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

> **NIH NIH UM1** · NEW YORK UNIVERSITY SCHOOL OF MEDICINE · 2020 · $9,214,781

## Abstract

PROJECT ABSTRACT
This supplement proposal outlines the scientific agenda for the COVID-19 Prevention Network (CoVPN)
research to be carried out at the NYU VTEU. We will participate in the implementation of a COVID-19 vaccine
efficacy trial “A Phase III Randomized, Double-blind, Placebo-controlled Multicenter Study in Adults to
Determine the Safety, Efficacy, and Immunogenicity of AZD1222, A Non-replicating ChAdOx1 Vector Vaccine,
for the Prevention of COVID-19.” In addition to the above, and as a supplement request to further address the
mission of the CoVPN, we are requesting funds for other CoVPN studies “and other COVID-related research”.
We plan to conduct an additional study within the CoVPN – Monoclonal Antibody (mAb) Studies: A Phase 3,
Randomized, Double-Blind, Placebo-Controlled Study Assessing the Efficacy and Safety of Anti-Spike SARS-
CoV-2 Monoclonal Antibodies in Preventing SARS-Cov-2 Infection in Household Contacts of Individuals
Infected with SARS-CoV-2.
With the global COVID-19 pandemic, we recognize a significant need for vaccines that modify COVID-19 in
SARS-CoV-2 infected individuals. The vaccine trial we will conduct is a phase 3, placebo-controlled, double-
blinded study will test the efficacy of AZD1222, a recombinant replication-defective chimpanzee adenovirus
expressing the SARS-CoV-2 spike (S) surface glycoprotein, to modify COVID-19 disease in adults 18 year of
age and older. Participants will be recruited from up to 100 clinical trial sites across the US, using data
analytics to target high risk individuals with a diverse racial and ethnic profile.
The MAB study we will conduct is a pivotal phase 3 randomized, double-blind, placebo-controlled study in
adults with household contact exposure to individuals with SARS-CoV-2 infection in geographic areas with an
active COVID-19 outbreak. An ideal agent for prophylaxis should be fast acting and highly effective and should
protect against multiple viral variants. A monoclonal antibody (mAb) combination therapy, with two different
monoclonal antibodies that bind distinct regions of the portion of the SARS-CoV-2 spike (S) protein that bind to
and facilitate entry into host cells, has been developed in order to achieve these goals. A mAb combination
against SARS-CoV-2 for post-exposure prophylaxis that can either prevent the development of disease or
reduce viral acquisition or shedding could be key to reducing transmission of the virus and limiting symptoms
and adverse outcomes following infection.
We also request site preparedness funds, and fund for Dr Mulligan’s role as national PI of an additional MAB
study (Lilly MAB in nursing home residents and staff, for COVID-19 prevention).

## Key facts

- **NIH application ID:** 10228783
- **Project number:** 3UM1AI148574-01S1
- **Recipient organization:** NEW YORK UNIVERSITY SCHOOL OF MEDICINE
- **Principal Investigator:** Mark Joseph Mulligan
- **Activity code:** UM1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $9,214,781
- **Award type:** 3
- **Project period:** 2020-08-21 → 2021-09-09

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10228783

## Citation

> US National Institutes of Health, RePORTER application 10228783, Establishment of the New York University Vaccine and Treatment Evaluation Unit (NYU VTEU) (3UM1AI148574-01S1). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10228783. Licensed CC0.

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