Clinical Core

临床核心

• 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
• 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

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.

总结 VIVA临床核心B提供了支持标准化方法所需的基础设施， 入组的人类受试者的招募、纵向保留和临床表征 观察性研究核心B将通过各种活动促进以患者为中心的研究， 服务，如接触a）感染SARS-CoV-2、流感 病毒或登革热病毒，B）接受SARS-CoV-2、流感病毒和登革热病毒的免疫。 将收集受试者的生物样本和相应的临床信息， 国内和国际环境。核心B将继续进行纵向随访， 招募受试者，负责招募病毒病原体急性感染的新受试者， 兴趣它将指导西奈山伊坎医学院的生物标本收集和银行业务 （ISMMS），并将确保及时向三个不同的项目和其他两个数据分发样本 在VIVA HIPC中产生核心（免疫表型核心C和基因组核心D）。目的 1将集中在西奈山卫生系统进行的SARS-CoV-2研究的标本上 （MSHS）以及在阿根廷布宜诺斯艾利斯为项目1进行的研究。目的 2将侧重于在美国纽约MSHS进行的流感研究以及来自 为项目2在阿根廷布宜诺斯艾利斯进行的研究。目标3将侧重于来自 在约翰霍普金斯彭博学校完成登革热疫苗和挑战临床试验 公共卫生，MD，美国项目3。目标4将从Mount中获取去识别的扁桃体组织 美国纽约州ISMMS病理科西奈医院生物储存库，用于项目1， 2、项目3。目标5将确保生物样本采集时间点的协调一致， 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，确保通过实施错误生成高质量临床数据集- 核心B支持的所有研究的数据收集中的预防策略。最后 临床中心还将提供监管支持，并实施适当的人类受试者保护 措施