Grant List
Represents Grant table in the DB
GET /v1/grants?page%5Bnumber%5D=1383&sort=-title
{ "links": { "first": "https://cic-apps.datascience.columbia.edu/v1/grants?page%5Bnumber%5D=1&sort=-title", "last": "https://cic-apps.datascience.columbia.edu/v1/grants?page%5Bnumber%5D=1419&sort=-title", "next": "https://cic-apps.datascience.columbia.edu/v1/grants?page%5Bnumber%5D=1384&sort=-title", "prev": "https://cic-apps.datascience.columbia.edu/v1/grants?page%5Bnumber%5D=1382&sort=-title" }, "data": [ { "type": "Grant", "id": "10820", "attributes": { "award_id": "1R43AI174383-01", "title": "A Novel Multi-Epitope-Based Universal Vaccine Against Multiple Coronavirus Variants of Concern", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Institute of Allergy and Infectious Diseases (NIAID)" ], "program_reference_codes": [], "program_officials": [ { "id": 6908, "first_name": "JENNIFER L.", "last_name": "Gordon", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2023-02-01", "end_date": "2025-01-31", "award_amount": 300000, "principal_investigator": { "id": 26904, "first_name": "Hawa", "last_name": "Vahed", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [], "awardee_organization": { "id": 1968, "ror": "", "name": "TECHIMMUNE, LLC", "address": "", "city": "", "state": "CA", "zip": "", "country": "United States", "approved": true }, "abstract": "Over the last 2 years humanity has been confronting COVID-19 pandemic caused by the new Corona Virus 2 (SARS-CoV-2) infection. Major gaps: Mutations and deletions often occur in the genome of SARS-CoV-2 (predominantly in the Spike protein) resulting in more transmissible and pathogenic “variants of concern” (VOCs) that can escape immunity conferred by first generation COVID-19 vaccines. Because most mutations and deletions that produced the 20 known VOCs are concentrated on the Spike protein, there is a risk that current COVID-19 sub-unit vaccines based on the Spike protein will fail to protect against future VOCs despite inducing strong virus-specific neutralizing antibodies against the original virus strain. Among the 80 mutations/deletions present in OMICRON variant, 32 mutations/deletions are concentrated in the sequence Spike protein alone. This emphasizes two major limitations of currently available vaccines: The need for second-generation universal coronavirus vaccines that (1) target antigens (Ags) other than the highly variable Spike protein; and (2) incorporate both B- and T-cell epitopes from Spike and non-Spike Ags that are highly conserved in all 20 VOCs and that will induce strong humoral and cell-mediated immune responses. Our long-term goal is to develop a potent second generation universal CoV vaccine to stop/reduce SARS-CoV-2 infections and disease caused by multiple VOCs. Preliminary Results: We: (1) Identified highly immunogenic human B and T cell target epitopes from the whole SARS-CoV-2 genome; (2) Characterized human T cell epitopes from the whole SARS-CoV-2 genome that are selectively targeted by the “protective” immune system from asymptomatic COVID-19 patients; and (3) Produced a first prototype multi-epitope universal CoV vaccine candidate using the validated mRNA delivery system platform, and (4) Created novel “humanized” susceptible HLA-DR/HLA-A*0201/hACE2 triple transgenic mouse model with which to test 7 additional multi-epitope universal CoV vaccine candidates that bear different highly conserved human B and T cell epitopes spanning the entire CoV genome. We hypothesize that one or more of our 7 universal vaccine candidates will protect “humanized” mice from infection and disease caused by intranasal inoculation with SARS-CoV-2 a, b, g, d and Omicron VOCs. Our Specific Aims are: Aim 1: To design and construct 7 additional mRNA-based universal vaccine candidates that will incorporate highly conserved B and T cell epitopes selected from 20 VOCs. Aim 2: To determine the safety, immunogenicity, and protective efficacy against SARS-CoV-2 a, b, g, d or Omicron VOCs of 7 multi-epitope universal CoV vaccine candidates delivered intranasally in the “humanized” HLA-DR/HLA-A*0201/hACE2 mouse model. The durability of protection and its correlation with blocking/neutralizing antibodies and the number and function of CoV-specific CD4+ and CD8+ TRM cells that reside in the lungs and brains will be determined. If successful, the lead universal CoV vaccine that protects against most of the 5 VOCs could proceed quickly into an FDA Phase 1 clinical trial", "keywords": [ "2019-nCoV", "Affect", "Amino Acid Sequence", "Antigen Targeting", "Antigens", "Authorization documentation", "B-Lymphocytes", "Brain", "CD8B1 gene", "COVID-19", "COVID-19 outbreak", "COVID-19 pandemic", "COVID-19 patient", "COVID-19 vaccine", "Cells", "Cessation of life", "China", "Coronavirus", "Country", "DNA Sequence Alteration", "Disease", "Disease Outbreaks", "Epitopes", "Future", "Generations", "Genome", "Goals", "HLA A*0201 antigen", "HLA-DR Antigens", "Human", "Humanities", "Immune system", "Immunity", "Infection", "Lead", "Lung", "Messenger RNA", "Mutate", "Mutation", "Outcome", "Pathogenicity", "Phase I Clinical Trials", "Preclinical Testing", "Predisposition", "Proteins", "Province", "Reporting", "Risk", "SARS-CoV-2 genome", "SARS-CoV-2 infection", "SARS-CoV-2 variant", "Safety", "Seasons", "South Africa", "Speed", "Subunit Vaccines", "System", "T-Lymphocyte", "T-Lymphocyte Epitopes", "Testing", "Transgenic Mice", "Ursidae Family", "Vaccines", "Validation", "Variant", "Viral Antigens", "Virus", "asymptomatic COVID-19", "authority", "base", "cell mediated immune response", "coronavirus disease", "design", "design and construction", "humanized mouse", "immunogenic", "immunogenicity", "innovation", "mRNA