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Principal Investigator: Mark Joseph Mulligan
Organization: NEW YORK UNIVERSITY SCHOOL OF MEDICINE
Fiscal Year: 2020
Award: $9,214,781
Funding agency: National Institute of Allergy and Infectious Diseases
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).
Terms: <18 year old><18 years of age><2019 novel coronavirus><2019-nCoV><21+ years old><Abdominal Typhus><Address><Adenoviridae><Adenoviruses><Adult><Adult Human><Age-Years><Antibody Response><Antigens><Assay><Binding><Binding Proteins><Bioassay><Biologic Assays><Biological Assay><Biometrics><Biometry><Biostatistics><Blood Serum><COVID><COVID-19><COVID-19 epidemic><COVID-19 pandemic><COVID-19 vaccine><COVID19><COVID19 epidemic><COVID19 pandemic><COVID19 vaccine><Cell Body><Cell Surface Glycoproteins><Cells><Cellular Assay><Cellular Immune Function><Chimp><Chimpanzee><Clinical><Clinical Treatment Moab><Clinical Trials><CoV disease><Cohort Studies><Combined Modality Therapy><Communicable Diseases><Concurrent Studies><Data Analytics><Development><Disease><Disease Outbreaks><Disorder><Dose><Double-Blind Method><Double-Blind Study><Double-Blinded><Double-Masked Method><Double-Masked Study><ED visit><ER visit><Emergency care visit><Emergency department visit><Emergency hospital visit><Emergency room visit><Enteric Fever><Evaluation><Exposure to><Eye><Eyeball><Funding><Geographic Area><Geographic Locations><Geographic Region><Geographical Location><Goals><HIV vaccine><HIV/AIDS Vaccines><Health><Household><Immune><Immune response><Immunes><Immunity><Immunological response><Immunology><Individual><Infection><Infection Control><Infectious Disease Pathway><Infectious Diseases><Infectious Disorder><Knowledge><Laboratories><Lead><Leadership><Ligand Binding Protein><Ligand Binding Protein Gene><Malaria><Mediating><Membrane Glycoproteins><Mission><Molecular Interaction><Monoclonal Antibodies><Morbidity><Morbidity - disease rate><Multi-center studies><Multicenter Studies><Multimodal Therapy><Multimodal Treatment><New York><Nursing Homes><Outbreaks><Paludism><Pan Genus><Pan Species><Participant><Pb element><Persons><Phase><Placebos><Plasmodium Infections><Population><Preparation><Preparedness><Prevention><Prophylactic treatment><Prophylaxis><Protein Binding><Protocol><Protocols documentation><Quality Control><Randomized><Randomized Clinical Trials><Readiness><Recombinants><Research><Research Methodology><Research Methods><Risk><Role><SARS-CoV-2><SARS-CoV2><SARS-associated coronavirus 2><SARS-coronavirus-2><SARS-related coronavirus 2><Safety><Sampling><Serologic><Serological><Serum><Severe acute respiratory syndrome coronavirus 2><Severities><Sham Treatment><Site><Surface Glycoproteins><Symptoms><System><Typhoid><Typhoid Fever><Universities><Vaccines><Validation><Variant><Variation><Viral><Wuhan coronavirus><adulthood><adverse consequence><adverse outcome><age 18 years><bound protein><cell assay><clinical trial analysis><combination therapy><combined modality treatment><combined treatment><corona virus disease><corona virus disease 2019><corona virus disease 2019 epidemic><corona virus disease 2019 pandemic><corona virus disease 2019 vaccine><coronavirus disease><coronavirus disease 2019><coronavirus disease 2019 epidemic><coronavirus disease 2019 pandemic><coronavirus disease 2019 vaccine><design><designing><developmental><efficacy study><efficacy testing><efficacy trial><eighteen year old><eighteen years of age><geographic site><heavy metal Pb><heavy metal lead><high risk><host response><human immunodeficiency virus vaccine><immune function><immunogen><immunogenicity><immunoresponse><mAbs><mortality><multi-modal therapy><multi-modal treatment><neutralizing antibody><nursing home><placebo controlled study><plasmid vaccine><prevent><preventing><programs><quality assurance><racial and ethnic><racial diversity><racially diverse><randomisation><randomization><randomly assigned><recruit><response><sham therapy><social role><vaccination study><vaccination trial><vaccine study><vaccine trial><vector vaccine><viral transmission><virus transmission>