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18-64 岁医护人员重复接种四价细胞培养和重组流感疫苗对免疫原性的影响:一项随机、开放标签试验。

Effect of Repeat Vaccination on Immunogenicity of Quadrivalent Cell-Culture and Recombinant Influenza Vaccines Among Healthcare Personnel Aged 18-64 Years: A Randomized, Open-Label Trial.

机构信息

Department of Pediatrics, Baylor Scott & White Health, Temple, Texas, USA.

Department of Medical Education, Texas A & M University College of Medicine, Temple, Texas, USA.

出版信息

Clin Infect Dis. 2023 Feb 8;76(3):e1168-e1176. doi: 10.1093/cid/ciac683.

DOI:10.1093/cid/ciac683
PMID:36031405
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9907492/
Abstract

BACKGROUND

Antibody responses to non-egg-based standard-dose cell-culture influenza vaccine (containing 15 µg hemagglutinin [HA]/component) and recombinant vaccine (containing 45 µg HA/component) during consecutive seasons have not been studied in the United States.

METHODS

In a randomized trial of immunogenicity of quadrivalent influenza vaccines among healthcare personnel (HCP) aged 18-64 years over 2 consecutive seasons, HCP who received recombinant-HA influenza vaccine (RIV) or cell culture-based inactivated influenza vaccine (ccIIV) during the first season (year 1) were re-randomized the second season of 2019-2020 (year 2 [Y2]) to receive ccIIV or RIV, resulting in 4 ccIIV/RIV combinations. In Y2, hemagglutination inhibition antibody titers against reference cell-grown vaccine viruses were compared in each ccIIV/RIV group with titers among HCP randomized both seasons to receive egg-based, standard-dose inactivated influenza vaccine (IIV) using geometric mean titer (GMT) ratios of Y2 post-vaccination titers.

RESULTS

Y2 data from 414 HCP were analyzed per protocol. Compared with 60 IIV/IIV recipients, 74 RIV/RIV and 106 ccIIV/RIV recipients showed significantly elevated GMT ratios (Bonferroni corrected P < .007) against all components except A(H3N2). Post-vaccination GMT ratios for ccIIV/ccIIV and RIV/ccIIV were not significantly elevated compared with IIV/IIV except for RIV/ccIIV against A(H1N1)pdm09.

CONCLUSIONS

In adult HCP, receipt of RIV in 2 consecutive seasons or the second season was more immunogenic than consecutive egg-based IIV for 3 of the 4 components of quadrivalent vaccine. Immunogenicity of ccIIV/ccIIV was similar to that of IIV/IIV. Differences in HA antigen content may play a role in immunogenicity of influenza vaccination in consecutive seasons.

CLINICAL TRIALS REGISTRATION

NCT03722589.

摘要

背景

在美国,尚未研究过连续季节中基于非鸡蛋的标准剂量细胞培养流感疫苗(含 15 µg 血凝素 [HA]/成分)和重组疫苗(含 45 µg HA/成分)的抗体反应。

方法

在一项针对 18-64 岁医护人员(HCW)的四价流感疫苗免疫原性的随机试验中,在连续两个季节中接受重组-HA 流感疫苗(RIV)或细胞培养灭活流感疫苗(ccIIV)的 HCW 在 2019-2020 年的第二个季节(2020 年[Y2])重新随机分配接受 ccIIV 或 RIV,共产生 4 种 ccIIV/RIV 组合。在 Y2 中,比较了每个 ccIIV/RIV 组与两个季节均接受基于鸡蛋的标准剂量灭活流感疫苗(IIV)的 HCW 的血凝抑制抗体滴度,使用 Y2 后疫苗接种滴度的几何平均滴度(GMT)比值。

结果

根据方案分析了每个协议组的 414 名 HCW 的 Y2 数据。与 60 名 IIV/IIV 接受者相比,74 名 RIV/RIV 和 106 名 ccIIV/RIV 接受者对所有成分(除 A(H3N2) 外)的 GMT 比值显著升高(经 Bonferroni 校正 P <.007)。与 IIV/IIV 相比,ccIIV/ccIIV 和 RIV/ccIIV 的接种后 GMT 比值仅在 RIV/ccIIV 对 A(H1N1)pdm09 时显著升高。

结论

在成年 HCW 中,连续两个季节接受 RIV 或第二个季节接受 RIV 比连续接受基于鸡蛋的 IIV 对四价疫苗的 4 个成分中的 3 个更具免疫原性。ccIIV/ccIIV 的免疫原性与 IIV/IIV 相似。血凝素抗原含量的差异可能在连续季节流感疫苗接种的免疫原性中发挥作用。

临床试验注册

NCT03722589。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1e6b/9907492/393b06d3b3ff/ciac683f3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1e6b/9907492/b778fd5a7102/ciac683f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1e6b/9907492/83707210ea3e/ciac683f2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1e6b/9907492/393b06d3b3ff/ciac683f3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1e6b/9907492/b778fd5a7102/ciac683f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1e6b/9907492/83707210ea3e/ciac683f2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1e6b/9907492/393b06d3b3ff/ciac683f3.jpg

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