Document text
Principal Investigator: William Elkins
Organization: NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES
Fiscal Year: 2020
Award: $57,413
Funding agency: National Institute of Allergy and Infectious Diseases
Since April, the IDPS has received and processed lung samples from approximately 300 mice and 100 NHPs, respectively. The data generated, therein, helped move the ongoing clinical studies forward to Phase III clinical trials and, at the same time, resulted in the submission and publication of these valuable data sets in the New England Journal of Medicine and Nature (Corbett, K.S. et al. Evaluation of the mRNA-1273 Vaccine against SARS-CoV-2 in Nonhuman Primates. N. Engl. J. Med. (2020) and Corbett, K.S. et al. SARS-CoV-2 mRNA vaccine design enabled by prototype pathogen preparedness. Nature (2020). In particular, the IDPS evaluation of these respiratory tissue samples remained chiefly focused on determining whether, and to what degree, pathological changes in the lung were present with and without vaccination; determining if vaccine-associated enhanced respiratory disease (VAERD) was present; determining the quantity and location of viral antigen, viral RNA and a range of immune cell phenotypes in the lung tissues. Microscopic assessment of the tissues for these disease parameters helped clarify the in-vivo performance of the mRNA-1273 vaccine candidate and characterized the associated disease outcomes.
Terms: <2019 novel coronavirus><2019-nCoV><Animal Model><Animal Models and Related Studies><Body Tissues><COVID><COVID-19><COVID19><Cell Body><Cells><Clinical Research><Clinical Study><CoV disease><Communicable Diseases><Data><Data Set><Dataset><Disease><Disease Outcome><Disorder><Evaluation><Immune><Immune response><Immunes><Immunological response><Infection><Infectious Disease Pathway><Infectious Diseases><Infectious Disorder><Investigation><Investigators><Journals><Location><Lung><Lung Parenchyma><Lung Respiratory System><Lung Tissue><Lung diseases><Magazine><Medicine><Messenger RNA><Mice><Mice Mammals><Microscopic><Modeling><Murine><Mus><NIAID><National Institute of Allergy and Infectious Disease><Nature><New England><Northeastern United States><Pathogenesis><Pathologic><Performance><Phase 3 Clinical Trials><Phase III Clinical Trials><Phenotype><Preparedness><Process><Publications><Pulmonary Diseases><Pulmonary Disorder><Pulmonary Pathology><RNA vaccine><Readiness><Research Personnel><Researchers><Respiratory Disease><Respiratory System Disease><Respiratory System Disorder><SARS-CoV-2><SARS-CoV2><SARS-associated coronavirus 2><SARS-coronavirus-2><SARS-related coronavirus 2><Sampling><Scientific Publication><Severe acute respiratory syndrome coronavirus 2><Structure of parenchyma of lung><Time><Tissue Sample><Tissues><Vaccination><Vaccine Design><Vaccines><Viral Antigens><Wuhan coronavirus><corona virus disease><corona virus disease 2019><coronavirus disease><coronavirus disease 2019><disease of the lung><disorder of the lung><host response><immunoresponse><in vivo><lung disorder><lung pathology><mRNA><mRNA vaccine><model of animal><model organism><non-human primate><nonhuman primate><pathogen><phase III protocol><prototype><pulmonary><respiratory><safety study><vaccine candidate><viral RNA><virus RNA><virus antigen>