The following contains proprietary/privileged information that HDT Bio Corp requests not be released to persons outside the government, except for purposes of review and evaluation. PROJECT SUMMARY/ ABSTRACT Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV)-2, the cause of the COVID-19 pandemic, rapidly spread worldwide and has had, and continues to have, a devasting impact on the global economy and individual quality of life. Large scale testing and expedient testing at regional and national levels is required for improved understanding of SARS-CoV-2 infection levels to inform public health control measures and guide a return to normality. While diagnostic strategies using nucleic acid- and antibody-detection tests have emerged, practical and scientific/clinical limitations inherent to both these platforms have left testing gaps. The rapid waning of antibody titers that is a natural phenomenon common to coronavirus immunity has been reported after SARS- CoV-2 infection (3-5), limiting the capability of antibody-based tests to assess both infection and immunity. Detailed immunological evaluations are, however, now indicating that antigen-specific T cell responses generated by both symptomatic and asymptomatic SARS-CoV-2 infection are more stable and longer lasting. Thus, there is significant merit in developing commercial tests that detect antigen-specific T cell responses for integration into the overall COVID-19 epidemiology and containment strategy. The overall goal of this program is to develop a T cell-based skin test (CoroDetecTTM) to detect and assess history of SARS-CoV-2-infection. Importantly, unlike most other testing systems, we will emphasize the production of a test that has minimal components, does not require laboratory support, and provides results directly to the subject being tested. Public Health Relevance Statement The following contains proprietary/privileged information that HDT Bio Corp requests not be released to persons outside the government, except for purposes of review and evaluation. PROJECT NARRATIVE Practical tools are required to help health surveillance programs during the COVID-19 pandemic. Using the observation that antigen-specific T cell responses outlast circulating antibodies following coronavirus infections, we will develop a T cell-based skin test to detect immunity to SARS-CoV-2 infection. This practical test will address a critical gap in the fight against this devastating disease.
Project Terms: Antibodies ; Antigens ; immunogen ; Blood ; Blood Reticuloendothelial System ; Containment ; Disease ; Disorder ; Epidemiology ; epidemiologic ; epidemiological ; Exhibits ; Goals ; Government ; Health ; Recording of previous events ; History ; Delayed Hypersensitivity ; Delayed-Type Hypersensitivity ; Tuberculin-Type Hypersensitivity ; Type IV Hypersensitivity ; cell mediated hypersensitivity ; delayed-type hypersensitivity response ; Immunity ; Infection ; Laboratories ; Liposomes ; Liposomal ; Methods ; Methodology ; Persons ; Nucleic Acids ; Patients ; Phenotype ; Production ; Proteins ; Public Health ; Quality of life ; QOL ; Recombinant Proteins ; Hypersensitivity skin testing ; Skin Tests ; hypersensitivity test ; immunologic skin test ; T-Lymphocyte ; T-Cells ; thymus derived lymphocyte ; CD4 Positive T Lymphocytes ; CD4 Cells ; CD4 T cells ; CD4 helper T cell ; CD4 lymphocyte ; CD4+ T-Lymphocyte ; CD4-Positive Lymphocytes ; T4 Cells ; T4 Lymphocytes ; Technology ; Testing ; Measures ; base ; Nucleocapsid ; improved ; Procedures ; Left ; Site ; Clinical ; Phase ; Coronavirus ; Coronaviridae ; corona virus ; Coronavirus Infections ; Coronaviridae Infections ; Evaluation ; Individual ; Measurement ; tool ; Diagnostic ; programs ; Immunes ; Immune ; System ; antibody titering ; Antibody titer measurement ; Nucleocapsid Proteins ; experience ; Seroprevalences ; memory T lymphocyte ; T memory cell ; Reporting ; model development ; Normalities ; Normalcy ; Drops ; SARS ; SARS coronavirus disease ; SARS-CoV disease ; Severe Acute Respiratory Syndrome