Randomized Controlled Trial of High-Dose Intradermal Versus Standard-Dose Intramuscular Influenza Vaccine in Organ Transplant Recipients
Randomized Controlled Trial of High-Dose Intradermal Versus Standard-Dose Intramuscular Influenza Vaccine in Organ Transplant Recipients
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DOI：
10.1111/ajt.12149
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发表时间：
2013-04-01
影响因子：
8.8
通讯作者：
Kumar, D.
中科院分区：
文献类型：
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作者：
Baluch, A.;Humar, A.;Kumar, D.
在移植受者中，标准肌注流感疫苗的免疫原性是次优的。此外，最近的研究表明，同种异体抗体可能因接种疫苗而上调。我们评估了一种新的高剂量皮内（ID）疫苗策略。同时，我们评估了同种免疫。移植受者随机接受IM或高剂量ID疫苗。在免疫前后测定株特异性血清学和HLA同种抗体的产生。在212例可评估患者（105例IM， 107例ID）中，IM组对H1N1、H3N2和B型病毒的血清保护率分别为70.5%、63.8%和52.4%，ID组为71.0%、70.1%、63.6% （p = ns）。IM组和ID组血清1抗原转化率分别为46.7%和51.4% （p = 0.49）。移植后6个月更有可能出现缓解（53.2% vs. 19.2%; p = 0.001）。霉酚酸酯的使用与疫苗应答呈剂量依赖性负相关（p < 0.001）。某些器官亚组对乙型流感的应答率高于ID疫苗组。只有3/212（1.4%）患者检测到hla抗体产生差异，无临床后果。高剂量皮内疫苗是标准疫苗的替代品，在某些亚群中具有潜在的增强免疫原性。在这个大队列中，我们还表明季节性流感不会导致显著的同种异体抗体产生。
The immunogenicity of standard intramuscular (IM) influenza vaccine is suboptimal in transplant recipients. Also, recent studies suggest that alloantibody may be upregulated due to vaccination. We evaluated a novel high-dose intradermal (ID) vaccine strategy. In conjunction, we assessed alloimmunity. Transplant recipients were randomized to receive IM or high-dose ID vaccine. Strain-specific serology and HLA alloantibody production was determined pre- and postimmunization. In 212 evaluable patients (105 IM, 107 ID), seroprotection to H1N1, H3N2 and B strains was 70.5%, 63.8% and 52.4% in the IM group, and 71.0%, 70.1%, 63.6% in the ID group (p = ns). Seroconversion to 1 antigen was 46.7% and 51.4% in the IM and ID groups respectively (p = 0.49). Response was more likely in those 6 months posttransplant (53.2% vs. 19.2%; p = 0.001). Use of mycophenolate mofetil was inversely associated with vaccine response in a dose-dependent manner (p < 0.001). Certain organ subgroups had higher response rates for influenza B in the ID vaccine group. Differences in anti-HLA antibody production were detected in only 3/212(1.4%) patients with no clinical consequences. High-dose intradermal vaccine is an alternative to standard vaccine and has potential enhanced immunogenicity in certain subgroups. In this large cohort, we also show that seasonal influenza does not result in significant alloantibody production.