Establishment of the New York University Vaccine and Treatment Evaluation Unit (NYU VTEU)

纽约大学疫苗和治疗评估中心（NYU VTEU）成立

基本信息

批准号：
10306410
负责人：
Mark Joseph Mulligan
金额：
$ 63.87万
依托单位：
NEW YORK UNIVERSITY SCHOOL OF MEDICINE
依托单位国家：
美国
项目类别：
财政年份：
2020
资助国家：
美国
起止时间：
2020-04-10 至 2026-11-30
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10306410
关键词：
AIDS/HIV problem Academic Medical Centers Acquired Immunodeficiency Syndrome Address Admission activity Adult Antibiotic Resistance Antibiotics Area Avian Influenza Award Beds Biological Assay Biological Markers Biological Products Biomedical Research Caring Censuses Cessation of life Child Childhood Cities Clinic Clinical Clinical Research Clinical Trials Clinical Trials Unit Clinics and Hospitals Communicable Diseases Communities Country Dengue Development Devices Diagnostic Disease Ebola Electronic Health Record Elements Enrollment Enteral Epitopes Evaluation Facilities and Administrative Costs Faculty Funding Health Healthcare Systems Hospitals Human Immunology Individual Infection Infectious Diseases Research Influenza A Virus, H1N1 Subtype Influenza A Virus, H5N1 Subtype Influenza A Virus, H7N9 Subtype Influenza A virus Inpatients Institutional Review Boards International Laboratories Laboratory Research Leadership Long Island Malaria Marriage Medical Research Microbial Drug Resistance Middle East Respiratory Syndrome Modeling Molecular Epidemiology Morbidity - disease rate Multi-Drug Resistance National Institute of Allergy and Infectious Disease New York New York City Norovirus Outpatients Participant Patient Care Patient Recruitments Patients Population Predictive Value Procedures Public Health Readiness Recording of previous events Reporting Research Research Activity Research Priority Research Support Resources Respiratory Tract Infections Seasons Severe Acute Respiratory Syndrome Sexually Transmitted Diseases Site Speed Study Subject Study models System Therapeutic Time Tuberculosis United States National Institutes of Health Universities Vaccination Vaccines Viral Visit Work ZIKA antimicrobial drug combat comparative demographics experience flu individual patient influenza virus vaccine innovation medical countermeasure medical schools metropolitan microbial microbial genomics microbiome mortality multiple omics neglected tropical diseases news novel novel strategies operation outreach pandemic influenza pathogen personalized medicine pharmacokinetics and pharmacodynamics priority pathogen recruit response seasonal influenza systems research universal influenza vaccine

项目摘要

PROJECT SUMMARY Establishment of New York University (NYU) Vaccine and Treatment Evaluation Unit (VTEU) is proposed in response to RFA-AI-18-046 entitled “Vaccine and Treatment Evaluation Units (VTEUs) (UM1 Clinical Trial Required)”. NYU VTEU will be one of the 10 fixed sites that will participate in the NIAID Infectious Diseases Clinical Research Consortium (IDCRC). Within the consortium, this NYU VTEU will work closely with NIAID, the Leadership Group (LG), other VTEUs, and NIAID-supported research resources. The broad, long-term objective of NYU VTEU is to protect and restore human health through clinical trials of innovative medical countermeasures to combat microbial threats. While major advances in vaccines and antimicrobial agents have resulted in large reductions in morbidity and mortality, emerging and re-emerging viral threats (e.g., Ebola, Zika, SARS, MERS, Nipah, dengue) and widespread antimicrobial drug resistance threaten to reverse these gains. Furthermore, we remain without broadly effective vaccines against the major infectious disease killers: tuberculosis, malaria, and AIDS. A better seasonal influenza vaccine and ultimately a universal influenza vaccine are needed, as evidenced by 80,000 US flu deaths during the 2017-18 season. Working with NIAID and LG, NYU VTEU will review, refine and implement the infectious diseases clinical research agenda. As per RFA-AI-18-046, the initial IDCRC priority research areas include: sexually transmitted infections (STIs), malaria and neglected tropical diseases, respiratory infections, enteric diseases, and emerging infections. The medical countermeasures to be studied include: vaccines, biologics, therapeutics, biomarkers with predictive value, devices, and diagnostics. NYU VTEU team has extensive expertise and experience with these priority infectious diseases and countermeasures. When high priority pathogens need to be addressed quickly, NYU VTEU has demonstrated experience in rapid responsiveness and surge capacity - critical elements of the optimal VTEU. Importantly, in order to speed the development of needed vaccines, an inpatient research unit for controlled human infection model (CHIM) studies has been developed at NYU VTEU. NYU School of Medicine comprises seven major hospitals. The diverse patients cared for in these hospitals and associated clinics (8.4 million outpatient visits and 144,000 inpatient admissions in 2018), along with the large diverse NYC population of 8.6 million (largest city in US), are ideal for recruitment of patients with specific conditions and healthy individuals.

项目摘要纽约大学（NYU）疫苗和治疗评估单位（VTEU）的建立。对RFA-AI-18-046的反应，标题为“疫苗和治疗评估单位（VTEUS）（UM1临床试验）必需的）。 NYU VTEU将是将参与NIAID传染病的10个固定地点之一临床研究联盟（IDCRC）。在财团内，这个纽约大学VTEU将与Niaid紧密合作领导力小组（LG），其他VTEU和NIAID支持的研究资源。 NYU VTEU的广泛，长期目标是通过临床试验来保护和恢复人类健康具有创新的医学对策来打击微生物威胁。而疫苗的重大进展和抗菌剂导致发病率和死亡率大大降低，出现和重新出现病毒威胁（例如埃博拉，Zika，Sars，Mers，Nipah，粉丝）和广泛的抗菌药物抗药性威胁扭转这些收益。此外，我们仍然没有针对主要感染性的广泛有效的疫苗疾病杀手：结核病，疟疾和艾滋病。更好的季节性影响者疫苗，最终是通用的需要流感疫苗，这是2017-18季节80,000次美国流感死亡证明的。与之合作 NYU VTEU NIAID和LG将审查，完善和实施传染病临床研究议程。根据RFA-AI-18-046，最初的IDCRC优先研究领域包括：性传播感染（STIS），疟疾和被忽视的热带疾病，呼吸道感染，肠道疾病和新兴感染。这研究的医学对策包括：疫苗，生物制剂，治疗，具有预测性的生物标志物价值，设备和诊断。 NYU VTEU团队在这些优先的传染病和对策。当需要快速解决高优先病原体时，NYU VTEU已证明具有快速响应能力和激增能力的经验 - 最佳VTEU的关键要素。重要的是，在为了加快所需疫苗的开发，该疫苗是一个受控人类感染的住院研究单元模型（CHIM）研究已在NYU VTEU开发。纽约大学医学院包括七个专业医院。在这些医院和相关诊所中照顾的潜水员患者（840万门诊就诊 2018年的144,000次住院入院）以及纽约市的大型潜水员860万人（最大的人口我们的城市）是招募特定条件和健康个体的患者的理想选择。