Grant List
Represents Grant table in the DB
GET /v1/grants?page%5Bnumber%5D=4&sort=-award_amount
{ "links": { "first": "https://cic-apps.datascience.columbia.edu/v1/grants?page%5Bnumber%5D=1&sort=-award_amount", "last": "https://cic-apps.datascience.columbia.edu/v1/grants?page%5Bnumber%5D=1397&sort=-award_amount", "next": "https://cic-apps.datascience.columbia.edu/v1/grants?page%5Bnumber%5D=5&sort=-award_amount", "prev": "https://cic-apps.datascience.columbia.edu/v1/grants?page%5Bnumber%5D=3&sort=-award_amount" }, "data": [ { "type": "Grant", "id": "10217", "attributes": { "award_id": "75N91019D00024-0-759102200007-1", "title": "Phase 2 COVID-19 Vaccine Variant Clinical Trial", "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": [], "start_date": "2022-03-07", "end_date": "2024-03-06", "award_amount": 36854529, "principal_investigator": { "id": 26171, "first_name": "THERESA", "last_name": "ENGEL", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [], "awardee_organization": { "id": 1610, "ror": "", "name": "LEIDOS BIOMEDICAL RESEARCH, INC.", "address": "", "city": "", "state": "MD", "zip": "", "country": "United States", "approved": true }, "abstract": "To support a Phase 2 clinical trial evaluating various additional COVID-19 booster shots, the COVID-19 Variant Immunologic Landscape (COVAIL) clinical trial.", "keywords": [ "2019-nCoV", "COVID-19", "COVID-19 booster", "COVID-19 vaccine", "Clinical Trials", "Immunologics", "Phase", "Phase II Clinical Trials", "SARS-CoV-2 variant", "Vaccine Research", "Variant", "booster vaccine" ], "approved": true } }, { "type": "Grant", "id": "9204", "attributes": { "award_id": "4U24MD016258-02", "title": "RADx-UP CDCC", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "NIH Office of the Director" ], "program_reference_codes": [], "program_officials": [ { "id": 7440, "first_name": "DOROTHY M", "last_name": "CASTILLE", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2020-09-27", "end_date": "2024-12-31", "award_amount": 36243390, "principal_investigator": { "id": 23601, "first_name": "Michael", "last_name": "Cohen-Wolkowiez", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [ { "id": 246, "ror": "https://ror.org/00py81415", "name": "Duke University", "address": "", "city": "", "state": "NC", "zip": "", "country": "United States", "approved": true } ] }, "other_investigators": [ { "id": 23602, "first_name": "Giselle", "last_name": "Corbie-Smith", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, { "id": 23603, "first_name": "WARREN A.", "last_name": "KIBBE", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "awardee_organization": { "id": 246, "ror": "https://ror.org/00py81415", "name": "Duke University", "address": "", "city": "", "state": "NC", "zip": "", "country": "United States", "approved": true }, "abstract": "There is an urgent need to reduce disparities in COVID-19 associated morbidity and mortality outcomes in historically marginalized and vulnerable populations disproportionately affected by the COVID-19 pandemic. To address this need the Rapid Acceleration of Diagnostics for Underserved Populations (RADx-UP) program will support Community-Engaged Testing Research Projects and Social, Ethical and Behavioral Implications (SEBI) Research Projects to understand SARS-CoV-2 infection patterns and increase access and effectiveness of diagnostic methods in underserved and/or vulnerable populations. The Duke Clinical Research Institute (DCRI), the UNC Center for Health Equity Research (CHER), and Community-Campus Partnerships for Health (CCPH) propose to serve as the Coordination and Data Collection Center (CDCC) to provide management, direction, and overall coordination of the RADx-UP consortium. Together, our multidisciplinary experience in project coordination; COVID-19 thought leadership; regulatory science; community engagement; health equity research; social justice; adult and child research; statistics; data science; and clinical research informatics will advance the objectives of the projects in the RADx-UP Program. Our overarching goal is to implement a community-centered approach and establish an effective, flexible, participatory, and sustainable CDCC that will serve as the infrastructure to maximize the community impact of projects in the RADx-UP Program. To achieve this vision, we will establish a program framework comprised of four cores. Our Administration and Coordination Core, in collaboration with NIH scientific staff, will facilitate the work of the RADx-UP Program in overarching administrative management. The COVID-19 Testing Core will advise and guide COVID-19 testing protocols; curate emergent testing data; and administer the Rapid Pilot Studies Program. The Community and Health System Engagement Core will support a community of practice across the RADx-UP Program; provide support in exchanging best practices across communities on recruitment, engagement, and retention of study participants; and coordinate the dissemination of study findings from RADx-UP projects. The Data Science and Biostatistics Core will manage data collection, integration, and sharing for the RADx-UP Program including merging and harmonization of multiple and diverse data sources and provide data standards, data collection design, and biostatistics consulting services. The RADx-UP CDCC goals will be met using established infrastructure and subject matter experts and will be customized to meet the variable needs of the RADx-UP