Document text
Principal Investigator: Margaret Juliana McElrath
Organization: FRED HUTCHINSON CANCER CENTER
Fiscal Year: 2022
Award: $929,677
Funding agency: National Institute of Allergy and Infectious Diseases
Abstract: With the rapid onset of the COVID-19 pandemic, we recognize there is a significant gap in knowledge in the field on the contribution of immune functions involved in preventing infection, in modifying COVID-19 disease, and in clearing viral infection. We believe the HVTN is well placed to study these gaps and rapidly deploy this information in the development of SARS-CoV-2 neutralizing vaccines and mAb therapies. In this study we propose initiating an observational cohort study of approximately 400 persons in the United States (22 trials sites) and Peru (5 sites) convalescing from SARS-CoV-2 infection. Participants will be recruited from a variety of risk groups and clinical cohorts: hospitalized vs. non-hospitalized, symptomatic vs. asymptomatic, adults between 18 and 55 years of age and those older than 55 years, and persons with high interest clinical or virologic presentations (e.g., persons who developed myocarditis/pericarditis, required intubation, had prolonged viral shedding, or who develop a positive virologic test after initially clearing the infection). Specific aims of this study include identifying serologic reactivities that differentiate SARS-CoV-2 infection from vaccination, to develop and qualify a suite of immunologic assays and reference reagents that will permit detailed interrogations of the immune response to infection, to measure SARS-CoV-2 adaptive response in key populations and risk groups, and to characterize presentations of the infection among convalescent individuals.
This initial study will tell us much about the adaptive immune responses in persons who have been infected and recovered from SARS-CoV-2 and will shed light on the role the immune system plays in successfully clearance of infection. It will improve our understanding of the dynamics and duration of responses, as well as the epitope specificity and other defining signatures, and will inform rational design and testing of preventive and therapeutic vaccines and monoclonal antibodies. In addition, this protocol will lay the groundwork for prospective studies of this infection, better defining key risk groups and knowledge gaps. Lastly, this study will prepare the network for the large number of COVID-19 vaccines now entering the clinical trial pipeline. Laboratory, statistical and operational experience in this first trial will be invaluable preparation and priming of network machinery as the HVTN prepare to roll-out several efficacy trials as part of the joint NIAID COVID Prevention Network in coming months.
Terms: <2019 novel corona virus><2019 novel coronavirus><2019-nCoV><2019-nCoV vaccine><21+ years old><Abdominal Typhus><Acute><Adult><Adult Human><Age-Years><Antigenic Determinants><Assay><Binding Determinants><Bioassay><Biologic Assays><Biological Assay><COVID><COVID crisis><COVID disease severity><COVID epidemic><COVID pandemic><COVID severity><COVID-19><COVID-19 Prevention Network><COVID-19 crisis><COVID-19 disease severity><COVID-19 epidemic><COVID-19 global health crisis><COVID-19 global pandemic><COVID-19 health crisis><COVID-19 immunity><COVID-19 infection><COVID-19 pandemic><COVID-19 public health crisis><COVID-19 severity><COVID-19 vaccine><COVID-19 virus><COVID19><COVID19 crisis><COVID19 disease severity><COVID19 epidemic><COVID19 global health crisis><COVID19 global pandemic><COVID19 health crisis><COVID19 immunity><COVID19 infection><COVID19 pandemic><COVID19 public health crisis><COVID19 severity><COVID19 vaccine><COVID19 virus><CV-19><CV19><Cellular Assay><Cellular Immune Function><Chronic><Clinical><Clinical Treatment Moab><Clinical Trials><CoV disease><CoV-2><CoV2><CoVPN><Cohort Studies><Communicable Diseases><Concurrent Studies><Development><Disease><Disorder><Drugs><Enteric Fever><Epitopes><Eye><Eyeball><Future><HIV Vaccine Trials Network><HIV vaccine><HIV/AIDS Vaccines><HVTN><Immune><Immune Markers><Immune response><Immune system><Immunes><Immunity><Immunochemical Immunologic><Immunologic><Immunologic Markers><Immunological><Immunological response><Immunologically><Immunologics><Immunology><Immunology procedure><Immunotherapeutic agent><Individual><Infection><Infection Control><Infection prevention><Infectious Disease Pathway><Infectious Diseases><Infectious Disorder><Inflammation><Intubation><Joints><Knowledge><Laboratories><Light><Malaria><Measures><Mediating><Medical><Medical History><Medication><Monoclonal Antibodies><Monoclonal Antibody Therapy><Morbidity><Morbidity - disease rate><Myocarditis><NIAID><National Institute of Allergy and Infectious Disease><Paludism><Participant><Pathologic><Pericarditis><Personal