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：
10265637
负责人：
Mark Joseph Mulligan
金额：
$ 682.04万
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：
2021
资助国家：
美国
起止时间：
2021-09-09 至 2022-11-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10265637
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 Biological Assay Biological Markers Biological Response Modifier Therapy 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 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.

项目概要提议建立纽约大学（NYU）疫苗和治疗评估单位（VTEU）对题为“疫苗和治疗评估单位 (VTEU)”（UM1 临床试验）的 RFA-AI-18-046 的答复 NYU VTEU 将成为参与 NIAID 传染病的 10 个固定地点之一在临床研究联盟 (IDCRC) 内，纽约大学 VTEU 将与 NIAID（NIAID）密切合作。领导小组 (LG)、其他 VTEU 以及 NIAID 支持的研究资源。纽约大学 VTEU 的广泛、长期目标是通过临床试验保护和恢复人类健康对抗微生物威胁的创新医疗对策，同时疫苗和药物方面取得重大进展。抗菌药物已导致发病率和死亡率大幅下降，新出现和重新出现的病毒威胁（例如埃博拉、寨卡、SARS、MERS、尼帕病毒、登革热）和广泛的抗菌药物耐药性威胁此外，我们仍然没有针对主要传染病的广泛有效的疫苗。疾病杀手：肺结核、疟疾和艾滋病更好的季节性流感疫苗并最终成为通用疫苗。 2017-18 年流感季节，美国有 8 万人因流感死亡，这证明了流感疫苗的必要性。 NIAID 和 LG、纽约大学 VTEU 将审查、完善和实施传染病临床研究议程。根据 RFA-AI-18-046，IDCRC 最初的优先研究领域包括：性传播感染 (STI)、疟疾和被忽视的热带疾病、呼吸道感染、肠道疾病和新出现的感染。待研究的医疗对策包括：疫苗、生物制剂、治疗方法、具有预测性的生物标志物值、设备和诊断。纽约大学 VTEU 团队在这些重点传染病和当需要快速解决高优先级病原体时，纽约大学 VTEU 已经证明了应对措施。快速响应能力和激增能力方面的经验——最佳 VTEU 的关键要素。为了加速所需疫苗的开发，控制人类感染的住院研究单位纽约大学 VTEU 医学院开发了模型（CHIM）研究，包括七个专业。这些医院和相关诊所接受不同类型的患者治疗（门诊量达 840 万人次）。 2018 年住院人数为 144,000 人），以及纽约市 860 万多元化人口（最大的美国城市），非常适合招募具有特定条件的患者和健康个体。