Immunogenicity of an adjuvanted 2009 pandemic influenza A (H1N1) vaccine in haemodialysed patients
Immunogenicity of an adjuvanted 2009 pandemic influenza A (H1N1) vaccine in haemodialysed patients
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DOI：
10.1093/ndt/gfq782
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发表时间：
2011-04-01
影响因子：
6.1
通讯作者：
Goubau, Patrick
中科院分区：
文献类型：
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作者：
Labriola, Laura;Hombrouck, Anneleen;Goubau, Patrick
背景2009年甲型流感（H1N1）大流行促使全球紧急开展疫苗接种活动，特别是针对高风险受试者，如维持性血液透析（HD）患者。然而，大流行性A（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价佐剂甲型流感/加州/2009（H1N1）疫苗（Pandemrix（R），GSK Biologicals，Rixen-sart，比利时）在HD患者和对照中的免疫原性。使用血清中和试验在单次3.75 μ g疫苗剂量之前（D-0）和之后30天（D-30）测量抗体水平。一式四份检测标本。在D-0和D-30测定每例受试者的几何平均（GM）抗体滴度。血清转化定义为GM滴度增加4倍或更多。分析了53例成人HD患者[年龄71 ± 10岁，58.5%为男性，接受HD治疗的中位时间为38（3 - 146）个月]和32例对照受试者（年龄47.3 ± 14岁，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]。在30例（93.8%）对照和34例（64.2%）HD患者中观察到血清转换（p = 0.002）。此外，对照组D-30时的GM滴度显著高于HD患者[373（217 - 640）vs 75.5（42.5 - 134）; p = 0.001]。HD患者明显比对照组年龄大（p < 0.001），更可能是男性（p = 0.02）。然而，通过多变量分析，HD状态[OR 0.13（0.02-0.78），p = 0.03]与血清转换独立相关，但年龄[OR 0.99（0.96 - 1.03）; p = 0.7]和男性性别[OR 1.31（0.45 - 3.85）; p = 0.63]均与血清转换无关。HD患者对疫苗的耐受性普遍良好。只有64%的慢性HD患者在单剂含佐剂的甲型H1N1流感疫苗后发生血清转换，这一比例远低于对照组（94%）。这些结果强调了与终末期肾病相关的实质性免疫缺陷。保护性抗体的持久性以及加强剂量的作用仍有待于在HD患者中研究。
Background. 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.Methods. We prospectively studied the immunogenicity of a monovalent adjuvanted influenza A/California/2009 (H1N1) vaccine (Pandemrix (R), GSK Biologicals, Rixen-sart, 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 mu g 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.Results. 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.Conclusions. 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.