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Principal Investigator: Grace M Aldrovandi
Organization: UNIVERSITY OF CALIFORNIA LOS ANGELES
Fiscal Year: 2020
Award: $1,225,641
Funding agency: National Institute of Allergy and Infectious Diseases
Abstract
The novel SARS-CoV-2 is the cause of the coronavirus (CoV) disease (COVID-19) outbreak that currently pose
a serious pandemic threat to public health. A safe vaccine that rapidly induces long-lasting virus-specific immune
responses is urgently needed. The CoV spike (S) protein, a characteristic structural component of the viral
envelope, is considered a key target for vaccines against CoV infection, as we and others have previously
demonstrated for severe acute respiratory syndrome (SARS) and middle east respiratory syndrome (MERS)
CoV infections. The safety profile of non-infectious recombinant protein subunit vaccines makes them suitable
for SARS-CoV-2 vaccine candidates for preclinical testing. To develop a SARS-CoV-2 vaccine, we constructed
SARS-CoV-2-S1 subunit constructs and established an intracutaneous delivery platform using a novel,
dissolving microneedle array (MNA) that enhances the immunogenicity of these subunit vaccines in mice, as
determined by S1 specific viral titers in serum. Here, we propose to evaluate this PittCoVacc vaccine in a phase
I clinical trial through a single specific aim designed to complete ongoing IND enabling studies, any additional
parallel studies recommended by the FDA, and then to conduct a Phase 1 clinical trial in healthy volunteers.
Terms: <2019 novel coronavirus><2019-nCoV><AACTG><ACTG><AIDS Virus><AIDS clinical trial group><Acquired Immune Deficiency Syndrome Virus><Acquired Immunodeficiency Syndrome Virus><B blood cells><B cell><B cells><B-Cells><B-Lymphocytes><B-cell><Biological><Biological Markers><Blood Serum><COVID><Characteristics><China><Clinical Evaluation><Clinical Research><Clinical Study><Clinical Testing><CoV S protein><CoV disease><CoV emergence><CoV glycoprotein S><CoV spike glycoprotein><CoV spike protein><Coronaviridae Infections><Coronavirus Infections><Coronavirus glycoprotein S><Coronavirus spike protein><Coupled><Detection><Disease Outbreaks><Dose><EXTMR><Early-Stage Clinical Trials><Extramural><Extramural Activities><Foundations><Funding><Grant><HIV><HIV Seronegativities><HIV Seronegativity><HIV negative><HTLV-III Seronegativities><HTLV-III Seronegativity><Homolog of Drosophila TOLL><Human><Human Immunodeficiency Viruses><Immune response><Immunization><Immunologic Sensitization><Immunologic Stimulation><Immunological Sensitization><Immunological Stimulation><Immunological response><Immunostimulation><Investigators><LAV-HTLV-III><Ligands><Lymphadenopathy-Associated Virus><MERS corona virus><MERS coronavirus><MERS virus><MERS-CoV><Mainland China><Measures><Mice><Mice Mammals><Middle East Respiratory Syndrome Corona Virus><Middle East Respiratory Syndrome Coronavirus><Middle East Respiratory Syndrome Virus><Middle East Respiratory Syndrome-CoV><Middle Eastern Respiratory Syndrome Corona virus><Middle Eastern Respiratory Syndrome Coronavirus><Middle Eastern Respiratory Syndrome Virus><Middle Eastern Respiratory Syndrome-CoV><Mission><Modern Man><Murine><Mus><NIAID><NIH><Names><National Institute of Allergy and Infectious Disease><National Institutes of Health><Outbreaks><Participant><Persons><Phase><Phase 1 Clinical Trials><Phase I Clinical Trials><Preclinical Testing><Public Health><R-Series Research Projects><R01 Mechanism><R01 Program><Recombinant Proteins><Research><Research Grants><Research Personnel><Research Project Grants><Research Projects><Research Support><Researchers><SARS><SARS coronavirus disease><SARS-CoV disease><SARS-CoV-2><SARS-CoV2><SARS-associated coronavirus 2><SARS-coronavirus-2><SARS-related coronavirus 2><Safety><Serum><Severe Acute Respiratory Syndrome><Severe Acute Respiratory Syndrome CoV disease><Severe Acute Respiratory Syndrome coronavirus disease><Severe acute respiratory syndrome coronavirus 2><Structure><Subunit Vaccines><TLR4><TLR4 gene><Toll Homologue><United States National Institutes of Health><Vaccination><Vaccines><Viral><Virus><Virus-HIV><Wuhan coronavirus><acquired immunodeficiency syndrome clinical trial group><bio-markers><biologic marker><biomarker><clinical test><corona virus disease><coronavirus S protein><coronavirus disease><coronavirus emergence><coronavirus spike glycoprotein><design><designing><emergent CoV><emergent coronavirus><emerging CoV><emerging coronavirus><first in man><first-in-human><healthy volunteer><host response><immunogenic><immunogenicity><immunoresponse><mouse model><murine model><nCoV><new CoV><new coronavirus><new vaccines><next generation vaccines><novel><novel CoV><novel coronavirus><novel vaccines><open label><open label study><pandemic><pandemic disease><peripheral blood><phase 1 trial><phase I protocol><phase I trial><pre-clinical><pre-clinical testing><preclinical><research clinical testing><response><scRNA-seq><single cell RNA-seq><single cell RNAseq><single-cell RNA sequencing><toll-like receptor 4><vaccine candidate><vaccine evaluation><vaccine screening><vaccine testing>