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

项目总结 年提议成立纽约大学(NYU)疫苗和治疗评估股(VTEU)。 对RFA-AI-18-046《疫苗和治疗评价单位(VTEU)(UM1临床试验)》的回应 必填项)“。纽约大学VTEU将是参与NIAID传染病的10个固定地点之一 临床研究联盟(IDCRC)在该联盟内，纽约大学VTEU将与NIAID、 领导小组(LG)、其他VTEU和NIAID支持的研究资源。 纽约大学VTEU的广泛和长期目标是通过临床试验保护和恢复人类健康 应对微生物威胁的创新医学对策。虽然疫苗和疫苗方面的重大进展 抗菌剂大大降低了发病率和死亡率、新出现和重新出现的病毒 威胁(如埃博拉、寨卡、SARS、中东呼吸综合征、尼帕、登革热)和普遍的抗菌素耐药性威胁 来扭转这些涨势。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：结核病、疟疾和艾滋病。一种更好的季节性流感疫苗，并最终成为全球通用的 流感疫苗是需要的，2017-18赛季美国有8万人死于流感就证明了这一点。使用 NIAID和LG，NYU VTEU将审查、改进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， 疟疾和被忽视的热带病、呼吸道感染、肠道疾病和新发感染。这个 有待研究的医学对策包括：疫苗、生物制品、治疗学、具有预测性的生物标记物 价值、设备和诊断。 纽约大学VTEU团队在这些优先传染病和 对策。当高优先级病原体需要迅速解决时，纽约大学VTEU已经证明 在快速响应和浪涌容量方面的经验--这是最佳VTEU的关键要素。重要的是，在 为了加快所需疫苗的开发，一个控制人类感染的住院研究单位 模型(CHIM)研究已经在纽约大学VTEU开发。纽约大学医学院由七大 医院。在这些医院和相关诊所护理的不同患者(840万人次门诊 以及2018年14.4万名住院患者)，以及纽约市860万的多元化人口(最大 美国城市)是招募有特殊情况的患者和健康个体的理想选择。

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.