delivery", "mouse model", "neutralizing antibody", "novel", "novel coronavirus", "pandemic disease", "pre-clinical", "protective efficacy", "prototype", "public health emergency", "universal coronavirus vaccine", "universal vaccine", "vaccine access", "vaccine candidate", "vaccine platform", "variants of concern" ], "approved": true } }, { "type": "Grant", "id": "7082", "attributes": { "award_id": "3R01AI145147-02S1", "title": "A novel mouse model for SARS-CoV-2 infection and therapeutics screening", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Institute of Allergy and Infectious Diseases (NIAID)" ], "program_reference_codes": [], "program_officials": [ { "id": 7389, "first_name": "Halonna R.", "last_name": "Kelly", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2020-06-02", "end_date": "2021-11-30", "award_amount": 525989, "principal_investigator": { "id": 22876, "first_name": "STEPHEN C", "last_name": "JAMESON", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [ { "id": 764, "ror": "https://ror.org/017zqws13", "name": "University of Minnesota", "address": "", "city": "", "state": "MN", "zip": "", "country": "United States", "approved": true } ] }, "other_investigators": [], "awardee_organization": { "id": 764, "ror": "https://ror.org/017zqws13", "name": "University of Minnesota", "address": "", "city": "", "state": "MN", "zip": "", "country": "United States", "approved": true }, "abstract": "Animal models of COVID-19 will play a critical role in developing and testing novel vaccines and therapies for this disease, but a very limited number of models are currently available, and they suffer from substantial limitations. The SARS-CoV-2 virus uses human ACE2 to bind to cells, and the host TMPRSS2 protease to prime the viral spike proteins for entry. Three mouse strains expressing human ACE2 as a transgene exist— only one of which is being prepared for distribution in the US and is in high demand under the current circumstance. Furthermore, concerns exist about aberrant expression of human ACE2 in these mice, given the lack of normal regulatory elements, and none of the ACE2 transgenic strains express the human TMPRSS2 protease, thus cannot be used to assess therapeutic strategies that target the protease. We propose to employ a novel and rapid gene replacement strategy that we have pioneered, to generate ACE2 and TMPRSS2 gene replacement mice. Our BSL3 experienced team will infect these mice with SARS-CoV-2 in order to determine if they display the expected viral replication, interstitial pneumonia, inflammatory cytokine storm, and antibody responses that characterize human COVID-19 disease. Importantly, these mice will be immediately sent to our partners at Jackson Labs (JAX) for rapid expansion and world-wide distribution.", "keywords": [ "2019-nCoV", "Alternative Splicing", "Alzheimer&apos", "s Disease", "Animal Model", "Animals", "Antibodies", "Antibody Response", "Binding", "Blood", "Body Weight decreased", "Brain", "COVID-19", "Cells", "China", "Cloning", "Complementary DNA", "Deposition", "Development", "Disease", "ES Cell Line", "Elements", "Engineering", "Ensure", "Enzyme-Linked Immunosorbent Assay", "Gene Expression", "Genes", "Growth", "Human", "Human Characteristics", "Human Genome", "Immune", "Immune response", "Immunoglobulin G", "Immunoglobulin M", "Infection", "Inflammatory", "Intention", "Interleukin-6", "Interstitial Pneumonia", "Lung", "Methods", "Modality", "Modeling", "Mouse Strains", "Mus", "Pathogenesis", "Pathogenicity", "Pathology", "Pattern", "Peptide Hydrolases", "Play", "Procedures", "Process", "Protease Inhibitor", "Proteins", "Pulmonary Pathology", "Regulatory Element", "Reporting", "Research", "Research Personnel", "Role", "SARS coronavirus", "Severe Acute Respiratory Syndrome", "Site", "Spleen", "Spliced Genes", "Synteny", "System", "TMPRSS2 gene", "TNF gene", "Testing", "Therapeutic", "Time", "Tissues", "Transgenes", "Transgenic Organisms", "Uncertainty", "Vaccination", "Viral", "Viral Load result", "Virus", "Virus Diseases", "Virus Replication", "Work", "adaptive immune response", "base", "cytokine", "cytokine release syndrome", "embryonic stem cell", "experience", "experimental study", "gene replacement", "genomic locus", "human tissue", "humanized mouse", "improved", "infectious disease model", "mouse model", "novel", "novel therapeutics", "novel vaccines", "pathogen", "promoter", "receptor", "receptor binding", "recombinase", "respiratory", "screening", "transgene expression" ], "approved": true } }, { "type": "Grant", "id": "8194", "attributes": { "award_id": "1R43HL158344-01", "title": "A novel monoclonal antibody-based anti-NK cell anti-inflammatory strategy for treating autoimmune and checkpoint inhibitor induced myocarditis", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Heart Lung and Blood Institute (NHLBI)" ], "program_reference_codes": [], "program_officials": [ { "id": 22519, "first_name": "YANG", "last_name": "Shi", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2021-04-15", "end_date": "2022-04-14", "award_amount": 308650, "principal_investigator": { "id": 24035, "first_name": "Dror", "last_name": "Luger", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [ { "id": 1687, "ror": "", "name": "INFLAMMA THERAPEUTICS, LLC", "address": "", "city": "", "state": "CA", "zip": "", "country": "United States", "approved": true } ] }, "other_investigators": [], "awardee_organization": { "id": 1687, "ror": "", "name": "INFLAMMA THERAPEUTICS, LLC", "address": "", "city": "", "state": "CA", "zip": "", "country": "United States", "approved": true }, "abstract": "The Problem: Despite current therapies, the prognosis of various forms