community. Using the highest research standards, our team will accomplish the goals set out by the NIH in managing this critically important collaborative effort.", "keywords": [ "2019-nCoV", "Address", "Adult", "Affect", "Back", "Behavioral", "Biometry", "Biostatistics Core", "COVID-19", "COVID-19 morbidity", "COVID-19 pandemic", "COVID-19 testing", "Cessation of life", "Child", "Clinical Research", "Collaborations", "Communities", "Community Health Systems", "Community of Practice", "Consult", "Custom", "Data", "Data Collection", "Data Science", "Data Sources", "Diagnostic Procedure", "Effectiveness", "Ensure", "Ethics", "Funding", "Future", "Goals", "Health", "Inequality", "Informatics", "Infrastructure", "Leadership", "Office of Administrative Management", "Outcome", "Participant", "Pattern", "Pilot Projects", "Plant Roots", "Population Programs", "Protocols documentation", "Public Health", "RADx Underserved Populations", "Research", "Research Institute", "Research Personnel", "Research Project Grants", "Research Support", "SARS-CoV-2 infection", "Science", "Scientific Advances and Accomplishments", "Services", "Social Justice", "Structure", "Testing", "Underserved Population", "United States National Institutes of Health", "Universities", "Virus", "Vision", "Vulnerable Populations", "Work", "community center", "community engaged research", "community engagement", "data management", "data repository", "data standards", "design", "disparity reduction", "diverse data", "experience", "flexibility", "health disparity", "health equity", "improved", "infrastructure development", "interest", "lens", "marginalized population", "mortality", "multidisciplinary", "pandemic disease", "prevent", "programs", "recruit", "social", "statistics" ], "approved": true } }, { "type": "Grant", "id": "7704", "attributes": { "award_id": "3UL1TR002243-04S3", "title": "Passive Immunity Trial for Our Neighbors (PassITON): A randomized, placebo-controlled multi-site trial of anti-SARS-CoV-2 convalescent plasma to treat hospitalized adults with COVID-19", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Center for Advancing Translational Sciences (NCATS)" ], "program_reference_codes": [], "program_officials": [ { "id": 21334, "first_name": "Rashmi", "last_name": "Gopal-Srivastava", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2017-06-01", "end_date": "2022-02-28", "award_amount": 34000000, "principal_investigator": { "id": 23495, "first_name": "Gordon R", "last_name": "Bernard", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [ { "id": 456, "ror": "https://ror.org/05dq2gs74", "name": "Vanderbilt University Medical Center", "address": "", "city": "", "state": "TN", "zip": "", "country": "United States", "approved": true } ] }, "other_investigators": [ { "id": 23394, "first_name": "CONSUELO HOPKINS", "last_name": "WILKINS", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "awardee_organization": { "id": 456, "ror": "https://ror.org/05dq2gs74", "name": "Vanderbilt University Medical Center", "address": "", "city": "", "state": "TN", "zip": "", "country": "United States", "approved": true }, "abstract": "The Vanderbilt Institute for Clinical and Translational Research (VICTR) is a highly functional and integrated clinical and translational (C&T) research infrastructure that has raised the quality and scientific rigor of the research conducted at Vanderbilt and longstanding partner Meharry, the nation's oldest historically black academic health science institution. VICTR will contribute to the mission of the CTSA program while leveraging unique resources and expertise within VICTR's Hub with these aims: 1) Leverage VICTR's strong collaborative energy to enhance team science methodologies that propel transdisciplinary research approaches, and integrate proven community engagement principles to stakeholders for all stages of research; 2) Develop, implement and disseminate informatics and data organization methods to promulgate research efficiency, quality, and preparedness and integrate data collection in the conduct of pragmatic trials; 3) Ensure the translational science workforce is diverse and has the skills, knowledge, and resources necessary to advance translation of discoveries; 4) Measurably improve the efficiency, quality, and representativeness of C&T studies by enhancing and systematically integrating services and programs that support highest quality research initiation and conduct; 5) Measurably improve the efficiency and quality of multi-site clinical trials, in collaboration with the TICs and RICs, by leveraging centralized regulatory and legal agreements, providing rapid feasibility and recruitment methods and practices, and creating and disseminating novel clinical trial designs and methodologies; and 6) Utilize unique strengths leveraging novel resources BioVU and PheWAS to guide drug development and repurposing.", "keywords": [ "2019-nCoV", "Adult", "Affect", "Agreement", "COVID-19", "COVID-19 pandemic", "Cessation of life", "Clinical", "Clinical Research", "Clinical Trials Design", "Collaborations", "Communities", "Data", "Data Collection", "Effectiveness", "Ensure", "Health Sciences", "Individual", "Infection", "Informatics", "Inpatients", "Institutes", "Institution", "Knowledge", "Legal", "Measurable", "Medical", "Methodology", "Methods", "Mission", "Multi-Institutional Clinical Trial", "Passive Immunity", "Placebos", "Plasma", "Randomized", "Readiness", "Research", "Research