Johansen Niklas Dyrby, Modin Daniel, Nealon Joshua, Samson Sandrine, Salamand Camille, Larsen Carsten Schade, Claggett Brian L, Solomon Scott D, Landray Martin J, Gislason Gunnar H, Køber Lars, Jensen Jens Ulrik Stæhr, Sivapalan Pradeesh, Vestergaard Lasse Skafte, Valentiner-Branth Palle, Krause Tyra Grove, Biering-Sørensen Tor
Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte, Copenhagen, Denmark.
Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.
Pilot Feasibility Stud. 2022 Apr 21;8(1):87. doi: 10.1186/s40814-022-01044-w.
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.
对于65岁及以上的人群，高剂量流感疫苗比标准剂量疫苗能提供更好的流感感染防护；然而，在大多数国家，高剂量疫苗并未得到广泛应用。评估高剂量疫苗与标准剂量疫苗相比在住院率和死亡率方面的相对有效性，将有助于做出更可靠的公共卫生和成本效益估计。本研究旨在调查在丹麦利用现有的疫苗接种基础设施和丹麦全国健康登记系统进行一项比较高剂量疫苗与标准剂量疫苗的实用随机临床试验的可行性。
DANFLU - 1试验（NCT05048589）是一项实用、开放标签、活性对照随机试验，将65至79岁的丹麦公民随机分为高剂量四价流感疫苗组或标准剂量四价流感疫苗组。该研究利用一家私人疫苗接种服务提供商（丹麦医生疫苗接种服务公司）的基础设施进行招募、纳入、随机分组和疫苗接种。包括安全性监测在内的所有基线和随访数据收集工作，由丹麦哥本哈根赫勒夫和根措夫特医院的心脏病学系使用丹麦全国健康登记系统集中进行。该研究旨在在2021/2022流感季节纳入40000名参与者。主要终点涉及可行性，包括纳入的参与者数量、随机分组的平衡性以及与丹麦普通人群相比的代表性。还将评估相对疫苗效力，然而，这项可行性研究没有足够的能力来评估临床结果，并且可能受到新冠疫情的影响。
DANFLU - 1研究正在调查在丹麦利用现有基础设施和丹麦全国登记系统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，特别是对于未来可能进行的有充分效力的疫苗试验，也对于希望研究其他干预措施的试验。
Clinicaltrials.gov：NCT05048589，于2021年9月17日注册。
