Feasibility of randomizing Danish citizens aged 65-79 years to high-dose quadrivalent influenza vaccine vs. standard-dose quadrivalent influenza vaccine in a pragmatic registry-based setting: rationale and design of the DANFLU-1 Trial.
Feasibility of randomizing Danish citizens aged 65-79 years to high-dose quadrivalent influenza vaccine vs. standard-dose quadrivalent influenza vaccine in a pragmatic registry-based setting: rationale and design of the DANFLU-1 Trial.
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DOI：
10.1186/s40814-022-01044-w
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发表时间：
2022-04-21
影响因子：
1.7
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中科院分区：
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对于 65 岁及以上的人群，高剂量流感疫苗比标准剂量的流感疫苗能更好地预防流感感染；然而，在大多数国家，高剂量疫苗并未得到广泛实施。评估高剂量疫苗与标准剂量疫苗相比对住院率和死亡率的相对有效性，将有助于对公共卫生和成本效益进行更稳健的估计。本研究旨在调查在丹麦进行实用随机临床试验的可行性，利用现有的疫苗接种基础设施和丹麦全国卫生登记处进行数据收集，比较高剂量与标准剂量疫苗。 DANFLU-1 试验 (NCT05048589) 是一项务实、开放标签、主动对照的随机试验，将 65-79 岁的丹麦公民随机接种高剂量四价流感疫苗或标准剂量四价流感疫苗。该研究利用私人疫苗接种提供商（Danske Lægers Vaccinations Service）的基础设施进行招募、纳入、随机化和疫苗接种。所有基线和随访数据（包括安全监测）的收集均由丹麦哥本哈根 Herlev 和 Gentofte 医院心脏病科利用丹麦全国卫生登记处集中进行。该研究旨在纳入 2021/2022 年流感季节的 40,000 名参与者。主要终点涉及可行性，包括登记的参与者数量、随机平衡以及与丹麦一般人群相比的代表性。还将评估相对疫苗有效性，但是，这项可行性研究并不支持临床结果，并且可能会受到 COVID-19 大流行的影响。 DANFLU-1 研究正在调查利用现有基础设施和丹麦全国注册中心在丹麦进行大规模实用临床试验的可行性。这将提供有价值的见解，特别是对于未来潜在的全动力疫苗试验，而且对于希望研究其他干预措施的试验也如此。 ClinicalTrials.gov：NCT05048589，于 2021 年 9 月 17 日注册。
High-dose influenza vaccines provide better protection against influenza infection than standard-dose in persons aged 65 years and above; however, in most countries, high-dose vaccines are not widely implemented. Assessing the relative effectiveness of high-dose compared to standard-dose vaccines on hospitalizations and mortality would enable more robust public health and cost-effectiveness estimates. This study aims to investigate the feasibility of conducting a pragmatic randomized clinical trial in Denmark comparing high-dose to standard-dose vaccines utilizing existing vaccination infrastructure and the Danish nationwide health registries for data collection. The DANFLU-1 trial (NCT05048589) is a pragmatic, open-label, active-controlled randomized trial randomizing Danish citizens aged 65–79 years to either high-dose quadrivalent influenza vaccine or standard-dose quadrivalent influenza vaccine. The study utilizes the infrastructure of a private vaccination provider (Danske Lægers Vaccinations Service) for recruitment, inclusion, randomization, and vaccination. All collection of baseline and follow-up data including safety monitoring is performed centrally by the Department of Cardiology at Herlev and Gentofte Hospital, Copenhagen, Denmark using the Danish nationwide health registries. The study aims to include 40,000 participants during the 2021/2022 influenza season. The primary endpoints address feasibility and include the number of participants enrolled, randomization balance, and representativeness compared to the Danish general population. Relative vaccine effectiveness will also be assessed, however, this feasibility study is not powered for clinical outcomes and may be affected by the COVID-19 pandemic. The DANFLU-1 study is investigating the feasibility of conducting a large-scale pragmatic clinical trial in Denmark utilizing existing infrastructure and the Danish nationwide registries. This will provide valuable insight, especially for potential future fully powered vaccine trials, but also for trials wishing to investigate other interventions. Clinicaltrials.gov: NCT05048589, registered September 17, 2021.