高剂量流感疫苗对老年人住院治疗的有效性
High-Dose Influenza Vaccine Effectiveness against Hospitalization in Older Adults.
作者信息
Johansen Niklas Dyrby, Modin Daniel, Loiacono Matthew M, Harris Rebecca C, Dufournet Marine, Larsen Carsten Schade, Larsen Lykke, Wiese Lothar, Dalager-Pedersen Michael, Claggett Brian L, Janstrup Kira Hyldekær, Bartholdy Katja Vu, Bernholm Katrine Feldballe, Borchsenius Julie Inge-Marie Helene, Davidovski Filip Soeskov, Davodian Lise Witten, Dons Maria, Duus Lisa Steen, Espersen Caroline, Fussing Frederik Holme, Jensen Anne Marie Reimer, Landler Nino Emanuel, Langhoff Adam Cadovius Femerling, Lassen Mats Christian Højbjerg, Nielsen Anne Bjerg, Ottosen Camilla Ikast, Sengeløv Morten, Skaarup Kristoffer Grundtvig, Solomon Scott D, Landray Martin J, Gislason Gunnar H, Køber Lars, Ralfkiaer Line, Nealon Joshua, Sivapalan Pradeesh, Martel Cyril Jean-Marie, Jensen Jens Ulrik Stæhr, Biering-Sørensen Tor
机构信息
Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte, Copenhagen.
Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen.
出版信息
N Engl J Med. 2025 Aug 30. doi: 10.1056/NEJMoa2509907.
BACKGROUND
High-dose inactivated influenza vaccine has been shown to provide protection against influenza that is superior to that with the standard dose. However, data from individually randomized trials on the effectiveness of the high-dose vaccine against severe outcomes are limited.
METHODS
In this pragmatic, open-label, randomized, controlled trial conducted in Denmark during the 2022-2023, 2023-2024, and 2024-2025 influenza seasons, we assigned older adults (≥65 years of age) to receive the high dose of the inactivated influenza vaccine or the standard dose. Data collection relied on nationwide administrative health registries. The primary end point was hospitalization for influenza or pneumonia that occurred from 14 days after vaccination through May 31 of the following year.
RESULTS
Of the 332,438 participants who underwent randomization, 166,218 were assigned to receive the high-dose vaccine and 166,220 to receive the standard-dose vaccine. The mean (±SD) age of the participants was 73.7±5.8 years, and 161,538 participants (48.6%) were women. A primary end-point event occurred in 1138 participants (0.68%) in the high-dose group and in 1210 (0.73%) in the standard-dose group (relative vaccine effectiveness, 5.9%; 95.2% confidence interval [CI], -2.1 to 13.4; P = 0.14). Hospitalization for influenza occurred in 0.06% of the participants in the high-dose group and in 0.11% of those in the standard-dose group (relative vaccine effectiveness, 43.6%; 95.2% CI, 27.5 to 56.3); hospitalization for pneumonia occurred in 0.63% and 0.63%, respectively (relative effectiveness, 0.5%; 95.2% CI, -8.6 to 8.8); hospitalization for cardiorespiratory disease in 2.25% and 2.38% (relative effectiveness, 5.7%; 95.2% CI, 1.4 to 9.9); hospitalization for any cause in 9.38% and 9.58% (relative effectiveness, 2.1%; 95.2% CI, -0.1 to 4.3), and death from any cause in 0.67% and 0.66% (relative effectiveness, -2.5%; 95.2% CI, -11.6 to 5.9). The incidence of serious adverse events was similar in the two groups.
CONCLUSIONS
In this trial, a high-dose inactivated influenza vaccine did not result in a significantly lower incidence of hospitalization for influenza or pneumonia than a standard dose among older adults. (Funded by Sanofi; DANFLU-2 ClinicalTrials.gov number, NCT05517174; EU Clinical Trials Register number, 2022-500657-17-00.).
背景
高剂量灭活流感疫苗已被证明对流感的防护效果优于标准剂量疫苗。然而，关于高剂量疫苗预防严重后果有效性的个体随机试验数据有限。
方法
在2022 - 2023、2023 - 2024和2024 - 2025流感季节于丹麦进行的这项务实、开放标签、随机对照试验中，我们将老年人（≥65岁）随机分配接受高剂量灭活流感疫苗或标准剂量疫苗。数据收集依赖全国性行政健康登记处。主要终点是接种疫苗14天后至次年5月31日期间因流感或肺炎住院。
结果
在332,438名接受随机分组的参与者中，166,218人被分配接受高剂量疫苗，166,220人接受标准剂量疫苗。参与者的平均（±标准差）年龄为73.7±5.8岁，161,538名参与者（48.6%）为女性。高剂量组1138名参与者（0.68%）发生主要终点事件，标准剂量组1210名参与者（0.73%）发生该事件（相对疫苗效力为5.9%；95.2%置信区间[CI]，-2.1至13.4；P = 0.14）。高剂量组0.06%的参与者因流感住院，标准剂量组为0.11%（相对疫苗效力为43.6%；95.2% CI，27.5至56.3）；因肺炎住院的比例分别为0.63%和0.63%（相对效力为0.5%；95.2% CI，-8.6至8.8）；因心肺疾病住院的比例分别为2.25%和2.38%（相对效力为5.7%；95.2% CI，1.4至9.9）；因任何原因住院的比例分别为9.38%和9.58%（相对效力为2.1%；95.2% CI，-0.1至4.3），任何原因导致的死亡比例分别为0.67%和0.66%（相对效力为-2.5%；95.2% CI，-11.6至5.9）。两组严重不良事件发生率相似。
结论
在本试验中，对于老年人，高剂量灭活流感疫苗导致的流感或肺炎住院发生率并不显著低于标准剂量疫苗。（由赛诺菲资助；DANFLU - 2临床试验注册号，NCT05517174；欧盟临床试验注册号，2022 - 500657 - 17 - 00。）
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