成人实体器官移植受者中高剂量与标准剂量流感疫苗的双盲、随机试验。

A Double-Blind, Randomized Trial of High-Dose vs Standard-Dose Influenza Vaccine in Adult Solid-Organ Transplant Recipients.

机构信息

Multi Organ Transplant Program, University Health Network, University of Toronto, Ontario, Canada.

Public Health England, London, United Kingdom.

出版信息

Clin Infect Dis. 2018 May 17;66(11):1698-1704. doi: 10.1093/cid/cix1082.

DOI:10.1093/cid/cix1082

PMID:29253089

Abstract

BACKGROUND

The annual standard-dose (SD) influenza vaccine has suboptimal immunogenicity in solid organ transplant recipients (SOTRs). Influenza vaccine that contains higher doses of antigens may lead to greater immunogenicity in this population.

METHODS

We conducted a randomized, double-blind trial to compare the safety and immunogenicity of the 2016-2017 high-dose (HD; FluzoneHD, Sanofi) vs SD (Fluviral, GSK) influenza vaccine in adult SOTRs. Preimmunization and 4-week postimmunization sera underwent strain-specific hemagglutination inhibition assay.

RESULTS

We enrolled 172 patients who received study vaccine, and 161 (84 HD; 77 SD) were eligible for analysis. Seroconversion to at least 1 of 3 vaccine antigens was present in 78.6% vs 55.8% in HD vs SD vaccine groups (P < .001), respectively. Seroconversions to A/ H1N1, A/H3N2, and B strains were 40.5% vs 20.5%, 57.1% vs 32.5%, and 58.3% vs 41.6% in HD vs SD vaccine groups (P = .006, P = .002, P = .028, respectively). Post-immunization geometric mean titers of A/H1N1, A/H3N2, and B strains were significantly higher in the HD group (P = .007, P = .002, P = .033). Independent factors associated with seroconversion to at least 1 vaccine strain were the use of HD vaccine (odds ratio [OR], 3.23; 95% confidence interval [CI], 1.56-6.67) and use of mycophenolate doses <2 g daily (OR, 2.76; 95% CI, 1.12-6.76).

CONCLUSIONS

HD vaccine demonstrated significantly better immunogenicity than SD vaccine in adult transplant recipients and may be the preferred influenza vaccine for this population.

CLINICAL TRIALS REGISTRATION

NCT03139565.

摘要

背景

标准剂量（SD）流感疫苗在实体器官移植受者（SOTR）中的免疫原性并不理想。含有更高剂量抗原的流感疫苗可能会在该人群中产生更大的免疫原性。

方法

我们进行了一项随机、双盲试验，比较了 2016-2017 年高剂量（HD；FluzoneHD，赛诺菲）与 SD（Fluviral，葛兰素史克）流感疫苗在成年 SOTR 中的安全性和免疫原性。在接种前和接种后 4 周采集血清进行株特异性血凝抑制试验。

结果

我们共纳入了 172 名接受研究疫苗的患者，其中 161 名（84 名 HD；77 名 SD）符合分析条件。HD 组和 SD 组中至少有 1 种疫苗抗原的血清转化率分别为 78.6%和 55.8%（P<0.001）。HD 组中 A/ H1N1、A/H3N2 和 B 株的血清转化率分别为 40.5%、57.1%和 58.3%，而 SD 组分别为 20.5%、32.5%和 41.6%（P=0.006、P=0.002、P=0.028）。接种后，HD 组 A/H1N1、A/H3N2 和 B 株的几何平均滴度明显高于 SD 组（P=0.007、P=0.002、P=0.033）。与至少有 1 种疫苗株血清转化率相关的独立因素是使用 HD 疫苗（比值比[OR]，3.23；95%置信区间[CI]，1.56-6.67）和使用麦考酚酸剂量<2 g/天（OR，2.76；95%CI，1.12-6.76）。