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

IF 4.8 2区 医学 Q1 INFECTIOUS DISEASES International Journal of Infectious Diseases Pub Date : 2024-10-10 DOI:10.1016/j.ijid.2024.107260
Ashley L. Fowlkes , Alon Peretz , David Greenberg , Avital Hirsch , Emily T. Martin , Min Z. Levine , Laura Edwards , Sarah Radke , Adam S. Lauring , Jill M. Ferdinands , Chao Zhang , Young M. Yoo , Jacob Dreiher , Gabriella Newes-Adeyi , Eduardo Azziz-Baumgartner , Alicia M. Fry , Arnold S. Monto , Ran Balicer , Mark G. Thompson , Mark A. Katz
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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
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在以色列经常接种疫苗的医护人员中比较 2019-2020 年重组流感疫苗和蛋基流感疫苗的随机免疫原性试验。
背景:在2016-2019年以色列医疗保健人员(HCP)的前瞻性队列中,三价灭活流感疫苗的有效性较低。我们在经常接种和不经常接种的前队列参与者中开展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:从 2019 年 10 月到 2020 年 1 月,我们从两家以色列医院招募并随机分配了 HCP,让他们接种 IIV4 或 RIV4。使用疫苗接种后一个月采集的血清中的几何平均滴度(GMT)比值,并根据过去5年中的疫苗接种频率(>2对≤2),比较不同疫苗组之间针对2019-2020年疫苗参考流感病毒的血凝抑制(HAI)抗体滴度:在415名人类公共卫生人员中,RIV4与IIV4的GMT比值分别为:A(H1N1)pdm09为2.0(95%置信区间[CI] 1.7-2.7),A(H3N2)为1.6(95%置信区间:1.3-1.9),B(Yamagata)为1.8(95%置信区间:1.4-2.2),B(Victoria)为1.1(95%置信区间:0.9-1.4)。同样,在不经常接种和经常接种疫苗的HCP中,RIV4针对除B(Victoria)外的所有2019-2020年疫苗参考病毒引起的HAI滴度均高于IIV4(GMT比值下限95% CI≥1.0):与标准剂量IIV4相比,RIV4对不经常接种和经常接种者的流感疫苗毒株的免疫原性均有改善。
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来源期刊
CiteScore
18.90
自引率
2.40%
发文量
1020
审稿时长
30 days
期刊介绍: International Journal of Infectious Diseases (IJID) Publisher: International Society for Infectious Diseases Publication Frequency: Monthly Type: Peer-reviewed, Open Access Scope: Publishes original clinical and laboratory-based research. Reports clinical trials, reviews, and some case reports. Focuses on epidemiology, clinical diagnosis, treatment, and control of infectious diseases. Emphasizes diseases common in under-resourced countries.
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