CoV disease ; Severe Acute Respiratory Syndrome coronavirus disease ; Severe Acute Respiratory Syndrome ; SARS Virus ; SARS corona virus ; SARS-Associated Coronavirus ; SARS-CoV ; SARS-Related Coronavirus ; Severe Acute Respiratory Syndrome Virus ; Severe Acute Respiratory Syndrome corona virus ; Severe Acute Respiratory Syndrome coronavirus ; severe acute respiratory syndrome-CoV ; SARS coronavirus ; Address ; Dose ; Detection ; Recombinants ; Surveillance Program ; in vivo ; Immunologics ; Immunochemical Immunologic ; Immunologic ; Immunological ; Immunologically ; Process ; Development ; developmental ; fight against ; national surveillance ; Population ; population based ; T cell response ; Antibody Response ; Formulation ; Structural Protein ; experimental study ; experiment ; experimental research ; preclinical development ; pre-clinical development ; antigen-specific T cells ; COVID-19 ; COVID19 ; CV-19 ; CV19 ; corona virus disease 2019 ; coronavirus disease 2019 ; 2019-nCoV ; 2019 novel corona virus ; 2019 novel coronavirus ; COVID-19 virus ; COVID19 virus ; CoV-2 ; CoV2 ; SARS corona virus 2 ; SARS-CoV-2 ; SARS-CoV2 ; SARS-associated corona virus 2 ; SARS-associated coronavirus 2 ; SARS-coronavirus-2 ; SARS-related corona virus 2 ; SARS-related coronavirus 2 ; SARSCoV2 ; 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 corona virus 2 ; Severe acute respiratory syndrome coronavirus 2 ; Severe acute respiratory syndrome related corona virus 2 ; Wuhan coronavirus ; coronavirus disease 2019 virus ; hCoV19 ; nCoV2 ; Middle East Respiratory Syndrome ; MERS ; MERS coronavirus disease ; MERS-CoV disease ; Middle East Respiratory Syndrome CoV disease ; Middle East Respiratory Syndrome coronavirus disease ; Middle Eastern Respiratory Syndrome ; Middle Eastern Respiratory Syndrome CoV disease ; Middle Eastern Respiratory Syndrome coronavirus disease ; COVID-19 pandemic ; COVID crisis ; COVID epidemic ; COVID pandemic ; COVID-19 crisis ; COVID-19 epidemic ; COVID-19 global health crisis ; COVID-19 global pandemic ; COVID-19 health crisis ; COVID-19 public health crisis ; COVID19 crisis ; COVID19 epidemic ; COVID19 global health crisis ; COVID19 global pandemic ; COVID19 health crisis ; COVID19 pandemic ; COVID19 public health crisis ; SARS-CoV-2 epidemic ; SARS-CoV-2 global health crisis ; SARS-CoV-2 global pandemic ; SARS-CoV-2 pandemic ; SARS-CoV2 epidemic ; SARS-CoV2 pandemic ; SARS-coronavirus-2 epidemic ; SARS-coronavirus-2 pandemic ; Severe Acute Respiratory Syndrome CoV 2 epidemic ; Severe Acute Respiratory Syndrome CoV 2 pandemic ; Severe acute respiratory syndrome coronavirus 2 epidemic ; Severe acute respiratory syndrome coronavirus 2 pandemic ; corona virus disease 2019 epidemic ; corona virus disease 2019 pandemic ; coronavirus disease 2019 crisis ; coronavirus disease 2019 epidemic ; coronavirus disease 2019 global health crisis ; coronavirus disease 2019 global pandemic ; coronavirus disease 2019 health crisis ; coronavirus disease 2019 pandemic ; coronavirus disease 2019 public health crisis ; coronavirus disease crisis ; coronavirus disease epidemic ; coronavirus disease pandemic ; severe acute respiratory syndrome coronavirus 2 global health crisis ; severe acute respiratory syndrome coronavirus 2 global pandemic ; coronavirus disease ; COVID ; CoV disease ; corona virus disease ; SARS-CoV-2 immunity ; COVID-19 immunity ; COVID19 immunity ; Severe acute respiratory syndrome coronavirus 2 immunity ; coronavirus disease 2019 immunity ; 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 ; antibody test ; antibody based test ; antigen test ; antigen based test ; antibody detection ; antibody based detection ; detect antibodies ; antigen detection ; antigen based detection ; detect antigen ; detection test ; detection tests ; detection limit ; SARS-CoV-2 infection ; COVID-19 infection ; COVID19 infection ; SARS-CoV2 infection ; Severe acute respiratory syndrome coronavirus 2 infection ; coronavirus disease 2019 infection ; 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 ;