High-Dose vs Standard-Dose Influenza Vaccine in Chronic Kidney Disease: The DANFLU-2 Trial Subgroup Analysis.

Limited data exist on the effectiveness of high-dose inactivated influenza vaccine (HD-IIV) in persons with CKD.

关于高剂量灭活流感疫苗（HD-IIV）在CKD患者中的有效性，现有数据有限。

The purpose of this study was to assess the relative effectiveness (rVE) of HD-IIV vs standard-dose inactivated influenza vaccine (SD-IIV) against severe clinical outcomes in persons with CKD from the elderly general population.

本研究旨在评估高剂量流感疫苗(HD-IIV)与标准剂量流感疫苗(SD-IIV)在老年普通人群中患有慢性肾脏病(CKD)患者中对严重临床结果的相对有效性(rVE)。

Methods

DANFLU-2 (A Pragmatic Randomized Trial to Evaluate the Effectiveness of High-Dose Influenza Vaccine vs. Standard-Dose Influenza Vaccine in Older Adults) was a pragmatic, open-label, individually randomized trial conducted in Denmark during the 2022-2023, 2023-2024, and 2024-2025 influenza seasons with the aim of assessing the rVE of HD-IIV vs SD-IIV in an older adult general population.

DANFLU-2（一项评估高剂量流感疫苗与标准剂量流感疫苗在老年人群中有效性的实用随机试验）是一项实用、开放标签、个体随机试验，于2022-2023、2023-2024和2024-2025流感季节在丹麦进行，旨在评估高剂量流感疫苗(HD-IIV)与标准剂量流感疫苗(SD-IIV)在老年普通人群中的相对有效性(rVE)。

In this prespecified secondary analysis, we assessed the rVE against severe clinical outcomes according to the presence of CKD.

在这项预先指定的次要分析中，我们根据慢性肾脏病（CKD）的存在评估了相对疫苗效果（rVE）对严重临床结果的影响。

CKD was defined using data from laboratory registries and International Classification of Diseases-10th Revision diagnosis codes 10 years before vaccination.

CKD的定义是基于疫苗接种前10年的实验室登记数据和国际疾病分类-第十次修订版诊断代码。

Results

Among 332,438 DANFLU-2 participants (mean age 73.7 ± 5.8 years; 48.6% women), 46,788 (14.1%) had CKD at baseline.

在332,438名DANFLU-2参与者中（平均年龄73.7±5.8岁；48.6%为女性），46,788人（14.1%）在基线时患有慢性肾脏病（CKD）。

The effect of HD-IIV vs SD-IIV on hospitalization for influenza or pneumonia differed by CKD status: rVE was 16.9% (95% CI: 3.4%-28.5%) in participants with CKD vs 0.6% (95% CI: -9.6% to 9.9%) in those without CKD (P interaction = 0.046).

高剂量灭活流感疫苗（HD-IIV）与标准剂量灭活流感疫苗（SD-IIV）对因流感或肺炎住院的影响因CKD状态而异：在CKD患者中，相对疫苗效果（rVE）为16.9%（95%置信区间：3.4%-28.5%），而在无CKD患者中为0.6%（95%置信区间：-9.6%至9.9%）（P交互作用=0.046）。

Absolute risks for hospitalization for influenza or pneumonia were 1.7% with SD-IIV vs 1.3% with HD-IIV in CKD, corresponding to an absolute risk reduction of -0.29% (95% CI: -0.50% to 0.058%; number needed to treat [NNT] = 359).

在慢性肾脏病（CKD）患者中，使用标准剂量流感疫苗（SD-IIV）的流感或肺炎住院绝对风险为1.7%，而使用高剂量流感疫苗（HD-IIV）的为1.3%，绝对风险降低了-0.29%（95%置信区间：-0.50%至0.058%；每治疗人数[NTT]为359）。

For influenza hospitalizations specifically, the benefit of HD-IIV was also substantially greater in CKD: rVE 68.6% (95% CI: 46.7%-82.3%; NNT = 561) vs 30.6% (95% CI: 7.2%-48.2%; NNT =3,953) in non-CKD (P interaction = 0.0079).

对于流感住院，慢性肾脏病（CKD）患者使用高剂量流感疫苗（HD-IIV）的相对疫苗效果（rVE）显著高于非CKD患者，为68.6%（95%置信区间：46.7%-82.3%；每治疗人数[NTT]为561），而非CKD患者为30.6%（95%置信区间：7.2%-48.2%；每治疗人数[NTT]为3,953）（P交互作用 = 0.0079）。

Reductions in hospitalizations for cardiorespiratory disease, cardiovascular disease, heart failure, and laboratory-confirmed influenza were consistent regardless of CKD (all P interaction > 0.05).

无论是否存在慢性肾脏病（CKD），针对心肺疾病、心血管疾病、心力衰竭和实验室确诊的流感的住院率降低是一致的（所有P交互作用>0.05）。

Conclusions

In this prespecified analysis of DANFLU-2, including the largest CKD population ever in an individually randomized vaccine trial, we observed a benefit of HD-IIV vs SD-IIV against hospitalization for influenza or pneumonia, as well as hospitalization for influenza, with suggestion of a greater relative benefit among those with CKD.

在这项DANFLU-2的预先指定分析中，包括迄今为止在个体随机疫苗试验中最大的CKD人群，我们观察到高剂量流感疫苗（HD-IIV）与标准剂量流感疫苗（SD-IIV）相比，对于流感或肺炎住院以及仅流感住院的益处，以及在CKD患者中相对益处更大的迹象。

Furthermore, the beneficial effect of HD-IIV vs SD-IIV on multiple cardiorespiratory outcomes was consistent across participants irrespective of CKD status.

此外，无论慢性肾脏病（CKD）状态如何，高剂量流感疫苗（HD-IIV）与标准剂量流感疫苗（SD-IIV）相比，在多个心肺结果上的有益效果在参与者中是一致的。