Infrastructure", "Resources", "Safety", "Science", "Translational Research", "Translations", "United States", "Validation", "Virus", "clinical efficacy", "drug development", "high risk", "improved", "mortality risk", "multi-site trial", "novel", "patient subsets", "pragmatic trial", "programs", "randomized placebo-controlled clinical trial", "recruit", "service programs", "skills", "translational study" ], "approved": true } }, { "type": "Grant", "id": "15243", "attributes": { "award_id": "1U19AI181968-01", "title": "The UCI Vaccines for Pandemic Preparedness Center (VPPC)", "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": 31830, "first_name": "Genevieve Anne", "last_name": "Holzapfel", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2024-08-20", "end_date": "2027-07-31", "award_amount": 33116067, "principal_investigator": { "id": 31831, "first_name": "PHILIP Louis", "last_name": "FELGNER", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [], "awardee_organization": { "id": 971, "ror": "", "name": "UNIVERSITY OF CALIFORNIA-IRVINE", "address": "", "city": "", "state": "CA", "zip": "", "country": "United States", "approved": true }, "abstract": "– Overall: The UCI Vaccines for Pandemic Preparedness Center (VPPC) The Mission: \"To contribute to human health and well-being by developing agile, safe, effective and accessible vaccines that protect the vulnerable against future pathogens of pandemic importance and by educating the next generation of vaccine scientists that will tackle such challenges.” Joshua Lederberg envisioned the world as a battlefield between microbes and man, famously saying, “The future of humanity and microbes likely will unfold as episodes of a suspense thriller that could be titled Our Wits Versus Their Genes” (Lederberg, 2000). Although the genes of the microbial world have been evolving much longer than our wits, we have come up with efficient ways to respond to infectious diseases, but regrettably evolving microorganisms keep managing to challenge and outsmart us. The latest COVID episode in this series sensitized the world again to the importance of learning from the outbreak experience and challenges us to better prepare for the next one. The 100 Days Mission (100DM), endorsed by government and non-government organizations worldwide is a proposed response to the next “Disease X” by making safe, and effective vaccines available within 100 days of the pathogen’s identification. Achieving that goal could defuse the threat of a pathogen with pandemic potential. The International Pandemic Preparedness Secretariate (IPPS), the Coalition for Epidemic Preparedness Innovations (CEPI), the HHS Administration for Strategic Preparedness and Response (ASPR Next) and the NIH/NIAID have embraced the concept of studying prototype pathogens as a critical element of preparedness. By developing vaccines on rapid-response platforms against examples of a given viral genus or family, researchers can address scientific challenges characteristic of that family in advance, providing an important head start on developing vaccines against related threats. Universal programmable vaccine platforms that can be rapidly employed against broad virus families can be evaluated in clinical trials to provide confidence in their safety, and manufacturing, and regulatory considerations can be managed ahead of the next outbreak. The UC Irvine Vaccines for Pandemic Preparedness Center (VPPC) aims to conduct basic and translational research to develop vaccines against prototype members of the Bunyavirus, Paramyxovirus and Picornavirus families with demonstrated immunogenicity and efficacy in animal models. Two universal, programmable, rapid response vaccine platforms will be characterized and compared in this study: the i) Adjuvanted Recombinant Protein (ARP) Vaccine, and ii) mRNA/Lipid Nanoparticle (LNP) Vaccine. Such prototype vaccines will need to be tested in advance, at a minimum, for clinical safety and immunogenicity, and efficacy where possible, so that emerging viruses in the same family can be rapidly and safely deployed. Gathering such data and experience will build confidence in these rapid response platforms and inform regulators as they make decisions about the emergency authorization of vaccines against related pathogens.", "keywords": [], "approved": true } }, { "type": "Grant", "id": "9045", "attributes": { "award_id": "3U54EB027690-02S1", "title": "Emergency COVID-19 supplement for Atlanta Center for Microsystems Engineered Point-of-Care Technoloites (ACME POCT)", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Institute of Biomedical Imaging and Bioengineering (NIBIB)" ], "program_reference_codes": [], "program_officials": [ { "id": 6433, "first_name": "Tiffani Bailey", "last_name": "Lash", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2020-05-22", "end_date": "2021-05-21", "award_amount": 31080737, "principal_investigator": { "id": 15708, "first_name": "Oliver", "last_name": "Brand", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [ { "id": 265, "ror": "https://ror.org/03czfpz43", "name": "Emory University", "address": "", "city": "", "state": "GA", "zip": "", "country": "United States", "approved": true } ] }, "other_investigators": [ { "id": 22968, "first_name": "Wilbur A", "last_name": "Lam", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, { "id": 22969, "first_name": "GREGORY S", "last_name": "MARTIN", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "awardee_organization": { "id": 