高剂量四价流感疫苗预防老年人心血管和呼吸道疾病住院治疗的效果
High-Dose Quadrivalent Influenza Vaccine for Prevention of Cardiovascular and Respiratory Hospitalizations in Older Adults.
机构信息
Finnish Institute for Health and Welfare (THL), Tampere, Finland.
Global Clinical Development, Sanofi, Marcy L'Etoile, France.
出版信息
Influenza Other Respir Viruses. 2024 Apr;18(4):e13270. doi: 10.1111/irv.13270.
BACKGROUND
We assessed the relative vaccine effectiveness (rVE) of high-dose quadrivalent influenza vaccine (QIV-HD) versus standard-dose quadrivalent influenza vaccine (QIV-SD) in preventing respiratory or cardiovascular hospitalizations in older adults.
METHODS
FinFluHD was a phase 3b/4 modified double-blind, randomized pragmatic trial. Enrolment of 121,000 adults ≥65 years was planned over three influenza seasons (October to December 2019-2021). Participants received a single injection of QIV-HD or QIV-SD. The primary endpoint was first occurrence of an unscheduled acute respiratory or cardiovascular hospitalization (ICD-10 primary discharge J/I codes), from ≥14 days post-vaccination until May 31. The study was terminated after one season due to COVID-19; follow-up data for 2019-2020 are presented.
RESULTS
33,093 participants were vaccinated (QIV-HD, n = 16,549; QIV-SD, n = 16,544); 529 respiratory or cardiovascular hospitalizations (QIV-HD, n = 257; QIV-SD, n = 272) were recorded. The rVE of QIV-HD versus QIV-SD to prevent respiratory/cardiovascular hospitalizations was 5.5% (95% CI, -12.4 to 20.7). When prevention of respiratory and cardiovascular hospitalizations were considered separately, rVE estimates of QIV-HD versus QIV-SD were 5.4% (95% CI, -28.0 to 30.1) and 7.1% (95% CI, -15.0 to 25.0), respectively. Serious adverse reactions were <0.01% in both groups.
CONCLUSIONS
Despite insufficient statistical power due to the impact of COVID-19, rVE point estimates demonstrated a trend toward a benefit of QIV-HD over QIV-SD. QIV-HD was associated with lower respiratory or cardiovascular hospitalization rates than QIV-SD, with a comparable safety profile. Adequately powered studies conducted over multiple influenza seasons are needed to determine statistical significance of QIV-HD compared with QIV-SD against preventing respiratory and cardiovascular hospitalizations.
TRIAL REGISTRATION
ClinicalTrials.gov number: NCT04137887.
背景
我们评估了高剂量四价流感疫苗（QIV-HD）与标准剂量四价流感疫苗（QIV-SD）预防老年人呼吸道或心血管住院的相对疫苗有效性（rVE）。
方法
FinFluHD 是一项 3b/4 期改良的双盲、随机实用试验。计划在三个流感季节（2019-2021 年 10 月至 12 月）招募 121000 名≥65 岁的成年人。参与者接受了一次 QIV-HD 或 QIV-SD 的单剂量接种。主要终点是从接种后≥14 天至 5 月 31 日首次出现计划外急性呼吸道或心血管住院（ICD-10 主要出院 J/I 代码）。由于 COVID-19，该研究在一个季节后终止；报告了 2019-2020 年的数据。
结果
33093 名参与者接种了疫苗（QIV-HD，n=16549；QIV-SD，n=16544）；记录了 529 例呼吸道或心血管住院（QIV-HD，n=257；QIV-SD，n=272）。与 QIV-SD 相比，QIV-HD 预防呼吸道/心血管住院的 rVE 为 5.5%（95%CI，-12.4 至 20.7）。当分别考虑预防呼吸道和心血管住院时，与 QIV-SD 相比，QIV-HD 的 rVE 估计值分别为 5.4%（95%CI，-28.0 至 30.1）和 7.1%（95%CI，-15.0 至 25.0）。两组严重不良反应发生率均<0.01%。
结论
尽管由于 COVID-19 的影响，统计效力不足，但 rVE 点估计值表明 QIV-HD 相对于 QIV-SD 具有获益趋势。与 QIV-SD 相比，QIV-HD 与较低的呼吸道或心血管住院率相关，且具有相似的安全性特征。需要在多个流感季节进行充分的研究，以确定 QIV-HD 与 QIV-SD 预防呼吸道和心血管住院的统计学意义。
试验注册
ClinicalTrials.gov 编号：NCT04137887。
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