of acute and chronic inflammation of the heart (myocarditis) remains poor. Immune reactions that attack a patient’s own tissues (autoimmune disease) is one major cause of myocarditis. Additionally, one of the complications of immune checkpoint inhibitors (ICI), which attack cancer cells though activation of inflammation, is myocarditis. Innovation: Inflammation involves multiple molecules and multiple redundant pathways. The anti-inflammatory monoclonal antibodies (mAbs) forming the basis of treatment of inflammation-related diseases target a single molecule and a single inflammatory pathway. Therapeutic efficacy is thereby limited. NK cells are major orchestrators of multiple inflammatory pathways. Inflamma Therapeutics (IFT) therefore developed a novel mAb—IFT100—that depletes NK cells. By inhibiting NK cells IFT100 inhibits multiple inflammatory pathways. As proof-of-concept of the efficacy of an NK cell depleting strategy, we demonstrated that an anti-NK cell mAb that depletes mouse NK cells improves myocardial function in mice with acute heart attacks or with chronic heart failure. IFT therefore decided to develop an anti-human NK cell mAb—IFT100—to serve as an immunosuppressive therapeutic agent to treat inflammation-exacerbated human disease. IFT found that IFT 101 binds to and depletes human NK cells. IFT100 was sequenced and patents submitted. The AIMS of the current proposal, using IFT100: Aim 1: Determine the dose response for in-vivo NK cell depletion in mice. Aim 2: Determine the impact of NK cell depletion on the prevention of Experimental Autoimmune Myocarditis. Aim 3: Determine the impact of NK cell depletion on the prevention of Experimental Autoimmune Myocarditis with or without the burden of ICI treatment. Aim 4: Humanize our mAb. In this project we will be validating the ability of our specific mAb (IFT100) to improve autoimmune-induced and ICI-induced myocarditis. Importantly, however, we believe IFT100 will also be effective for improving outcomes in many other diseases that are worsened by excessive inflammation. These include myocardial dysfunction in patients with chronic heart failure, with cardiogenic shock, and with acute MI. Another important additional therapeutic target for IFT100 is the massive inflammatory response responsible for most of the deaths seen in Covid-19. Each of these conditions has no current effective therapy and, as such, constitute conditions for which there are major unmet therapeutic needs.", "keywords": [ "Acute", "Acute Myocarditis", "Acute myocardial infarction", "Address", "Anti-Inflammatory Agents", "Autoimmune", "Autoimmune Diseases", "Autoimmune Process", "Binding", "COVID-19", "COVID-19 mortality", "Cancer Patient", "Cardiogenic Shock", "Cells", "Cessation of life", "Chimera organism", "Chronic", "Clinical Trials", "Complex", "Complication", "Congestive Heart Failure", "Data", "Disease", "Dose", "Echocardiography", "Etiology", "Flow Cytometry", "Heart", "Histology", "Human", "IgG1", "Immune", "Immune checkpoint inhibitor", "Immune response", "Immune system", "Immunization", "Immunoglobulin Variable Region", "In Vitro", "Incidence", "Infiltration", "Inflammation", "Inflammatory", "Inflammatory Response", "Interleukin-1", "Interleukin-6", "Intravenous", "Knowledge", "Legal patent", "Measures", "Monoclonal Antibodies", "Monoclonal Antibody Therapy", "Mus", "Myocardial", "Myocardial Infarction", "Myocardial dysfunction", "Myocarditis", "Natural Killer Cells", "Pathway interactions", "Patients", "Pharmaceutical Preparations", "Phase", "Prevention", "Prognosis", "Rheumatoid Arthritis", "Severities", "Steroids", "TNF gene", "Therapeutic", "Therapeutic Agents", "Therapeutic immunosuppression", "Tissues", "Treatment Efficacy", "Virus", "Virus Diseases", "autoimmunity checkpoint", "base", "cancer cell", "checkpoint therapy", "chronic myocarditis", "cytokine release syndrome", "effective therapy", "human disease", "immunoreaction", "improved", "improved outcome", "in vivo", "inhibiting antibody", "innovation", "mortality", "novel", "pre-clinical", "preclinical study", "response", "side effect", "single molecule", "success", "therapeutic target", "validation studies" ], "approved": true } }, { "type": "Grant", "id": "5052", "attributes": { "award_id": "5R21AI164449-02", "title": "A novel model to study COVID-19 and Hypertension", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Institute of Allergy and Infectious Diseases (NIAID)" ], "program_reference_codes": [], "program_officials": [ { "id": 18074, "first_name": "Erik J.", "last_name": "Stemmy", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2021-06-14", "end_date": "2023-05-31", "award_amount": 193125, "principal_investigator": { "id": 18075, "first_name": "BINA", "last_name": "JOE", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [], "awardee_organization": { "id": 823, "ror": "", "name": "UNIVERSITY OF TOLEDO HEALTH SCI CAMPUS", "address": "", "city": "", "state": "OH", "zip": "", "country": "United States", "approved": true }, "abstract": "7. Project Summary/Abstract Animal models fare indispensable for understanding the pathology of COVID-19 as well as for developing vaccines. They are also important to discern the etiology of COVID-19 in specific groups at risk, such as individuals with pre-existing hypertension. While there are hamsters, ferrets, cats, nonhuman primates and K18- hACE2 transgenic mice as possible models for studying COVID-19, none serves the purpose of studying the relationship between hypertension and susceptibility to COVID-19 because (1) wild-type research models do not get infected with the human SARS-CoV-2 and/or (2) they are not genetically prone to hypertension. To