Document text
Principal Investigator: George B Sigal
Organization: MESO SCALE DIAGNOSTICS, LLC
Fiscal Year: 2024
Award: $837,128
Funding agency: National Institute of Allergy and Infectious Diseases
Our objective is to develop better assays for measuring antibodies produced in people after influenza infection
or vaccination. We’ll develop assays that measure total antibody responses, and assays that specifically
measure the antibodies responsible for protection from infection. By using high-throughput multiplexed formats
employing reagents that can be prepared and stored in large lots, the assays will address many of the practical
limitations of current gold standard methods like the hemagglutination inhibition assay (HAI) and the viral micro-
neutralization (MN) assay. The assays will use the Meso Scale Diagnostics® (MSD) electrochemiluminescence
(ECL) assay platform, which has been widely adopted for qualification of COVID-19, pneumococcal and other
vaccines. The assays will use multi-well plates with arrays of influenza hemagglutinin (HA) in each well to
support the simultaneous measurement of antibodies against the strains represented in a vaccine, and to
analyze cross-protection against other strains of interest. A set of detection reagents and assay formats will be
developed that, when used with the antigen array component, will support a range of measurement modalities.
These include the measurement of (i) antibodies that block the ability of each antigen to recognize sialic acid
(SA) modified host proteins; (ii) total IgG and/or IgA against each antigen (in blood or respiratory samples); and
(iii) antibodies recognizing pre-selected universal epitopes. Through this work, we will provide important tools for
accelerating the development of new influenza vaccines.
The phased UH2/UH3 program will include the following main components. In the UH2 feasibility/early
development phase we will develop and optimize the required assay reagents needed to measure antibody
responses to 10 recent vaccine strains, as well as several historical human strains and potentially pandemic
avian strains. In this phase, we will also optimize the assay formats and assemble sample sets for later validation
work. In the UH3 validation phase, we will establish manufacturing procedures for producing assay kits to
conduct the proposed assay methods, and validate performance by testing well-characterized sample sets and
comparing our results to established gold standard methods.
†The sections on documents contained in this proposal that are marked with an asterisk contain proprietary/confidential information that MSD requests not be released to
persons outside the Government, except for purposes of review and evaluation.
Terms: <2019-nCoV vaccine><7S Gamma Globulin><Acceleration><Ad vector><Address><Adenoviral Vector><Adenovirus Vector><Adopted><Airway infections><Animals><Antibodies><Antibody Diversity><Antibody Response><Antigenic Determinants><Antigens><Assay><Assessment instrument><Assessment tool><Aves><Avian><Benchmarking><Best Practice Analysis><Binding Determinants><Bioassay><Biological><Biological Assay><Birds><Blocking Antibodies><Blood><Blood Reticuloendothelial System><Blood erythrocyte><COVID-19><COVID-19 vaccine><CV-19><Clinical><Clinical Research><Clinical Study><Community Developments><Confidential Information><Coronavirus Infectious Disease 2019><Cultured Cells><D pneumoniae><D. pneumoniae><Detection><Development><Development and Research><Diagnostic><Diplococcus pneumoniae><Epitopes><Erythrocytes><Erythrocytic><Evaluation><Flu vaccination><Genetic Alteration><Genetic Change><Genetic defect><Government><Grippe><Hemagglutination><Hemagglutinin><Human><IgA><IgG><Immune><Immune Evasion><Immune system><Immunes><Immunoglobulin A><Immunoglobulin G><Immunology><Immunology procedure><Infection><Influenza><Influenza HA><Influenza Hemagglutinin><Influenza Vaccines><Influenza immunization><Influenza vaccination><Label><Marrow erythrocyte><Measurement><Measures><Messenger RNA><Methods><Michigan><Modality><Modern Man><Mutation><N-Acetylneuraminic Acids><Pathway interactions><Persons><Phase><Pneumococcus><Preparation><Procedures><Process><Prophylactic vaccination against influenza><Proteins><Protocol><Protocols documentation><Qualifying><Quality Control><R & D><R&D><Reagent><Recombinants><Red Blood Cells><Red Cell><Respiratory Infections><Respiratory Tract Infections><Running><S pneumoniae><S. pneumoniae><SARS-CoV-2 vaccine><SARS-coronavirus-2 vaccine><Sampling><Serology test><Severe Acute Respiratory Syndrome CoV 2 vaccine><Severe acute respiratory syndrome coronavirus 2 vaccine><Sialic Acids><Site><Streptococcus pneumoniae><Translational Research><Translational Science><Update><Vaccination><Vaccines><Validation><Viral><Viral Diseases><Virus Diseases><Work><adeno vector><adenovector><antibody assay><antibody based test><antibody test><assay development><benchmark><biologic><blood corpuscles><commercialization><coronavirus disease 2019><coronavirus disease 2019 vaccine><coronavirus disease-19><coronavirus disease-19 vaccine><coronavirus infectious disease-19><cross immunity><cross protection><develop a vaccine><develop vaccines><development of a vaccine><developmental><flexibility><flexible><flu><flu HA><flu hemagglutinin><flu immunisation><flu infection><flu vaccine><flu virus infection><flu virus vaccine><genome mutation><immune evasive><immunogen><immunogenicity><immunologic assay><immunologic assay/test><improved><infected with flu><infected with flu virus><infected with influenza><infected with influenza virus><influenza infection><influenza viral HA><influenza viral hemagglutinin><influenza virus HA><influenza virus hemagglutinin><influenza virus infection><influenza virus vaccination><influenza virus vaccine><innovate><innovation><innovative><interest><mRNA><manufacture><nCoV vaccine><nCoV-19 vaccine><nCoV19 vaccine><nano particle><nano-sized particle><nanoparticle><nanosized particle><new vaccines><next generation><next generation vaccines><novel vaccines><pandemic concern><pandemic potential><pandemic risk><pandemic threat><pathway><performance tests><preparations><product development><programs><research and development><respiratory><serology assay><sialic acid-binding hemagglutinin><sialic acid-binding lectin><success><technology platform><technology system><time use><tool><translation research><translational investigation><vaccination against influenza><vaccination study><vaccination trial><vaccine against 2019-nCov><vaccine against COVID-19><vaccine against SARS-CoV-2><vaccine against SARS-coronavirus-2><vaccine against Severe Acute Respiratory Syndrome CoV 2><vaccine against Severe acute respiratory syndrome coronavirus 2><vaccine against flu><vaccine against influenza><vaccine candidates against SARS-CoV-2><vaccine development><vaccine effectiveness><vaccine for novel coronavirus><vaccine study><vaccine trial><vaccines preventing COVID><vaccines to prevent COVID><validations><viral infection><virus infection><virus-induced disease>