Medical History><Personal Medical History Epidemiology><Persons><Peru><Pharmaceutic Preparations><Pharmaceutical Preparations><Phase><Photoradiation><Plasmodium Infections><Play><Population><Preparation><Prevent infection><Preventative vaccine><Prevention><Preventive vaccine><Prophylactic vaccine><Prospective Studies><Protocol><Protocols documentation><Quality Control><Randomized Clinical Trials><Reagent><Research Methodology><Research Methods><Risk><Role><SARS corona virus 2><SARS-CO-V2><SARS-COVID-2><SARS-CoV-2><SARS-CoV-2 disease severity><SARS-CoV-2 epidemic><SARS-CoV-2 global health crisis><SARS-CoV-2 global pandemic><SARS-CoV-2 immunity><SARS-CoV-2 infection><SARS-CoV-2 pandemic><SARS-CoV-2 severity><SARS-CoV-2 vaccine><SARS-CoV2><SARS-CoV2 epidemic><SARS-CoV2 infection><SARS-CoV2 pandemic><SARS-CoV2 vaccine><SARS-associated corona virus 2><SARS-associated coronavirus 2><SARS-coronavirus-2><SARS-coronavirus-2 epidemic><SARS-coronavirus-2 pandemic><SARS-coronavirus-2 vaccine><SARS-related corona virus 2><SARS-related coronavirus 2><SARSCoV2><Sampling><Serology><Serology test><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 CoV 2 epidemic><Severe Acute Respiratory Syndrome CoV 2 pandemic><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 epidemic><Severe acute respiratory syndrome coronavirus 2 immunity><Severe acute respiratory syndrome coronavirus 2 infection><Severe acute respiratory syndrome coronavirus 2 pandemic><Severe acute respiratory syndrome coronavirus 2 vaccine><Severe acute respiratory syndrome related corona virus 2><Site><Specificity><System><Testing><Typhoid><Typhoid Fever><United States><VAC-TX><Vaccination><Vaccine Therapy><Vaccines><Validation><Viral Diseases><Viral Shedding><Virus><Virus Diseases><Virus Shedding><Wuhan coronavirus><adaptive immune response><adulthood><allergic/immunologic body system><allergic/immunologic organ system><cardiac inflammation><cell assay><clinical trial analysis><cohort><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 crisis><coronavirus disease 2019 disease severity><coronavirus disease 2019 epidemic><coronavirus disease 2019 global health crisis><coronavirus disease 2019 global pandemic><coronavirus disease 2019 health crisis><coronavirus disease 2019 immunity><coronavirus disease 2019 infection><coronavirus disease 2019 pandemic><coronavirus disease 2019 prevention network><coronavirus disease 2019 public health crisis><coronavirus disease 2019 severity><coronavirus disease 2019 vaccine><coronavirus disease 2019 virus><coronavirus disease crisis><coronavirus disease epidemic><coronavirus disease pandemic><coronavirus disease severity><coronavirus disease-19><coronavirus disease-19 global pandemic><coronavirus disease-19 pandemic><coronavirus disease-19 vaccine><coronavirus disease-19 virus><coronavirus infectious disease-19><design><designing><developmental><disease duration><disease length><drug/agent><efficacy study><efficacy trial><experience><hCoV19><host response><human immunodeficiency virus vaccine><illness length><immune drugs><immune function><immune system response><immune-based biomarkers><immune-based therapeutics><immunity against COVID-19><immunity against COVID19><immunity against SARS-CoV-2><immunity against Severe acute respiratory syndrome coronavirus 2><immunity against coronavirus disease 2019><immunity to COVID-19><immunity to COVID19><immunity to SARS-CoV-2><immunity to Severe acute respiratory syndrome coronavirus 2><immunity to coronavirus disease 2019><immunologic assay><immunologic assay/test><immunologic preparation><immunologic therapeutics><immunological biomarkers><immunological markers><immunoresponse><immunotherapeutics><immunotherapy agent><improved><infected with COVID-19><infected with COVID19><infected with SARS-CoV-2><infected with SARS-CoV2><infected with coronavirus disease 2019><infected with severe acute respiratory syndrome coronavirus 2><interest><mAb therapy><mAbs><mortality><nCoV2><neutralizing vaccine><pandemic><pandemic disease><prevent><preventing><programs><quality assurance><rational design><recruit><response><serology assay><severe acute respiratory syndrome coronavirus 2 disease severity><severe acute respiratory syndrome coronavirus 2 global health crisis><severe acute respiratory syndrome coronavirus 2 global pandemic><severe acute respiratory syndrome coronavirus 2 severity><social role><therapeutic vaccination><therapeutic vaccine><treatment vaccines><vaccination study><vaccination trial><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 antibodies><vaccine for novel coronavirus><vaccine for the treatment><vaccine for treatment><vaccine induced antibodies><vaccine study><vaccine trial><vaccine-induced antibodies><viral infection><virus infection><virus-induced disease>