Clinical Core

临床核心

• 批准号: 10435233
• 负责人: Viviana A Simon
• 金额: $ 28.32万
• 依托单位: ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI
• 依托单位国家: 美国
• 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/10435233
• 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 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; base; biobank; data management; follow-up; healthy volunteer; human pathogen; human subject; human subject protection; influenza virus vaccine; influenzavirus; interest; medical schools; pathogenic virus; patient oriented; recruit; sample collection; seasonal influenza; virology

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.

摘要 Viva临床核心B提供支持标准化方法所需的基础架构 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，如接触a)感染SARS-CoV-2、流感的人群 病毒或登革病毒，b)接受SARS-CoV-2、流感病毒和登革病毒免疫接种(S)。 参与者提取的生物样本和相应的临床信息将在 国内和国际环境。核心B将继续对 登记参与者，领导招募新的受病毒病原体急性感染的参与者 利息。它将指导生物标本的收集，存放在西奈山的伊坎医学院 (ISMMS)，并将确保向三个不同项目和另外两个数据及时分发样本 在Viva HIPC中产生核心(免疫表型核心C和基因组核心D)。目标 1将侧重于在西奈山卫生系统进行的SARS-CoV-2研究的样本 (MSHS)以及在阿根廷布宜诺斯艾利斯为项目1进行的研究。 2将集中于在美国纽约MSHS进行的流感研究样本以及来自 在阿根廷布宜诺斯艾利斯为项目2进行的研究。AIM 3将重点研究来自 在约翰霍普金斯大学彭博学院完成的登革热疫苗和挑战临床试验 美国马里兰州公共卫生部的项目3。AIM 4将从山上获取未识别的扁桃体组织 美国纽约ISMMS病理科的西奈医院生物库，用于项目1，项目 2和项目3。目标5将确保生物标本收集时间点和 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战略。最后， 临床核心还将提供监管支持并实施适当的人类受试者保护 措施。