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.

Public Health Relevance

NYU VTEU provides outstanding leadership, scientific innovation, and operational excellence in conduct of high priority NIAID-supported infectious diseases clinical research. NYU VTEU performs clinical trials and clinical studies of infectious diseases to identify new approaches (e.g., vaccines, treatments, diagnostics, biologics, devices, biomarkers) to protect and restore health. NYU VTEU contributes to national preparedness for emerging public health threats through rapid responsiveness and surge capacity.

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Research Project with Complex Structure Cooperative Agreement (UM1)
Project #
1UM1AI148574-01
Application #
9873567
Study Section
Special Emphasis Panel (ZAI1)
Program Officer
Lee, Marina
Project Start
2020-04-10
Project End
2026-11-30
Budget Start
2020-04-10
Budget End
2020-11-30
Support Year
1
Fiscal Year
2020
Total Cost
Indirect Cost
Name
New York University
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
121911077
City
New York
State
NY
Country
United States
Zip Code
10016