fill this unmet need, we propose to develop in vivo experimental platform for studying COVID-19 in the setting of hypertension. In preliminary data, we present evidence for the development of a novel knock-in rat model of the hypertensive Dahl Salt-sensitive (S) rat edited using the CRISPR/Cas9 technology to express the human ACE2 gene (hACE2), which is the receptor for SARS-CoV-2. The gene hACE2 is inserted to replace the rat Ace2 locus. The required rat Ace2 knockout as the control strain (rAce2-KO) has also been generated. By comparing these 2 strains, in Aim 1 we will examine the suitability of this rat model for studying COVID-19. Further, based on our recent published work using germ-free rats indicating that introduction of microbiota to germ-free rats upregulated colonic Ace2 expression and blood pressure combined with the existing knowledge of a strong relationship between salt-sensitive hypertension and the gut microbiota; in Aim 2, we will test the hypothesis that the loss of normal symbiosis between the host and gut microbiota during a hypertensive state is responsible for the lower ACE2 expression in multiple organs.", "keywords": [ "2019-nCoV", "ACE2", "Address", "Animal Model", "Animals", "Antihypertensive Agents", "Blood Pressure", "COVID-19", "COVID-19 pandemic", "COVID-19 pathogenesis", "COVID-19 severity", "COVID-19 therapeutics", "COVID-19 vaccine", "COVID-19 vaccine evaluation", "CRISPR/Cas technology", "Communities", "Contracts", "Dahl Hypertensive Rats", "Data", "Development", "Diet", "Dietary Sodium", "Etiology", "Experimental Models", "Felis catus", "Ferrets", "Gene Expression", "Genes", "Germ-Free", "Hamsters", "Hand", "Human", "Hypertension", "Individual", "Intake", "K-18 conjugate", "Knock-in", "Knock-out", "Knowledge", "Light", "Medical", "Modeling", "Mus", "Names", "Organ", "Pathogenesis", "Pathology", "Patients", "Play", "Predisposition", "Publishing", "Rattus", "Reporting", "Research", "Risk", "Role", "SARS-CoV-2 infection", "SARS-CoV-2 transmission", "Sodium Chloride", "Sodium-Restricted Diet", "Study models", "Symbiosis", "Testing", "Therapeutic", "Time", "Transgenic Mice", "Virus", "Virus Shedding", "Work", "animal data", "base", "design", "dietary salt", "dysbiosis", "effectiveness evaluation", "fecal transplantation", "gut microbiota", "high risk", "high salt diet", "host microbiota", "hypertensive", "hypertensives", "in vivo", "interest", "microbial", "microbiota", "nonhuman primate", "novel", "novel coronavirus", "protein expression", "receptor", "salt sensitive", "salt sensitive hypertension", "sex", "vaccine development" ], "approved": true } }, { "type": "Grant", "id": "5786", "attributes": { "award_id": "1R21AI164449-01", "title": "A novel model to study COVID-19 and Hypertension", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Institute of Allergy and Infectious Diseases (NIAID)" ], "program_reference_codes": [], "program_officials": [ { "id": 19899, "first_name": "Erik J.", "last_name": "Stemmy", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2021-06-14", "end_date": "2023-05-31", "award_amount": 231750, "principal_investigator": { "id": 19900, "first_name": "BINA", "last_name": "JOE", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [], "awardee_organization": { "id": 823, "ror": "", "name": "UNIVERSITY OF TOLEDO HEALTH SCI CAMPUS", "address": "", "city": "", "state": "OH", "zip": "", "country": "United States", "approved": true }, "abstract": "7. Project Summary/Abstract Animal models fare indispensable for understanding the pathology of COVID-19 as well as for developing vaccines. They are also important to discern the etiology of COVID-19 in specific groups at risk, such as individuals with pre-existing hypertension. While there are hamsters, ferrets, cats, nonhuman primates and K18- hACE2 transgenic mice as possible models for studying COVID-19, none serves the purpose of studying the relationship between hypertension and susceptibility to COVID-19 because (1) wild-type research models do not get infected with the human SARS-CoV-2 and/or (2) they are not genetically prone to hypertension. To fill this unmet need, we propose to develop in vivo experimental platform for studying COVID-19 in the setting of hypertension. In preliminary data, we present evidence for the development of a novel knock-in rat model of the hypertensive Dahl Salt-sensitive (S) rat edited using the CRISPR/Cas9 technology to express the human ACE2 gene (hACE2), which is the receptor for SARS-CoV-2. The gene hACE2 is inserted to replace the rat Ace2 locus. The required rat Ace2 knockout as the control strain (rAce2-KO) has also been generated. By comparing these 2 strains, in Aim 1 we will examine the suitability of this rat model for studying COVID-19. Further, based on our recent published work using germ-free rats indicating that introduction of microbiota to germ-free rats upregulated colonic Ace2 expression and blood pressure combined with the existing knowledge of a strong relationship between salt-sensitive hypertension and the gut microbiota; in Aim 2, we will test the hypothesis that the loss of normal symbiosis between the host and gut microbiota during a hypertensive state is responsible for the lower ACE2 expression in multiple organs.", "keywords": [ "2019-nCoV", "ACE2", "Address", "Animal Model", "Animals", "Antihypertensive Agents", "Blood Pressure", "COVID-19", "COVID-19 pandemic", "COVID-19 pathogenesis", "COVID-19 severity", "COVID-19 therapeutics", "COVID-19 vaccine", "COVID-19 vaccine evaluation", "CRISPR/Cas technology", "Communities", "Contracts", "Dahl Hypertensive Rats", "Data", "Development", "Diet", "Dietary Sodium", "Etiology", "Experimental Models", "Felis