265, "ror": "https://ror.org/03czfpz43", "name": "Emory University", "address": "", "city": "", "state": "GA", "zip": "", "country": "United States", "approved": true }, "abstract": "The advent of point-of-care (POC) diagnostic capabilities has enabled rapid and timely clinical evaluation in the physician's office, an ambulance, the home, the field, or in the hospital and has the potential to significantly impact health care delivery. In cardiology, pulmonology/critical care, and hematology, POC testing plays an especially significant role as the heart and lungs are among the most vital of organs necessitating real time diagnosis and rapid management during critical illnesses, while pathologic alternations in blood are associated with critical, systemic illness. One class of novel medical technologies that is showing promise for POC applications are microsystems-engineered technologies, that is, microchip-enabled devices ranging from microelectromechanical systems (MEMs)-based sensors, microfluidics, to even smartphone-based systems. Notable for their small size and power requirements, microchip-based systems provide the portability that is vital for POC testing. In addition, the capability of microsystems to convert sound and movement into electrical signals enable these technologies to be ideal devices to sense the dynamics of the lungs and heart and therefore to diagnose and monitor pulmonary and cardiac disorders. Moreover, microsystems engineering has brought forth the field of microfluidics, which is steadily finding applications for blood-based diagnostics, and therefore, hematologic applications. To that end, per the NHLBI's U54 POCTRN guidelines, the overall goal of the Atlanta Center for Microsystems Engineered POC Technologies (ACME POCT) is to assist and enable inventors from across the country who have developed microsystems-based POC technologies for cardiac, pulmonary, hematologic and sleep applications that are beyond proof-of-concept to define their specific clinical needs, conduct clinical validation, and refine their technology, with the objective of accelerating the path to translation and clinical adoption and directly addressing the barriers thereof. The ACME POCT uniquely leverages Atlanta's nationally top-ranked clinical programs at Emory University's hospitals and Children's Healthcare of Atlanta, one of the nation's largest pediatric hospital systems, as well the internationally acclaimed microsystems engineering expertise at Georgia Tech, which includes the Institute for Electronics and Nanotechnology (IEN), and other one-of-a-kind medical device prototyping, innovation, and testbed facilities. The ACME POCT PI's uniquely balance the engineering and clinical sides of the Center and comprise Wilbur Lam, MD, PhD, a clinical hematologist at Emory and Georgia Tech bioengineer with expertise in POC diagnostic development and commercialization, Oliver Brand, PhD, a renowned microsystems engineer and head of Georgia Tech's IEN, and Greg Martin, MD, MSc, a clinical pulmonologist at Emory and head of clinical research in Atlanta's NIH-funded CTSA. Importantly, the leadership of the ACME POCT has a history of collaboration and track record in managing Centers that have fostered medical device development.", "keywords": [ "Address", "Adoption", "Ambulances", "American", "Bedside Testings", "Biomedical Engineering", "Blood", "COVID-19", "Cardiac", "Cardiology", "Care Technology Points", "Cellular Phone", "Child health care", "Clinical", "Clinical Research", "Clinical and Translational Science Awards", "Collaborations", "Country", "Critical Care", "Critical Illness", "Development", "Device or Instrument Development", "Devices", "Diagnosis", "Diagnostic", "Diagnostic tests", "Doctor of Philosophy", "Electronics", "Emergency Situation", "Engineering", "Equilibrium", "Fostering", "Funding", "Goals", "Guidelines", "Head", "Heart", "Heart Diseases", "Hematologist", "Hematology", "Home environment", "Hospitals", "Institutes", "International", "Leadership", "Lung", "Lung diseases", "Medical Device", "Medical Technology", "Microfluidics", "Monitor", "Movement", "Nanotechnology", "National Heart Lung and Blood Institute", "Organ", "Pathologic", "Pediatric Hospitals", "Physicians&apos", "Offices", "Play", "Population", "Pulmonology", "Recording of previous events", "Role", "Running", "Schools", "Side", "Signal Transduction", "Sleep", "System", "Technology", "Time", "Translations", "United States National Institutes of Health", "University Hospitals", "Validation", "Work", "base", "commercialization", "health care delivery", "innovation", "microchip", "microsystems", "novel", "point of care", "point-of-care diagnostics", "portability", "programs", "prototype", "public health relevance", "research clinical testing", "sensor", "sound" ], "approved": true } }, { "type": "Grant", "id": "9080", "attributes": { "award_id": "3UM1AI068618-14S1", "title": "HVTN 405/HPTN 1901 Characterizing SARS-CoV-2-specific immunity in convalescent individuals: LC", "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": 6974, "first_name": "Patricia D.", "last_name": "D'Souza", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2020-06-24", "end_date": "2022-11-30", "award_amount": 29952323, "principal_investigator": { "id": 6975, "first_name": "Margaret Juliana", "last_name": "McElrath", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [ { "id": 