Clinical Core

临床核心

基本信息

批准号：
10595625
负责人：
Viviana A Simon
金额：
$ 27.71万
依托单位：
ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI
依托单位国家：
美国
项目类别：
财政年份：
2022
资助国家：
美国
起止时间：
2022-03-22 至 2027-02-28
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10595625
关键词：
2019-nCoV Adenovirus Vector Argentina Biological Biological Specimen Banks COVID-19 COVID-19 pandemic COVID-19 vaccination COVID-19 vaccine Clinical Clinical Data Clinical Protocols Clinical Research Collection Communicable Diseases Conduct Clinical Trials Cryopreservation Data Data Analyses Data Collection Data Set Dengue Vaccine Dengue Virus Enrollment Ensure Genomics Health system Hospitals Human Immune Immune response Immunity Immunization Immunization Programs Immunology Individual Infection Influenza Influenza vaccination Infrastructure International Lead Measures Medical Messenger RNA Mission Modality New York City Observational Study Operations Research Participant Pathology Patients Peripheral Blood Mononuclear Cell Persons Phenotype Plasma Population Prevention strategy Protocols documentation Public Health Schools Research Research Personnel SARS-CoV-2 infection Sampling Serum Services Source Specimen Standardization Time Tissues Tonsil Tonsillectomy Vaccination Viral acute infection biobank data management follow-up healthy volunteer human pathogen human subject human subject protection influenza virus vaccine influenzavirus interest medical schools participant enrollment pathogenic virus patient oriented recruit sample collection seasonal influenza virology

项目摘要

SUMMARY The VIVA Clinical Core B provides the infrastructures needs to support standardized approaches for the recruitment, longitudinal retention and clinical characterization of human subjects enrolled in observational studies. The Core B will facilitate patient centered research through activities and services such as access to populations of people who a) were infected with SARS-CoV-2, influenza virus or dengue virus, b) received immunization(s) for SARS-CoV-2, influenza virus and dengue virus. Participant derived biological specimen and corresponding clinical information will be collected in domestic as well as international settings. The Core B will continue with longitudinal follow-up of the enrolled participants, lead recruitment of new participants with acute infections by viral pathogens of interest. It will direct the biospecimen collection, banking at the Icahn School of Medicine at Mount Sinai (ISMMS) and will ensure timely sample distribution to the three different Projects and the two other data producing Cores (Immune Phenotyping Core C and Genomics Core D) within the VIVA HIPC. Aim 1 will focus on specimens from SARS-CoV-2 studies conducted in the Mount Sinai Health System (MSHS) in NY, USA as well as from studies conducted in Buenos Aires, Argentina for Project 1. Aim 2 will focus on specimens from influenza studies conducted at the MSHS in NY, USA as well as from studies conducted in Buenos Aires, Argentina for Project 2. Aim 3 will focus on specimens from completed dengue vaccine and challenge clinical trials conducted at Johns Hopkins Bloomberg School of Public Health, MD, USA for Project 3. Aim 4 will source de-identified tonsil tissues from the Mount Sinai Hospital Biorepository in the Department of Pathology at ISMMS, NY, USA, for Project 1, Project 2 and Project 3. Aim 5 will ensure harmonization of the biological specimen collection time points and banking modalities across the different study protocols. It will support the Data Management and Analysis Core E by ensuring high quality clinical datasets are generated through implementing error- prevention strategies in the data collection across all the studies supported by Core B. Lastly, the Clinical Core will also provide regulatory support and implement appropriate human subject protection measures.

概括 VIVA 临床核心 B 提供了支持标准化方法所需的基础设施纳入人类受试者的招募、纵向保留和临床特征观察性研究。核心 B 将通过活动和促进以患者为中心的研究服务，例如接触 a) 感染 SARS-CoV-2、流感的人群病毒或登革热病毒，b) 接受了 SARS-CoV-2、流感病毒和登革热病毒的免疫接种。参与者衍生的生物样本和相应的临床信息将被收集在国内和国际环境。核心B将继续纵向跟进招募参与者，领导招募患有以下病毒病原体急性感染的新参与者兴趣。它将指导西奈山伊坎医学院的生物样本收集和储存（ISMMS）并将确保及时将样本分发到三个不同的项目和其他两个数据在 VIVA HIPC 内生产核心（免疫表型核心 C 和基因组学核心 D）。目的 1 将重点关注西奈山卫生系统进行的 SARS-CoV-2 研究的标本（MSHS）在美国纽约以及在阿根廷布宜诺斯艾利斯进行的项目 1 的研究。目标 2 将重点关注在美国纽约州 MSHS 进行的流感研究以及来自项目 2 在阿根廷布宜诺斯艾利斯进行的研究。目标 3 将重点关注来自完成在约翰·霍普金斯大学彭博学院进行的登革热疫苗和挑战临床试验美国马里兰州公共卫生局的项目 3。目标 4 将从山上获取未识别的扁桃体组织美国纽约 ISMMS 病理科西奈医院生物样本库，项目 1 2 和项目 3。目标 5 将确保生物样本采集时间点和项目的协调一致不同研究方案的银行模式。它将支持数据管理和分析核心 E 通过实施错误确保生成高质量的临床数据集核心 B 支持的所有研究的数据收集中的预防策略。 Clinical Core 还将提供监管支持并实施适当的人类受试者保护措施。