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随机免疫原性试验比较了 2019-2020 年重组和基于鸡蛋的流感疫苗在以色列经常接种疫苗的医护人员中的效果。

Randomised immunogenicity trial comparing 2019-2020 recombinant and egg-based influenza vaccines among frequently vaccinated healthcare personnel in Israel.

机构信息

Influenza Division, Centers for Disease Control and Prevention, Atlanta, Georgia, USA.

Rabin Medical Center, Clalit Health Services, Beilinson Campus, Petah Tikva, Israel.

出版信息

Int J Infect Dis. 2024 Dec;149:107260. doi: 10.1016/j.ijid.2024.107260. Epub 2024 Oct 10.

DOI:10.1016/j.ijid.2024.107260
PMID:39395753
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11883642/
Abstract

OBJECTIVES

Trivalent inactivated influenza vaccine effectiveness was low in a prospective cohort of healthcare personnel (HCP) in Israel from 2016 to 2019. We conducted a randomised immunogenicity trial of quadrivalent recombinant influenza vaccine (RIV4) and standard-dose inactivated influenza vaccine (IIV4) among frequently and infrequently vaccinated previous cohort participants.

METHODS

From October 2019 to January 2020, we enrolled and randomly allocated HCP from two Israeli hospitals to receive IIV4 or RIV4. Hemagglutination inhibition (HAI) antibody titres against 2019-2020 vaccine reference influenza viruses were compared between vaccine groups using geometric mean titre (GMT) ratios from sera collected one-month post-vaccination and by frequency of vaccination in the past 5 years (>2 vs ≤2).

RESULTS

Among 415 HCP, the GMT ratio comparing RIV4 to IIV4 was 2.0 (95% confidence interval [CI] 1.7-2.7) for A(H1N1)pdm09, 1.6 (95% CI: 1.3-1.9) for A(H3N2), 1.8 (95% CI: 1.4-2.2) for B(Yamagata), and 1.1 (95% CI: 0.9-1.4) for B(Victoria). Similarly, RIV4 elicited higher HAI titres than IIV4 against all 2019-2020 vaccine reference viruses except B(Victoria) among infrequently and frequently vaccinated HCP (lower bound of GMT ratio 95% CIs ≥1.0).

CONCLUSION

RIV4 had improved immunogenicity for influenza vaccine strains among both infrequent and frequent vaccinees compared to standard-dose IIV4.

CLINICAL TRIALS REGISTRATION

NCT04523324.

摘要

目的

在 2016 年至 2019 年期间，以色列一项针对医护人员（HCP）的前瞻性队列研究表明，三价灭活流感疫苗的有效性较低。我们在之前队列中经常和不常接种疫苗的参与者中进行了四价重组流感疫苗（RIV4）和标准剂量灭活流感疫苗（IIV4）的随机免疫原性试验。

方法

2019 年 10 月至 2020 年 1 月，我们招募并随机分配来自以色列两家医院的 HCP 接受 IIV4 或 RIV4。通过接种后一个月采集的血清中和抗体滴度（HAI）与过去 5 年中接种疫苗的频率（>2 次与≤2 次），比较疫苗组之间针对 2019-2020 年疫苗参考流感病毒的血凝抑制（HAI）抗体滴度，比较疫苗组之间的几何平均滴度（GMT）比值。

结果

在 415 名 HCP 中，RIV4 与 IIV4 相比，A（H1N1）pdm09 的 GMT 比值为 2.0（95%置信区间 [CI]：1.7-2.7），A（H3N2）为 1.6（95% CI：1.3-1.9），B（Yamagata）为 1.8（95% CI：1.4-2.2），B（Victoria）为 1.1（95% CI：0.9-1.4）。同样，RIV4 比 IIV4 更能诱导 HAI 针对所有 2019-2020 年疫苗参考病毒的高滴度，除了 B（Victoria），在不常和常接种疫苗的 HCP 中（GMT 比值的下限 95%CI≥1.0）。

结论

与标准剂量 IIV4 相比，RIV4 可提高不常和经常接种疫苗者的流感疫苗株的免疫原性。

临床试验注册

NCT04523324。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7efe/11883642/72d89b9b1dcb/nihms-2057069-f0002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7efe/11883642/be4e184c7a20/nihms-2057069-f0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7efe/11883642/72d89b9b1dcb/nihms-2057069-f0002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7efe/11883642/be4e184c7a20/nihms-2057069-f0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7efe/11883642/72d89b9b1dcb/nihms-2057069-f0002.jpg

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