Centre for Infectious Disease Control, National Institute for Public Health and the Environment (RIVM), Bilthoven, The Netherlands.
Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht (UMCU), Utrecht, The Netherlands.
BMJ Open. 2024 Oct 14;14(10):e085388. doi: 10.1136/bmjopen-2024-085388.
PURPOSE: VAccine Study COVID-19 (VASCO) is a cohort study with a 5-year follow-up that was initiated when COVID-19 vaccination was introduced in the Netherlands. The primary objective is to estimate real-world vaccine effectiveness (VE) of COVID-19 vaccines against SARS-CoV-2 infection in the Netherlands, overall and in four subpopulations defined by age and medical risk. PARTICIPANTS: The cohort consists of 45 547 community-dwelling participants aged 18-85 years who were included irrespective of their COVID-19 vaccination status or intention to get vaccinated. A medical risk condition is present in 4289 (19.8%) of 21 679 individuals aged 18-59 years, and in 9135 (38.3%) of 23 821 individuals aged 60-85 years. After 1 year of follow-up, 5502 participants had dropped out of the study. At inclusion and several times after inclusion, participants are asked to take a self-collected fingerprick blood sample in which nucleoprotein and spike protein receptor binding domain-specific antibody concentrations are assessed. Participants are also asked to complete monthly digital questionnaires in the first year, and 3 monthly in years 2-5, including questions on sociodemographic factors, health status, COVID-19 vaccination, SARS-CoV-2-related symptoms and testing results, and behavioural responses to COVID-19 measures. FINDINGS TO DATE: VASCO data have been used to describe VE against SARS-CoV-2 infection of primary vaccination, first and second booster and bivalent boosters, the impact of hybrid immunity on SARS-CoV-2 infection and VE against infectiousness. Furthermore, data were used to describe antibody response following vaccination and breakthrough infections and to investigate the relation between antibody response and reactogenicity. FUTURE PLANS: VASCO will be able to contribute to policy decision-making regarding future COVID-19 vaccination. Furthermore, VASCO provides an infrastructure to conduct further studies and to respond to changes in vaccination campaigns and testing policy, and new virus variants. TRIAL REGISTRATION NUMBER: NL9279.
目的：VAccine Study COVID-19（VASCO）是一项具有 5 年随访期的队列研究，于 COVID-19 疫苗在荷兰推出时启动。主要目的是估计 COVID-19 疫苗在荷兰对 SARS-CoV-2 感染的真实世界疫苗有效性（VE），总体以及按年龄和医疗风险分为四个亚组。
参与者：该队列包括 45547 名居住在社区的 18-85 岁参与者，无论其 COVID-19 疫苗接种状况或接种意愿如何，均纳入研究。在 18-59 岁的 21679 人中，有 4289 人（19.8%）存在医疗风险状况，在 60-85 岁的 23821 人中，有 9135 人（38.3%）存在医疗风险状况。随访 1 年后，有 5502 名参与者退出了研究。在纳入和纳入后的多次时间，参与者被要求采集自采指尖血样，评估核蛋白和刺突蛋白受体结合域特异性抗体浓度。参与者还被要求在第一年完成每月的数字问卷，在第二年至第五年每 3 个月完成一次，包括社会人口因素、健康状况、COVID-19 疫苗接种、SARS-CoV-2 相关症状和检测结果以及对 COVID-19 措施的行为反应等问题。
迄今为止的发现：VASCO 数据已用于描述初级接种、第一次和第二次加强针以及二价加强针对 SARS-CoV-2 感染的 VE，混合免疫对 SARS-CoV-2 感染和 VE 的影响，以及针对传染性的保护力。此外，数据还用于描述接种后的抗体反应和突破性感染，并研究抗体反应与不良反应之间的关系。
未来计划：VASCO 将能够为未来 COVID-19 疫苗接种的决策提供依据。此外，VASCO 提供了一个基础设施，能够进行进一步的研究，并对疫苗接种运动和检测政策的变化以及新的病毒变体做出反应。
试验注册编号：NL9279。
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