757, "ror": "", "name": "FRED HUTCHINSON CANCER RESEARCH CENTER", "address": "", "city": "", "state": "WA", "zip": "", "country": "United States", "approved": true } ] }, "other_investigators": [], "awardee_organization": { "id": 757, "ror": "", "name": "FRED HUTCHINSON CANCER RESEARCH CENTER", "address": "", "city": "", "state": "WA", "zip": "", "country": "United States", "approved": true }, "abstract": "This proposal outlines the scientific agenda for the Leadership and Operations Center of the HIV Vaccine Trials Network (HVTN), the collaboration of physician scientists at 64 clinical trial sites in 15 countries on 4 continents dedicated to developing globally effective vaccines for HIV, tuberculosis and now SARS-CoV-2. The HVTN has led HIV prevention science for over 20 years through robust phase 1 and 2 clinical development trials and currently has 2 vector based vaccines (ALVAC and Ad26) and 1 broadly neutralizing monoclonal antibody (mAb) VRC01 undergoing testing in 5 randomized controlled efficacy trials. 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 (eg, 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.", "keywords": [ "2019-nCoV", "AIDS prevention", "ALVAC", "Acute", "Adult", "Age-Years", "Biological Assay", "Biometry", "COVID-19", "COVID-19 pandemic", "COVID-19 vaccine", "Cells", "Cellular Assay", "Chronic", "Clinical", "Clinical Trials", "Cohort Studies", "Collaborations", "Communicable Diseases", "Country", "Development", "Disease", "Disease Outbreaks", "Epitopes", "Eye", "Future", "Goals", "HIV Vaccine Trials Network", "HIV vaccine", "HIV/TB", "Health", "Immune", "Immune response", "Immune system", "Immunity", "Immunologic Markers", "Immunologics", "Immunology", "Immunology procedure", "Immunotherapeutic agent", "Individual", "Infection", "Infection Control", "Infection prevention", "Inflammation", "Intubation", "Joints", "Knowledge", "Laboratories", "Lead", "Leadership", "Light", "Malaria", "Measures", "Mediating", "Medical", "Medical History", "Monoclonal Antibodies", "Monoclonal Antibody Therapy", "Morbidity - disease rate", "Myocarditis", "National Institute of Allergy and Infectious Disease", "Participant", "Pathologic", "Pericarditis", "Persons", "Peru", "Pharmaceutical Preparations", "Phase", "Physicians", "Play", "Population", "Preparation", "Prevention", "Preventive vaccine", "Prospective Studies", "Protocols documentation", "Quality Control", "Randomized", "Randomized Clinical Trials", "Reagent", "Research Methodology", "Risk", "Role", "Sampling", "Science", "Scientist", "Series", "Serological", "Severity of illness", "Site", "Specificity", "System", "Testing", "Typhoid Fever", "United States", "Vaccination", "Vaccines", "Validation", "Virus", "Virus Diseases", "Virus Shedding", "adaptive immune response", "clinical development", "clinical trial analysis", "cohort", "coronavirus disease", "design", "efficacy study", "efficacy trial", "experience", "illness length", "immune function", "improved", "interest", "mortality", "neutralizing monoclonal antibodies", "neutralizing vaccine", "operation", "pandemic disease", "prevent", "programs", "quality assurance", "recruit", "response", "therapeutic vaccine", "vaccine trial", "vector-based vaccine", "virology" ], "approved": true } }, { "type": "Grant", "id": "9302", "attributes": { "award_id": "75N92020C00029-P00002-9999-1", "title": "RADX-TECH - LUMINOSTICS, INC. SMARTPHONE-BASED TEST FOR RAPID SARS-COV-2 ANTIGEN DETECTION FROM NASAL SWABS", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Institute of Biomedical Imaging and Bioengineering (NIBIB)", "NIH Office of the Director" ], "program_reference_codes": [], "program_officials": [], "start_date": "2020-09-30", "end_date": "2021-09-29", "award_amount": 28624460, "principal_investigator": { "id": 25043, "first_name": "BALA", "last_name": "RAJA", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [ { "id": 1571, "ror": "", "name": "LUMINOSTICS, INC.", "address": "", "city": "", "state": "CA", "zip": "", "country": "United States", "approved": true } ] }, "other_investigators": [], "awardee_organization": { "id": 1571, "ror": "", "name": "LUMINOSTICS, INC.", "address": "", "city": "", "state": "CA", "zip": "", "country": "United States", "approved": true }, "abstract": "Luminostics (San Jose, CA) is leveraging our de-risked and scale-ready smartphone-based diagnostics platform to develop a 15-minute smartphone-readout over-the-counter diagnostic self-test for the accurate detection of SARS-CoV-2 antigens from respiratory specimens (preferred sample type shallow nasal swab). We aim to obtain FDA EUA for this test by October 2020 and build a manufacturing capacity of >250k tests/week by November 2020. The assay & chemistry of this OTC test will be de-risked earlier through a a point-of-care version of the same product (EUA in July 2020). Luminostics has developed a platform for high-sensitivity lateral flow immunoassays (LFAs) which is capable of orders-of-magnitude lower limits of detection (LoDs) compared to visually-read LFAs—and therefore higher clinical sensitivities approaching RT-PCR—using only a consumer smartphone’s optics, controlled by an app and paired with an inexpensive adapter, for readout. Our platform’s high sensitivity is enabled by the high detectability, with cheap optics, of our patented “glow-in-the-dark†persistent luminescent nanoparticles (“nanophosphorsâ€) in combination with highly optimized signal acquisition and processing