catus", "Ferrets", "Gene Expression", "Genes", "Germ-Free", "Hamsters", "Hand", "Human", "Hypertension", "Individual", "Intake", "K-18 conjugate", "Knock-in", "Knock-out", "Knowledge", "Light", "Medical", "Modeling", "Mus", "Names", "Organ", "Pathogenesis", "Pathology", "Patients", "Play", "Predisposition", "Publishing", "Rattus", "Reporting", "Research", "Risk", "Role", "SARS-CoV-2 infection", "SARS-CoV-2 transmission", "Sodium Chloride", "Sodium-Restricted Diet", "Study models", "Symbiosis", "Testing", "Therapeutic", "Time", "Transgenic Mice", "Vaccines", "Virus", "Virus Shedding", "Work", "animal data", "base", "design", "dietary salt", "dysbiosis", "effectiveness evaluation", "fecal transplantation", "gut microbiota", "high risk", "high salt diet", "host microbiota", "in vivo", "interest", "microbial", "microbiota", "nonhuman primate", "novel", "novel coronavirus", "protein expression", "receptor", "salt sensitive", "salt sensitive hypertension", "sex" ], "approved": true } }, { "type": "Grant", "id": "15376", "attributes": { "award_id": "1R43HL172484-01", "title": "A novel mobile phone technology to improve access for preeclampsia and hypertension detection", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Heart Lung and Blood Institute (NHLBI)" ], "program_reference_codes": [], "program_officials": [ { "id": 25676, "first_name": "JASMINA", "last_name": "Varagic", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2024-09-20", "end_date": "2025-08-31", "award_amount": 292897, "principal_investigator": { "id": 31977, "first_name": "John conrad", "last_name": "Heironimus", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [ { "id": 28353, "first_name": "Martin Richard", "last_name": "Huecker", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, { "id": 28354, "first_name": "David", "last_name": "Wolfson", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "awardee_organization": { "id": 2096, "ror": "", "name": "TELE-STETHOSCOPE INC.", "address": "", "city": "", "state": "KY", "zip": "", "country": "United States", "approved": true }, "abstract": "/ Abstract Preeclampsia is a complication affecting 2 – 8% of all pregnancies and results in significant maternal and neonatal morbidity and mortality. The invention to be researched in this grant detects preeclampsia and hypertension in patients with the phones that they already own. It improves outcomes by increasing access to care among underserved populations and monitoring frequency among high risk patients. Patients record themselves using their own phones which takes only a few minutes. The long term objective is to commercialize a product which enables any of 7 billion phones to assist in preeclampsia or gestational hypertension detection. The invention is intended to be used at home by patients via a phone app with results sent to the prescribing obstetrician (OB). The purpose is to alert the OB if immediate physical examination is needed and to initiate possible preeclampsia management protocol. In these situations, there are no other comparable testing options. The invention includes both improvements to clinical practice and to science. Current clinical practice standard of care requires patients to be examined in an OB office. The invention allows preeclampsia and hypertension to be detected via patient self-examination from locations outside the OB office. This improves upon current technology such as home blood pressure cuffs and in-office dipstick urinalysis. In terms of improvements to science, the invention consists of both a Universal Translator (UT) and Deductive Intelligence (DI). UT allows for any mobile phone to capture body acoustic data. DI is a novel physics based approach to creating classifier algorithms from passively received time series data, such as mobile phone recordings received from the UT. The invention analyzes hemodynamics and extracts pertinent physics based features from which a classifier algorithm is based. This will be the third large scale human study that demonstrates classification of cardio - pulmonary functionality. It follows a published study on COVID detection as well as a study under peer review on the ability to reproduce echocardiogram estimates of ejection fraction. The echocardiogram study establishes the protocol to be used in the proposed research. In a recent preliminary study, 46 pregnant women were recorded at the aortic site. The resulting model was able to determine which patients had high blood pressure and to accurately determine which patients had complications. These studies support our hypothesis that acoustic hemodynamic data captured by OEM phone microphones, at the aortic auscultation site and at the upper arm, can be used to identify patients who have preeclampsia and/or hypertension. The study has two primary aims. The first is to demonstrate proof of concept that the invention enables ordinary mobile phones to reproduce physicians’ diagnosis of pre-eclampsia. The second aim is to demonstrate proof of concept that the invention enables ordinary mobile phones to reproduce cuff measurements of blood pressure and to detect hypertension. The approach is based on recruitment from both outpatient clinics and inpatient hospital settings. Patients already labeled with preeclampsia or high blood pressure will be enrolled as well as control patients without disease conditions. Patients will be recorded by clinicians with a custom phone app. Algorithms will be developed based on these recordings using UT and DI. Results will be tested and analyzed using AUC, sensitivity/specificity, accuracy as well adj RSQ for the linear regression analysis. The team consists of a broad range of talent