Establishment of the New York University Vaccine and Treatment Evaluation Unit (NYU VTEU) - DMID 21-0012
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Principal Investigator: Mark Joseph Mulligan Organization: NEW YORK UNIVERSITY SCHOOL OF MEDICINE Fiscal Year: 2021 Award: $1,341,481 Funding agency: National Institute of Allergy and Infectious Diseases PROJECT SUMMARY 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 in DMID protocol 21- 0012, “A Phase 1/2 Study of Delayed Heterologous SARS-CoV-2 Vaccine Dosing (Boost) after Receipt of EUA Vaccines.” This Phase 1/2 study will evaluate the safety, tolerability, immunogenicity of different SARS-CoV-2 vaccine delayed boost at >12 weeks. This study will be composed of two different cohorts: 1. A cohort of persons previously vaccinated with an EUA vaccine who will be boosted with a homologous or heterologous vaccine strain on a homologous or a heterologous platform; and 2. A cohort of persons who are prospectively vaccinated with EUA standard dosing and who will be available for rapid assessment of a heterologous boost at some point in the future. Terms: <2019 novel corona virus><2019 novel coronavirus><2019-nCoV><2019-nCoV vaccine><Ad vector><Adenoviral Vector><Adenovirus Vector><Adverse Experience><Adverse event><B blood cells><B cell><B cells><B-Cells><B-Lymphocytes><B-cell><BNT162b2><COVID-19 Prevention Network><COVID-19 vaccine><COVID-19 virus><COVID19 vaccine><COVID19 virus><CoV-2><CoV2><CoVPN><Dose><Evaluation><Future><Immune response><Immunological response><Messenger RNA><Moderna COVID-19 vaccine><Moderna coronavirus disease 2019 vaccine><NIAID><NIH><National Institute of Allergy and Infectious Disease><National Institutes of Health><New York><Persons><Pfizer-BioNTech COVID-19 vaccine><Pfizer-BioNTech coronavirus disease 2019 vaccine><Phase><Process><Proteins><Protocol><Protocols documentation><Research><SARS corona virus 2><SARS-CoV-2><SARS-CoV-2 vaccine><SARS-CoV2><SARS-CoV2 vaccine><SARS-associated corona virus 2><SARS-associated coronavirus 2><SARS-coronavirus-2><SARS-coronavirus-2 vaccine><SARS-related corona virus 2><SARS-related coronavirus 2><SARSCoV2><Safety><Sampling><Severe Acute Respiratory Distress Syndrome CoV 2><Severe Acute Respiratory Distress Syndrome Corona Virus 2><Severe Acute Respiratory Distress Syndrome Coronavirus 2><Severe Acute Respiratory Syndrome CoV 2><Severe Acute Respiratory Syndrome CoV 2 vaccine><Severe Acute Respiratory Syndrome-associated coronavirus 2><Severe Acute Respiratory Syndrome-related coronavirus 2><Severe acute respiratory syndrome associated corona virus 2><Severe acute respiratory syndrome corona virus 2><Severe acute respiratory syndrome coronavirus 2><Severe acute respiratory syndrome coronavirus 2 vaccine><Severe acute respiratory syndrome related corona virus 2><T cell response><United States National Institutes of Health><Universities><Vaccinated><Vaccination><Vaccines><Variant><Variation><Wuhan coronavirus><access to vaccination><access to vaccines><adeno vector><adenovector><booster vaccine><cohort><corona virus disease 2019 vaccine><coronavirus disease 2019 prevention network><coronavirus disease 2019 vaccine><coronavirus disease 2019 virus><design><designing><hCoV19><host response><immune system response><immunogenicity><immunoresponse><mRNA><mRNA-1273><mRNA1273><nCoV2><prospective><trial design><vaccination access><vaccination availability><vaccine access><vaccine against 2019-nCov><vaccine against SARS-CoV-2><vaccine against SARS-CoV2><vaccine against SARS-coronavirus-2><vaccine against Severe Acute Respiratory Syndrome CoV 2><vaccine against Severe acute respiratory syndrome coronavirus 2><vaccine availability><vaccine for novel coronavirus>