and 32 control subjects (aged 47.3 ± 14, 31.3% males) were analyzed. Baseline GM titers were similar in HD patients and controls [7.9 (6.6 - 9.6) vs 10 (6 - 17); p = 0.69]. Seroconversion was observed in 30 (93.8%) controls and 34 (64.2%) HD patients (p = 0.002). In addition, GM titers at D(30) were significantly higher in controls than in HD patients [373 (217 - 640) vs 75.5 (42.5 - 134); p = 0.001]. HD patients were significantly older than controls (p < 0.001) and more likely to be males (p = 0.02). However, by multivariate analysis, HD status [OR 0.13 (0.02-0.78), p = 0.03], but neither age [OR 0.99 (0.96 - 1.03); p = 0.7] nor male gender [OR 1.31 (0.45 - 3.85); p = 0.63] was independently associated with seroconversion. The vaccine was generally well tolerated by HD patients.
Only 64% of chronic HD patients developed seroconversion after a single dose of adjuvanted influenza A (H1N1) vaccine, a much lower rate than in controls (94%). These results underscore the substantial immunodeficiency associated with End-Stage Renal Disease. The persistence of protective antibodies as well as the effect of a booster dose remain to be investigated in HD patients.
2009 年甲型流感（H1N1）大流行促使全球范围内紧急开展疫苗接种运动，尤其是对维持性血液透析（HD）患者等高危人群进行接种。然而，甲型流感（H1N1）疫苗在 HD 患者中的免疫原性尚不清楚。
我们前瞻性研究了单剂佐剂甲型流感/加利福尼亚/2009（H1N1）疫苗（Pandemrix，GSK 生物制品公司，里克斯桑特，比利时）在 HD 患者和对照组中的免疫原性。在单次 3.75μg 疫苗剂量前（D（0））和 30 天后（D（30））使用血清中和测定法测量抗体水平。标本进行四倍检测。在每个受试者中，D（0）和 D（30）确定几何平均（GM）抗体滴度。血清转化率定义为 GM 滴度增加 4 倍或以上。
分析了 53 名成年 HD 患者[年龄 71±10，58.5%为男性，HD 时间中位数为 38（3-146）个月]和 32 名对照者（年龄 47.3±14，31.3%为男性）。HD 患者和对照组的基线 GM 滴度相似[7.9（6.6-9.6）vs 10（6-17）；p=0.69]。30 名对照者（93.8%）和 34 名 HD 患者（64.2%）观察到血清转化率（p=0.002）。此外，对照组的 GM 滴度在 D（30）时明显高于 HD 患者[373（217-640）vs 75.5（42.5-134）；p=0.001]。HD 患者明显比对照组更年长（p<0.001），且更可能为男性（p=0.02）。然而，通过多变量分析，HD 状态[比值比 0.13（0.02-0.78），p=0.03]，而非年龄[比值比 0.99（0.96-1.03）；p=0.7]或男性性别[比值比 1.31（0.45-3.85）；p=0.63]与血清转化率独立相关。该疫苗通常可被 HD 患者良好耐受。
仅 64%的慢性 HD 患者在接种一剂佐剂甲型流感（H1N1）疫苗后发生血清转化率，这一比例远低于对照组（94%）。这些结果强调了终末期肾病相关的严重免疫缺陷。保护性抗体的持久性以及加强剂量的效果仍有待在 HD 患者中进行研究。