including the inventor of the technology, the Maternal Fetal Medicine Division Director at the hospital, the research director of emergency medicine for the hospital running the tests, statistical expertise, and project management.", "keywords": [], "approved": true } }, { "type": "Grant", "id": "14855", "attributes": { "award_id": "1R21AI180713-01A1", "title": "A Novel Janus Bead Blood Assay for Point-of-Care Assessment of HCV Viral Load and Associated Liver Damage", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Institute of Allergy and Infectious Diseases (NIAID)" ], "program_reference_codes": [], "program_officials": [ { "id": 27983, "first_name": "JULIE", "last_name": "Dyall", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2024-07-08", "end_date": "2026-05-31", "award_amount": 211275, "principal_investigator": { "id": 31540, "first_name": "Hsueh-Chia", "last_name": "Chang", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [], "awardee_organization": { "id": 171, "ror": "https://ror.org/00mkhxb43", "name": "University of Notre Dame", "address": "", "city": "", "state": "IN", "zip": "", "country": "United States", "approved": true }, "abstract": "Globally, nearly 300,000 people die from hepatitis C virus (HCV) related liver diseases, most of them in developing nations with poor resources. Until the recent COVID pandemic, hepatitis C virus is also one of the leading cause of death in the US by infection. WHO aims to eliminate HCV deaths by 2030. This ambitious goal can only be achieved if HCV infected patients with severe liver disease, including liver cancer, can be diagnosed and treated rapidly. The current gold standard, for HCV diagnostics for both developing and developed countries, is a point-of-care (POC) host antibody test, based on saliva sample or finger prick blood sample, followed by a lab-bound reverse-transcription PCR estimate of the viral RNA (load). The first test does not indicate active infection that should be treated. This is determined by the second viral load test, which also determines the severity of the infection and the selection of proper treatment or more invasive diagnosis. The key obstacle to successfully diagnosing and treating HCV infected patients with liver diseases in the developing world is the second PCR test for viral load. There are very few laboratories for such tests and mail delivery of blood samples is not feasible in a country with low resource. Many patients that tested positive by the POC antibody test do not or cannot travel to the laboratories for the PCR and antigen tests. This proposal aims to integrate two technologies with a smart-phone imaging device to provide a 30-minute one- step POC assay with untreated blood that can quantify viral load and determine the specific liver disease. It is based on a Janus microparticle assay that has the sensitivity of the PCR test but requires much less personnel attention and is much more rapid. Its rapidity (30 minutes) is partly because sample prep is unnecessary. As its signal can only be provided by the virus, rather than its RNA (or protein), only a rapid ultrafiltration step is required to enrich the virus. The PIs have developed such an ultrafiltration technology for extracellular vesicles (EVs). Since the HCV virus is the same size as the EVs, this ultrafiltration technology will be developed for virus and integrated with the Janus particle assay to provide a one-step POC viral load quantification platform. The direct virus assay reduces the sample volume so that capillary drawn blood sample is adequate. The only instrumentation needed for the POC platform is a portable smart-phone based imaging system. Upon completion of this R21 project, a business partner Aopia will design integrated prototypes that can process multiple samples for a major clinical trial after the funding period.", "keywords": [], "approved": true } }, { "type": "Grant", "id": "8636", "attributes": { "award_id": "3R21AA027180-02S2", "title": "A Novel Human Laboratory Model for Screening Medications for Alcohol Use Disorder", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Institute on Alcohol Abuse and Alcoholism (NIAAA)" ], "program_reference_codes": [], "program_officials": [ { "id": 23473, "first_name": "Daniel Evan", "last_name": "Falk", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2021-08-10", "end_date": "2022-08-31", "award_amount": 46800, "principal_investigator": { "id": 24052, "first_name": "LARA A.", "last_name": "RAY", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [ { "id": 818, "ror": "", "name": "UNIVERSITY OF CALIFORNIA LOS ANGELES", "address": "", "city": "", "state": "CA", "zip": "", "country": "United States", "approved": true } ] }, "other_investigators": [], "awardee_organization": { "id": 818, "ror": "", "name": "UNIVERSITY OF CALIFORNIA LOS ANGELES", "address": "", "city": "", "state": "CA", "zip": "", "country": "United States", "approved": true }, "abstract": "This administrative supplement application is intended to support the timely and full completion of the proposed study and to offset delays caused by the COVID-19 Pandemic. As detailed in the application, we have dealt with a host of COVID-19 related delays, while also maintaining the laboratory open and conducting ongoing recruitment to the maximum degree allowed by the UCLA COVID-19 Response and Recovery Task Force. In this administrative supplement, we carefully justify the request for additional resources to effectively complete the original project and mitigate COVID-19 delays in recruitment. Despite the challenges of the COVID-19 pandemic our team has been resilient and hard-working. We have maintained recruitment efforts to the