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Principal Investigator: Asuncion Mejias
Organization: ST. JUDE CHILDREN'S RESEARCH HOSPITAL
Fiscal Year: 2024
Award: $290,923
Funding agency: National Institute of Allergy and Infectious Diseases
Clinical Core
Principal Investigator: Asuncion Mejias, M.D.
Abstract
This Core will serve three main goals. First, by enrolling all patients, obtaining the human samples, and collecting
the clinical data it will simplify sample organization, data management and compliance with all regulatory aspects
of the U19. In addition, the Clinical Core will support Projects 1 and 2, by performing the viral PCR assays,
which will improve analytical performance and efficiency; and the Data Management Core, by coordinating and
sharing de-identified clinical data.
Specifically, the Core will be responsible for: 1) enrolling infants in the first 6 months of life with influenza or
SARS-CoV-2 infection, as well as healthy non-infected controls, and obtaining sequential blood and respiratory
samples pre and post influenza and COVID-19 vaccination during the first 3 years of life; 2) sample organization
and distribution between Projects (1 and 2); 3) longitudinal clinical data collection, data curation and data
transfer to the Data Management Core for data analyses and integration with all immune assays; 4) measure
influenza and SARS-CoV-2 viral loads by quantitative real-time PCR in clinical samples (nasopharyngeal swabs)
from infants with influenza or SARS-CoV-2 infection. This approach will optimize the use of resources and will
facilitate integration and synergy among all projects.
Terms: <0-11 years old><2019 novel corona virus><2019 novel coronavirus><2019-nCoV><Active Follow-up><Age><Assay><Bioassay><Biological Assay><Blood><Blood Reticuloendothelial System><COVID-19><COVID-19 infection><COVID-19 vaccination><COVID-19 virus><COVID-19 virus infection><COVID19 infection><COVID19 virus><CV-19><Child><Child Youth><Children (0-21)><Clinical><Clinical Data><Clinical Distribution><CoV-2><CoV2><Coronavirus Infectious Disease 2019><Data Analyses><Data Analysis><Data Collection><Development><Doctor of Medicine><Enrollment><Flu vaccination><Goals><Grippe><Human><Immune><Immunes><Immunology procedure><Infant><Infection><Influenza><Influenza Virus><Influenza immunization><Influenza vaccination><Life><Long-term cohort><Longitudinal cohort><Longterm cohort><M.D.><Measurement><Measures><Modern Man><Nasopharynx><Patients><Performance><Principal Investigator><Prophylactic vaccination against influenza><Research Resources><Resources><Rhinopharynx><SARS corona virus 2><SARS-CO-V2><SARS-COVID-2><SARS-CoV-2><SARS-CoV-2 infection><SARS-CoV-2 vaccination><SARS-CoV2><SARS-CoV2 infection><SARS-associated corona virus 2><SARS-associated coronavirus 2><SARS-coronavirus-2><SARS-related corona virus 2><SARS-related coronavirus 2><SARSCoV2><Sampling><Severe Acute Respiratory Coronavirus 2><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-associated coronavirus 2><Severe Acute Respiratory Syndrome-related coronavirus 2><Severe acute respiratory syndrome associated corona virus 2><Severe acute respiratory syndrome coronavirus 2><Severe acute respiratory syndrome coronavirus 2 infection><Severe acute respiratory syndrome coronavirus 2 vaccination><Severe acute respiratory syndrome related corona virus 2><Shapes><Time><Viral><Viral Burden><Viral Load><Viral Load result><Viral Respiratory Tract Infection><Wuhan coronavirus><active followup><ages><coronavirus disease 2019><coronavirus disease 2019 infection><coronavirus disease 2019 vaccination><coronavirus disease 2019 virus><coronavirus disease-19><coronavirus disease-19 virus><coronavirus infectious disease-19><curating data><data curation><data exchange><data integration><data interpretation><data management><data transfer><data transmission><developmental><enroll><flu immunisation><flu infection><flu virus infection><follow up><follow-up><followed up><followup><hCoV19><immunologic assay><immunologic assay/test><improved><infected with COVID-19><infected with COVID19><infected with SARS-CoV-2><infected with SARS-CoV2><infected with coronavirus disease 2019><infected with flu><infected with flu virus><infected with influenza><infected with influenza virus><infected with severe acute respiratory syndrome coronavirus 2><influenza infection><influenza virus infection><influenza virus vaccination><influenzavirus><kids><nCoV2><nasopharnygeal><nasopharyngeal swab><participant enrollment><patient enrollment><programs><respiratory><synergism><vaccinate against COVID-19><vaccinate against SARS-CoV-2><vaccinate against coronavirus disease 2019><vaccinate against severe acute respiratory syndrome coronavirus 2><vaccination against COVID-19><vaccination against SARS-CoV-2><vaccination against Severe acute respiratory syndrome coronavirus 2><vaccination against coronavirus disease 2019><vaccination against influenza><viral respiratory infection><youngster>