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

项目摘要 年，提议成立纽约大学（NYU）疫苗和治疗评价单位（VTEU）。 对标题为“疫苗和治疗评价单位（VTEUs）（UM 1临床试验）”的RFA-AI-18-046的回复 必填）"。纽约大学VTEU将成为参加NIAID传染病的10个固定地点之一 临床研究联盟（IDCRC）。在联盟内部，这个纽约大学VTEU将与NIAID密切合作， 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，长期目标是通过临床试验保护和恢复人类健康， 创新的医学对策来对抗微生物的威胁。虽然疫苗和疫苗的重大进展 抗微生物剂导致发病率和死亡率大幅降低， 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着 扭转这些收益。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。一种更好的季节性流感疫苗， 流感疫苗是必要的，2017-18赛季美国流感死亡人数为8万人。使用 NIAID和LG，NYU VTEU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（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。的 要研究的医学对策包括：疫苗、生物制剂、治疗剂、具有预测性的生物标志物 值、设备和诊断。 纽约大学VTEU团队在这些优先传染病方面拥有丰富的专业知识和经验， 对策当需要快速解决高优先级病原体时，纽约大学VTEU已经证明， 在快速反应和激增能力方面的经验-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个主要的 医院的在这些医院和相关诊所接受治疗的各种患者（840万门诊人次 2018年住院人数为144，000人），沿着的是860万的纽约市人口（最大的 城市），是招募具有特定条件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.