best of our ability and completed 19 randomizations during a full year of COVID-19 disruption. Further, we have kept the protocol integrity and have conducted daily telephone and zoom-based sessions, which enable close contact between participants and study staff. This allowed us to stay consistent with regard to the proposed protocol, provide careful medication management, verify medication compliance, and obtain all necessary clinical safety labs at the beginning of study participation. This administrative supplement will provide much-needed support a high-fidelity protocol that has been kept intact and operational despite substantial challenges associated with the pandemic.", "keywords": [ "Administrative Supplement", "Advisory Committees", "Alcohol consumption", "Alcohols", "Area", "COVID-19", "COVID-19 pandemic", "Clinical", "Clinical Research", "Clinical Trials", "Cross-Over Studies", "Crossover Design", "Cues", "DSM-V", "Detection", "Development", "Disease", "Double-Blind Method", "FDA approved", "Human", "Individual", "Laboratories", "Laboratory Study", "Literature", "Medication Management", "Methods", "Modeling", "Naltrexone", "Outcome", "Participant", "Persons", "Pharmaceutical Preparations", "Pharmacotherapy", "Phase", "Placebos", "Procedures", "Process", "Protocols documentation", "Randomized", "Reading", "Recovery", "Reporting", "Research Priority", "Resources", "Safety", "Self Administration", "Signal Transduction", "Telephone", "Testing", "Time", "Translations", "Treatment Efficacy", "United States", "Woman", "alcohol craving", "alcohol cue", "alcohol response", "alcohol screening", "alcohol use disorder", "base", "breath alcohol measurement", "clinically relevant", "cost", "cue reactivity", "drinking", "drinking behavior", "improved", "intrinsic motivation", "medication compliance", "men", "novel", "novel strategies", "pandemic disease", "phase 2 study", "phase 2 testing", "primary outcome", "recruit", "response", "screening", "smoking cessation" ], "approved": true } }, { "type": "Grant", "id": "8820", "attributes": { "award_id": "1R01FD007456-01", "title": "A Novel First-in-class 3D Printing Technology for Advanced Manufacturing of Complex Vaccine Formulations against Influenza and Emerging Infectious Diseases", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [], "program_reference_codes": [], "program_officials": [ { "id": 24621, "first_name": "Manuel", "last_name": "Osorio", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2021-09-01", "end_date": "2024-08-31", "award_amount": 498189, "principal_investigator": { "id": 24622, "first_name": "Mohammed", "last_name": "Maniruzzaman", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [ { "id": 972, "ror": "", "name": "UNIVERSITY OF TEXAS AT AUSTIN", "address": "", "city": "", "state": "TX", "zip": "", "country": "United States", "approved": true } ] }, "other_investigators": [], "awardee_organization": { "id": 972, "ror": "", "name": "UNIVERSITY OF TEXAS AT AUSTIN", "address": "", "city": "", "state": "TX", "zip": "", "country": "United States", "approved": true }, "abstract": "PROJECT SUMMARY: Vaccination is known to be the most effective strategy to manage the spread and deleterious impact of various infectious diseases including the most recent emerging, coronavirus disease 2019, COVID-19. Recombinant protein subunit vaccines have demonstrated promising results for immunization against infectious diseases recently. These vaccines are manufactured through recombinant DNA technology in which the gene fragment that encodes the production of the recombinant protein is introduced to a host cell as an expression system. The genetically engineered cells can proliferate and produce a high amount of the protein of the target which can be separated and purified in the succeeding steps. The recent progress in genetic tool development to manipulate the microorganisms and utilization of mammalian cell lines in biopharmaceutical manufacturing have projected the global protein markets to reach $228.4 billion by the end of this year. However, this industry is still overloaded with processes that lack flexibility and process controls or integration needed for continuous or on demand production capacity. There is no biomanufacturing system that can produce recombinant proteins through a single-step continuous manufacturing process. So, due to the high demand for vaccines all over the world, there’s an immense need for highly efficient yet inexpensive technologies. Yeast expression systems such as Pichia pastoris (P. pastoris) can be used as an expression host cell which offers numerous advantages over traditional systems including high growth rate, easy genetic manipulation process, high yield protein expression, performing eukaryotic post-translational modifications, appropriate protein folding and protein secretion in the external medium and easy purification process.In this project we will utilise a novel Sprayed Multi Adsorbed-particle Reposing Technology (SMART 3D printing technique to produce biocompatible Pluronic (F127)-bisurethane methacrylate (F127-BUM) polymers based microcarrier immobilised with P. pastoris which can be used in large-scale fermentations for production of recombinant proteins. Our SMART technology meets the requirements for recombinant proteins manufacturing such as ease of scale-up, correct protein folding, and short post-production processing. It also has the potential to improve agility, flexibility, cost, and robustness in the manufacturing processes for complex protein-based biologics.Additionally, in contrast to other particulate fabrication techniques, SMART can incorporate live cells during the single-step microparticle