Immuno-Serological Assays for Monitoring COVID19 in Patients with Hematologic Malignancies

我们建议开展一项为期两年的合作项目，利用11个血清学科学网络（SeroNet）机构的数据，同步数据协调工作和免疫功能低下人群的个人水平数据分析，以评估疫苗增强剂和免疫反应的有效性。我们的目标是为有关COVID-19疫苗和增强剂的公共卫生指南提供信息，以减少这些弱势群体中的SARS-CoV-2感染和严重疾病。要做到这一点，需要具有临床信息的定义明确的人群的大型数据集和能够随着大流行期间出现的新研究问题而发展的强大协作基础设施。因此，我们建议模仿NA-ACCORD策略，在北美多个地点汇集队列（https://naaccord.org）。NA-ACCORD的基础工作使他们能够在大流行期间迅速转向建立CIVET-II队列合作。为了节省时间和成本，我们提出了一个单一的汇集项目，合并来自(i)电子医疗记录和（ii）来自美国各地SeroNet站点的前瞻性队列的数据。许多SeroNet站点的合作至关重要，将使结果更广泛地推广到美国人口，包括异质性来源的调查（例如，年龄、性别、种族/民族和地理）。数据协调工作将被简化，分析将按所有站点的研究领域进行划分，以允许多个出版物同时发生。

We propose a two-year collaborative project to synchronize data harmonization efforts and analyses of individual-level data in immunocompromised populations to assess effectiveness of vaccine boosters and immune responses using data from 11 Serological Sciences Network (SeroNet) institutions. Our goal is to inform public health guidelines on COVID-19 vaccine and boosters to reduce SARS-CoV-2 infection and severe illness in these vulnerable populations. To do so requires large datasets of well-defined populations with clinical information and a robust collaborative infrastructure able to evolve as new research questions arise during the pandemic. Therefore, we propose to mimic the NA-ACCORD strategy of pooling cohorts at multiple sites in North America (https://naaccord.org). The foundational work of the NA-ACCORD enabled them to rapidly pivot to establish the CIVET-II cohort collaboration during the pandemic. To be time- and cost-efficient, we propose a single pooling project that merges data from both (i) electronic medical records as well as (ii) prospective cohorts from SeroNet sites across the U.S. The cooperation of many SeroNet sites is crucial and will allow results to be more generalizable to the wider U.S. population, including investigation of sources of heterogeneity (e.g., age, sex, race/ethnicity and geography). Data harmonization efforts will be streamlined, and analyses will be divided by research area across all sites to allow multiple publications to occur simultaneously.