algorithms. This means we can detect and quantify >100-fold lower levels of an analyte at the same per-test cost of a visual-readout LFA using the same affinity reagents, thereby enabling significant gains in clinical sensitivity. Our previous work has shown that this platform is ~90% sensitive and 99% specific for Chlamydia trachomatis detection compared to lab-based nucleic acid amplification testing methods in large clinical studies (N=437), enabling rapid, ultrasensitive, and portable diagnostics. We have also demonstrated superior anlaytical performance over existing rapid tests for other bacterial/viral pathogens.", "keywords": [ "Affinity", "Algorithms", "Biological Assay", "COVID-19 detection", "Cellular Phone", "Chemistry", "Chlamydia trachomatis", "Clinical Research", "Clinical Sensitivity", "Detection", "Diagnostic", "FDA Emergency Use Authorization", "Immunoassay", "Lateral", "Legal patent", "Methods", "Nucleic Acid Amplification Tests", "Optics", "Performance", "RADx Tech", "Reagent", "Risk", "SARS-CoV-2 antigen", "Sampling", "Signal Transduction", "Specimen", "Testing", "Visual", "Work", "antigen detection", "base", "cost", "detection limit", "diagnostic platform", "nanoparticle", "nasal swab", "pathogenic virus", "point of care", "portability", "rapid test", "respiratory", "self testing" ], "approved": true } }, { "type": "Grant", "id": "4271", "attributes": { "award_id": "1639145", "title": "The National Socio-Environmental Synthesis Center (SESYNC): Advancing socio-environmental research through computational, theoretical, and interdisciplinary science", "funder": { "id": 3, "ror": "https://ror.org/021nxhr62", "name": "National Science Foundation", "approved": true }, "funder_divisions": [ "Biological Sciences (BIO)", "Environmental Synthesis Center" ], "program_reference_codes": [], "program_officials": [ { "id": 14458, "first_name": "Elizabeth", "last_name": "Blood", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2016-09-01", "end_date": "2023-02-28", "award_amount": 28200000, "principal_investigator": { "id": 14459, "first_name": "Margaret", "last_name": "Palmer", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [ { "id": 297, "ror": "https://ror.org/047s2c258", "name": "University of Maryland, College Park", "address": "", "city": "", "state": "MD", "zip": "", "country": "United States", "approved": true } ] }, "other_investigators": [], "awardee_organization": { "id": 297, "ror": "https://ror.org/047s2c258", "name": "University of Maryland, College Park", "address": "", "city": "", "state": "MD", "zip": "", "country": "United States", "approved": true }, "abstract": "Equitable, ethical, and sustainable uses of the Earth's finite resources require an understanding of how human behaviors affect and respond to the environment. The National Socio-Environmental Synthesis Center (SESYNC) facilitates novel research across the natural and social sciences to achieve this understanding and to provide the knowledge needed to address complex problems challenging human societies globally. The Center will develop education and training activities to build capacity across all career stages to solve complex problems and to develop a new generation of researchers skilled in collaboration and communication. These activities will emphasize the relevance of socio-environmental synthesis to real world problems by including policy-makers, governmental agencies, and non-governmental agencies in all activities, ensuring that these knowledge users obtain the information they need to make sound decisions. New investments will train thought leaders, educators, and decision-makers of the future. Building capacity extends to increased involvement of under-served groups in solving societal problems. Partnerships with Historically Black Colleges and Universities, coupled with active mentoring of their undergraduates and faculty, will engage these communities in environmental challenges that have significant cultural, economic, and social implications. Center activities will build computational literacy and provide publicly-available analytical tools that will advance computational training far beyond SESYNC's participants. Through a suite of new activities, SESYNC will build capacity to find solutions to pressing societal challenges. \n\nSESYNC has established itself as a pioneer in the integrative, computationally intensive, and trans-disciplinary research that defines a new biology for the 21st century. Its approach for the future relies on a firmly vetted and established approach to synthesis developed over 5 years of experiment and testing. Activities focus on developing a community of practice for socio-environmental synthesis. New partnerships with Historically Black Colleges and Universities will establish workshops, collaborative synthesis projects, and a peer faculty-student network to foster exchange of ideas, provide intellectual and moral support, and facilitate access to professional development and research opportunities. A new postdoctoral program focuses on 'immersion' to accelerate development of integrated, inter-disciplinary research projects. Fellows will first initiate a project in their own discipline and then be quickly immersed, through lectures and workshops, in the theory and practice of related disciplines. Graduate students will direct their own synthesis working groups to develop skills in collaboration and communication early in their careers. Diverse