根据虚弱评分比较高剂量与标准剂量流感疫苗预防住院和死亡的相对有效性：DANFLU-1随机试验的事后分析

Relative effectiveness of high-dose versus standard-dose influenza vaccine against hospitalizations and mortality according to frailty score: A post-hoc analysis of the DANFLU-1 randomized trial.

作者信息

Espersen Caroline, Johansen Niklas Dyrby, Modin Daniel, Janstrup Kira Hyldekær, Nealon Joshua, Samson Sandrine, Loiacono Matthew M, Harris Rebecca C, Andrew Melissa K, Larsen Carsten Schade, Jensen Anne Marie Reimer, Landler Nino Emanuel, Claggett Brian L, Solomon Scott D, Landray Martin J, Gislason Gunnar H, Køber Lars, Jensen Jens Ulrik Stæhr, Sivapalan Pradeesh, Biering-Sørensen Tor

机构信息

Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte, Copenhagen, Denmark.

Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark.

出版信息

J Infect Dis. 2025 Aug 13. doi: 10.1093/infdis/jiaf420.

DOI:10.1093/infdis/jiaf420

PMID:40796377

Abstract

BACKGROUND

Frailty is a risk factor for adverse influenza-related outcomes. We assessed the effectiveness of high-dose (HD-IIV) versus standard-dose (SD-IIV) influenza vaccination according to frailty score (FS).

METHODS

This was a post-hoc analysis of the randomized feasibility trial of HD-IIV versus SD-IIV conducted during the 2021-2022 influenza season in older adults aged 65-79 years. We assessed prespecified outcomes including hospitalizations and mortality as time to first and recurrent events. Frailty was defined according to the Hospital Frailty Risk Score.

RESULTS

Among 12,477 included participants (mean age 71.7 years, 47.1% female), 10,689 (85.7%) were categorized as having low frailty (<5 points) and 1,784 (14.3%) had intermediate or high frailty (≥5 points). HD-IIV versus SD-IIV was associated with a lower risk of first and recurrent hospitalizations for pneumonia or influenza regardless of FS (Low frailty: 22 events, HR 0.37, 95% CI 0.15- 0.96; 25 recurrent events, IRR 0.31, 95% CI 0.11- 0.84. Intermediate or high frailty: 16 events, HR 0.33, 95% CI 0.11-1.01; 18 recurrent events, IRR 0.28, 95% CI 0.09-0.92. Pinteraction 0.92 and 0.93, respectively). FS modified the association of HD-IIV versus SD-IIV with all-cause mortality (Pinteraction 0.022), with an association with reduced risk in participants with low frailty only (43 events, HR 0.26, 95% CI 0.13 to 0.55).

CONCLUSION

HD-IIV was associated with a lower risk of first and recurrent hospitalizations for pneumonia and influenza compared with SD-IIV and may be preferred for older adults irrespective of frailty status. FS modified the association of HD-IIV versus SD-IIV with all-cause mortality.

摘要

背景

衰弱是流感相关不良结局的一个风险因素。我们根据衰弱评分（FS）评估了高剂量（HD-IIV）与标准剂量（SD-IIV）流感疫苗接种的效果。

方法

这是一项对2021 - 2022年流感季节期间在65 - 79岁老年人中进行的HD-IIV与SD-IIV随机可行性试验的事后分析。我们评估了预先设定的结局，包括住院和死亡情况，并将其作为首次和复发事件的时间。衰弱根据医院衰弱风险评分来定义。

结果

在纳入的12477名参与者中（平均年龄71.7岁，47.1%为女性），10689名（85.7%）被归类为低衰弱（<5分），1784名（14.3%）有中度或高度衰弱（≥5分）。无论FS如何，HD-IIV与SD-IIV相比，肺炎或流感首次和复发住院的风险较低（低衰弱：22例事件，HR 0.37，95%CI 0.15 - 0.96；25例复发事件，IRR 0.31，95%CI 0.11 - 0.84。中度或高度衰弱：16例事件，HR 0.33，95%CI 0.11 - 1.01；18例复发事件，IRR 0.28，95%CI 0.09 - 0.92。交互作用P值分别为0.92和0.93）。FS改变了HD-IIV与SD-IIV与全因死亡率的关联（交互作用P值0.022），仅在低衰弱参与者中与降低风险相关（43例事件，HR 0.26，95%CI 0.13至0.55）。