formulation process. This technology can easily host further ancillary processes such as ultra-low temperature freezing print bed (-80oC or lower), fibre optic probes for the inline monitoring of critical product quality attributes (CQAs) such as viscosity, content uniformity and stability, making it accessible to industry in the near term with a robust control strategy. Our SMART will be implemented in a continuous setup to manufacture dry powder bioengineered P. pastoris encapsulated F127-BUM microcarriers to produce recombinant proteins for infectious diseases such as vaccines against Epstein-Barr virus (EBV) and influenza vaccines.", "keywords": [], "approved": true } }, { "type": "Grant", "id": "10567", "attributes": { "award_id": "1R43MH130305-01A1", "title": "A novel digital platform for measurement-based peer supervision of non-specialist providers conducting brief psychological interventions", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Institute of Mental Health (NIMH)" ], "program_reference_codes": [], "program_officials": [ { "id": 26585, "first_name": "Maggie", "last_name": "Sweeney", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2022-09-07", "end_date": "2023-09-06", "award_amount": 259467, "principal_investigator": { "id": 22839, "first_name": "Y. Xian XIAN", "last_name": "Ho", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [ { "id": 1543, "ror": "", "name": "DIMAGI, INC.", "address": "", "city": "", "state": "MA", "zip": "", "country": "United States", "approved": true } ] }, "other_investigators": [ { "id": 26586, "first_name": "Neal", "last_name": "Lesh", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "awardee_organization": { "id": 1543, "ror": "", "name": "DIMAGI, INC.", "address": "", "city": "", "state": "MA", "zip": "", "country": "United States", "approved": true }, "abstract": "Unmet mental health needs continue to be a significant public health challenge in the US and the increase in reported adverse mental health conditions associated with the onset of the Covid-19 pandemic have likely exacerbated this problem. We propose a reverse innovation solution to digitize an evidence-based task sharing approach for treating depression in individuals from underserved communities, where health inequities are most pronounced due to a shortage of mental health specialists and lack of access to resources. The digital platform will be designed to host a suite of tools to support measurement-based peer supervision (MBPS), which includes the ability for non-specialist providers (NSPs) to record therapy sessions, rate sessions using a validated quality scale, and review ratings safely and securely with peers in moderated group discussions. Target end users will be NSPs who are trained on a behavioral activation program which has been successfully implemented in India to treat depression. The goal of this Phase I project is to demonstrate acceptability and feasibility of the proposed digital solution. We will address this goal with two specific aims. In Aim 1, we will work in close collaboration with experts in MBPS and an advisory group of NSPs to determine design requirements and develop a prototype of the digital solution. In Aim 2, a purposive sample target end users (i.e., NSPs trained in behavioral activation) will test the prototype developed in Aim 1. We will use mixed methods (interviews, surveys, passive usage data) to probe usability and user experience and identify barriers and facilitators to implementation. Results from Phase I will inform a potential Phase II project to study the digital platform’s implementation at scale and its effect on NSP performance with the long-term goal of improving mental health outcomes, particularly in hard-to-reach communities that can benefit the most from NSP-led support.", "keywords": [ "Address", "Behavioral", "Benchmarking", "COVID-19 pandemic", "Caring", "Collaborations", "Communities", "Community Health Aides", "Data", "Data Storage and Retrieval", "Development", "Effectiveness", "Ensure", "Feedback", "Focus Groups", "Future", "Goals", "Group Interviews", "Group Structure", "Health Personnel", "Incidence", "India", "Individual", "Industry", "Intervention", "Interview", "Measurement", "Measures", "Mental Depression", "Mental Health", "Mental Health Services", "Methods", "Nurses", "Outcome", "Paper", "Participant", "Peer Group", "Performance", "Persons", "Phase", "Predictive Analytics", "Primary Care Physician", "Prize", "Process", "Professional counselor", "Provider", "Psychiatrist", "Psychologist", "Public Health", "Qualitative Methods", "Quality of Care", "Readiness", "Recommendation", "Recovery", "Reporting", "Resources", "Sampling", "Secure", "Self Efficacy", "Series", "Services", "Small Business Innovation Research Grant", "Specialist", "Standardization", "Supervision", "Support System", "Surveys", "System", "Testing", "Texas", "Therapeutic", "Training", "Travel", "Work", "acceptability and feasibility", "base", "behavioral health", "commercialization", "cost", "depressive symptoms", "design", "digital", "effectiveness evaluation", "effectiveness measure", "evidence base", "experience", "field study", "gaps in access", "health inequalities", "implementation facilitators", "improved", "innovation", "insight", "intervention program", "iterative design", "medical schools", "member", "mobile application", "novel", "peer", "programs", "promoter", "prototype", "psychologic", "quality assurance", "skill acquisition", "statistics", "success", "teacher", "therapy duration", "tool", "underserved community", "usability", "web app" ], "approved": true } } ], "meta": { "pagination": { "page": 1383, "pages": 1419, "count": 14184 } } }