efforts to track participants will sustain their involvement in socio-environmental synthesis after leaving SESYNC. A new cyberinfrastructure program, Data to Motivate Synthesis, will use facilitated data discovery and team science workshops to formulate research questions at the interface of social-natural sciences. A new collaboration with Georgetown University's Environmental Initiative will strengthen SESYNC's 'actionable' scholarship portfolio and further broaden participation in socio-environmental synthesis. The two institutions will co-support four postdoctoral fellows to conduct synthesis research on science-policy links. The success of all activities will be measured against established goals and milestones through formative and summative assessment.", "keywords": [], "approved": true } }, { "type": "Grant", "id": "8642", "attributes": { "award_id": "3U19AI110483-08S4", "title": "ACE Covid 19 Admin Supplement: Molecular Regulation of B cells and T cells in Human SLE", "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": 7372, "first_name": "David R.", "last_name": "Johnson", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2021-08-27", "end_date": "2023-04-30", "award_amount": 26794157, "principal_investigator": { "id": 7373, "first_name": "Ignacio E.", "last_name": "Sanz", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [ { "id": 265, "ror": "https://ror.org/03czfpz43", "name": "Emory University", "address": "", "city": "", "state": "GA", "zip": "", "country": "United States", "approved": true } ] }, "other_investigators": [], "awardee_organization": { "id": 265, "ror": "https://ror.org/03czfpz43", "name": "Emory University", "address": "", "city": "", "state": "GA", "zip": "", "country": "United States", "approved": true }, "abstract": "COVID 19 Vaccination Trial (ACV01) Emory requests an Admin Supplement (AS) to support the ACE COVID-19 vaccination trial (ACV01) and study. Below, first the major components are listed and described briefly, then budgeting details are provided. There are three major components of the AS: 1. ACV01 interventional clinical trial of COVID-19 vaccines in patients with autoimmune diseases. a. $10 M completed protocol with investigators, sites, and detailed budget for first cohorts (5 autoimmune diseases, 3 therapies, 3 vaccines). b. $10 M additional for the ‘adaptive’ cohorts that will be identified within the first half year. c. The protocol for the initial cohorts is complete and under review at FDA (anticipated July 12). d. Appendix: protocol 2. Statistical and Clinical Coordinating Center support (Rho Federal Systems) a. $4.5 M for subcontracting from Emory to Rho after their contract ends April 30, 2022. b. Rho will submit separately a detailed budget ($4 M expected) for support during the initial period. 3. ACV02 observational clinical study of COVID-19 vaccines in patients with autoimmune diseases. a. $2 M completed research plan protocol with lead investigators and sites; additional investigators will be recruited. b. The budget is currently scaled-up from a few essential procedures, such as blood draws, antisera measurements, and processing and storage. c. The samples will be used in more sophisticated assays later, which are beyond the scope of the current program and not supported by the current budget. d. Appendix: research plan Total request = $26 M The ACV01 clinical trial will enroll patients with 5 different autoimmune diseases (SLE, RA, MS, SSc, Pemphigus) on 3 different immunosuppressive therapies (aCD20, MTX, MMF) being randomized to several trial arms (e.g., withholding therapy during vaccination) to be vaccinated using one of at least 3 major vaccine providers (Pfizer/BioNTech, Moderna, Janssen, others expected). Patient visits are priced by combination of 4 parameters: disease + therapy + vaccine + arm of trial. The disease- and therapy- specific details are currently estimated based on visit time, personnel, and nature of the assessments.", "keywords": [ "Administrative Supplement", "Autoimmune Diseases", "B-Lymphocytes", "Biological Assay", "Blood", "Budgets", "COVID-19", "COVID-19 vaccination", "COVID-19 vaccine", "Clinical", "Clinical Research", "Clinical Trials", "Contracts", "Disease", "Enrollment", "Human", "Human Resources", "Immune Sera", "Intervention", "Lead", "Measurement", "Molecular", "Nature", "Patients", "Pemphigus", "Price", "Procedures", "Protocols documentation", "Provider", "Randomized", "Regulation", "Research", "Research Personnel", "Sampling", "Site", "System", "Systemic Lupus Erythematosus", "T-Lymphocyte", "Therapeutic immunosuppression", "Time", "Vaccinated", "Vaccination", "Vaccines", "Visit", "arm", "base", "cohort", "programs", "recruit", "rho", "scale up", "vaccine trial" ], "approved": true } }, { "type": "Grant", "id": "10100", "attributes": { "award_id": "2133504", "title": "NSF Engineering Research Center for Precision Microbiome Engineering (PreMiEr)", "funder": { "id": 3, "ror": "https://ror.org/021nxhr62", "name": "National Science Foundation", "approved": true }, "funder_divisions": [ "Engineering (ENG)", "ERC-Eng Research Centers" ], "program_reference_codes": [], "program_officials": [ { "id": 13927, "first_name": "Randy", "last_name": "Duran", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2022-09-01", "end_date": "2027-08-31", "award_amount": 26000000, "principal_investigator": { "id": 15419, "first_name": "Claudia", "last_name": "Gunsch", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [ { "id": 246, "ror": "https://ror.org/00py81415", "name": "Duke University", "address": "", "city": "", "state": "NC", "zip": "", "country": "United States", "approved": true } ] }, "other_investigators": [ { "id": 26002, "first_name": "Jennifer", "last_name": "Kuzma", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, { "id": 26003, "first_name": "Anthony A", "last_name": "Fodor", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, { "id": 26004, "first_name": "Jill R", "last_name": "Stewart", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, { "id": 26005, "first_name": "Joseph", "last_name": "Graves", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "awardee_organization": { "id": 246, "ror": "https://ror.org/00py81415", "name": "Duke University", "address": "", "city": "", "state": "NC", "zip": "", "country": "United States", "approved": true }, "abstract": "Microbes have colonized and adapted to most every environment on Earth, including the built environments that humans have created, such as the homes where we live and the pipes that bring us drinking water. It has been well established that microbial communities, or microbiomes, that colonize people have a direct influence on human health. The microbiome of the built environment, in particular, has gained increasing recognition for its key role in human health through its interaction with the human microbiome. However, despite this knowledge, no systematic infrastructure exists to decipher how microbial systems adapt to and grow within built environments, impeding our ability to diagnose built environment health and harness the power inherent to those microbiomes. The Engineering Research Center for Precision Microbiome Engineering (PreMiEr) will create microbiome-based diagnostic tools and develop microbiome engineering approaches to monitor and operate built environments that maximize human health protection. Informed by societal needs and research-stakeholder teams, PreMiEr’s research design will work to prevent the spread of infectious agents, promote the colonization of beneficial microorganisms, and lead to strategies for controlling pandemics and antibiotic resistance—phenomena that have led to over six million deaths worldwide (as of June 2022) and cost the global economy an estimated $8 trillion in the last year alone. Integral to its research vision, PreMiEr will create diverse and inclusive interdisciplinary research and training hubs where engineers, microbiologists, social scientists, and ethicists work alongside theorists, model builders, and computational scientists to develop technologies that enable transformative engineering discoveries in safe, sustainable and responsible ways.\n\nOur capacity to engineer microbiomes requires a fundamental understanding of concepts of community ecology and an ability to track, control, and model those interactions. To apply microbiome engineering to real-world systems, community level interactions must be integrated into a comprehensive, scalable modeling framework that requires iterative evaluation and validation in model testbeds. PreMiEr’s research organization is designed to generate fundamental understanding across these levels and functionalities, culminating in the development of a framework that enables the biodesign of smart and healthy built environments. PreMiEr will leverage advances in high-throughput genomic sequencing, high-resolution mass spectrometry, computational performance, and statistical modeling to unravel previously unknown mechanistic interactions. Enabling technologies will be developed to detect and define interactions in the built environment, including approaches that probe microbial dark matter for the development of built-environment health diagnostic tools; methods for targeted delivery of desired genetic features and microbial vectors; tools for fine in situ functional tuning; and predictive scalable statistical microbiome engineering models that consider high dimensionality, sparsity, and heterogeneity. These new technology elements will enable us to test hypotheses related to microbiome assembly and function. Importantly, by incorporating social scientists and ethicists into PreMiEr’s research framework, non-social scientists’ work will be informed by consideration of the ethical, societal, and policy implications of their microbiome engineering discoveries. Through rigorous evaluation and iterative refinement of curricula, and institutional practices designed to support a culture of convergence and the dissemination of findings, PreMiEr will contribute to best practices in domestic training. The PreMiEr ERC will include targeted recruitment of trainees from underrepresented groups, building upon existing partnerships with our nation’s largest HBCU, and will provide immersion in research and training at the interface of multiple disciplines to address complex challenges. PreMiEr will train the next generation of diverse and highly motivated engineers and scientists in technical and professional skills to compete in the emerging arenas of microbial science and engineering. Ultimately, our work will advance collaborations and discovery focused on environmental microbiomes to engineer healthy built environments.\n\nThis award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.", "keywords": [], "approved": true } } ], "meta": { "pagination": { "page": 4, "pages": 1397, "count": 13961 } } }