Grant List
Represents Grant table in the DB
GET /v1/grants?page%5Bnumber%5D=3&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=1392&sort=-award_amount", "next": "https://cic-apps.datascience.columbia.edu/v1/grants?page%5Bnumber%5D=4&sort=-award_amount", "prev": "https://cic-apps.datascience.columbia.edu/v1/grants?page%5Bnumber%5D=2&sort=-award_amount" }, "data": [ { "type": "Grant", "id": "6661", "attributes": { "award_id": "1U19AI171292-01", "title": "RAPIDLY EMERGING ANTIVIRAL DRUG DEVELOPMENT INITIATIVE- AViDD CENTER (READDI-AC)", "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": 22322, "first_name": "Tina M.", "last_name": "Parker", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2022-05-16", "end_date": "2025-04-30", "award_amount": 65483194, "principal_investigator": { "id": 22323, "first_name": "Ralph S", "last_name": "Baric", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [ { "id": 22324, "first_name": "timothy", "last_name": "willson", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "awardee_organization": { "id": 817, "ror": "", "name": "UNIV OF NORTH CAROLINA CHAPEL HILL", "address": "", "city": "", "state": "NC", "zip": "", "country": "United States", "approved": true }, "abstract": "PROGRAM SUMMARY/ABSTRACT Emerging viruses arise suddenly and cause considerable morbidity and mortality worldwide. To prepare for current and future threats, public-private partnerships are needed to change the current reactive response platform into one that is proactive. In response to RFA-AI-21-050, the Rapidly Emerging Antiviral Drug Development Initiatives AViDD Center (READDI-AC) is an integrated public-private partnership with a renowned, interdisciplinary research team of experts, who apply cutting edge innovative technologies in virology, biochemistry, structural biology, medicinal chemistry, computational biology, structure-guided drug design and genomics to develop oral, potent, broad-spectrum family-specific antivirals for coronaviruses, flaviviruses, alphaviruses and filoviruses. To achieve these goals, the READDI-AC program includes academic leaders in basic and applied antiviral research and chemistry as well as industry leaders Janssen Pharmaceuticals N.V.(JPNV), Takeda, Chimerix Inc. and Pardes Biosciences. Our commercial partners provide an enviable track records in drug discovery and product development, and leadership in medicinal chemistry, pharmacology, drug formulation, toxicity studies and pharmacokinetics, especially critical for driving optimized leads through preIND enabling studies toward the clinic. Importantly, our industry partners also provide in kind matching contributions, access to high quality commercial chemical libraries, early hits, optimized leads, and state of the art high- throughput screens. The immediate and long-term goals of READDI-AC are to: a) validate druggable targets in conserved viral proteins, b) identify hits and leads using SAR and state of the art biochemical and enzymatic assays, c) optimize/formulate chemical probes and lead compounds as broadly acting oral compounds with activity against multiple relevant members of each emerging virus family; d) provide critical late-stage preclinical development and IND-enabling in vivo studies for two broadly active, oral drug candidates; e) promote open science sharing of unused chemical assets, chemical probes, methods, reagents and assays for innovations by crowdsourcing; f) build capacity and training in 21st century viral drug discovery and development by coupling innovative approaches in target discovery and validation with state of the art techniques, integrated workflows and novel discovery platforms for hit to lead progression and SAR optimization. READDI-AC has five Research Projects and four highly interactive cores that establish a cooperative landscape that builds leadership, expertise, response capacity and partnerships that invigorate 21st century drug development.", "keywords": [ "2019-nCoV", "Address", "Alphavirus", "Amino Acid Motifs", "Antiviral Agents", "Automobile Driving", "Biochemical", "Biochemistry", "Biological Assay", "Biological Sciences", "Biophysics", "COVID-19", "COVID-19 pandemic", "Cessation of life", "Chemicals", "Chemistry", "Chikungunya virus", "Clinic", "Clinical", "Cold Chains", "Collaborations", "Communities", "Computational Biology", "Coronavirus", "Coupling", "Dangerousness", "Data", "Development", "Disease Outbreaks", "Drug Controls", "Drug Design", "Drug Formulations", "Drug Kinetics", "Drug Targeting", "Drug resistance", "Ebola virus", "Enzymatic Biochemistry", "Epidemic", "Event", "FDA approved", "Family", "Fertilization", "Filovirus", "Flavivirus", "Future", "Genomics", "Goals", "HIV/HCV", "Home", "Human", "Incentives", "Industrialization", "Industry", "Infection", "Influenza", "Influenza A Virus H1N1 Subtype", "Influenza A Virus H7N9 Subtype", "Interdisciplinary Study", "Investments", "Lead", "Leadership", "Lentivirus", "Methods", "Middle East Respiratory Syndrome Coronavirus", "Morbidity - disease rate", "Norovirus", "Oral", "Outpatients", "Peptide Hydrolases", "Persons", "Pharmaceutical Chemistry", "Pharmaceutical Preparations", "Pharmacologic Substance", "Pharmacology", "Planet Earth", "Population", "Prior Therapy", "Private Sector", "RNA Viruses", "Reagent", "Records", "Research", "Research Project Grants", "Risk", "SARS coronavirus", "Science", "Structure", "Techniques", "Testing", "Therapeutic", "Toxic effect", "Training", "United States", "Validation", "Viral", "Viral Proteins", "Virus", "Vulnerable Populations", "Zika Virus", "Zoonoses", "base", "clinical candidate", "coronavirus antiviral", "crowdsourcing", "design", "disorder control", "drug action", "drug candidate", "drug development", "drug discovery", "druggable target", "enzootic", "experience", "global health", "health economics", "helicase", "high risk", "high throughput screening", "human morbidity", "human mortality", "in vivo", "industry partner", "inhibitor/antagonist", "innovation", "innovative technologies", "medical countermeasure", "member", "mortality", "multidisciplinary", "novel", "nucleoside inhibitor", "open data", "pandemic disease", "portability", "preclinical development", "product development", "programs", "public-private partnership", "remdesivir", "replicase", "response", "small molecule libraries", "structural biology", "therapy development", "vi" ], "approved": true } }, { "type": "Grant", "id": "8724", "attributes": { "award_id": "3UM1AI068614-15S2", "title": "CoVPN 3005 - Efficacy, Immunogenicity, and Safety of SARS-CoV-2 Recombinant Protein Vaccine with Adjuvant in Adults 18 Years of Age and Older", "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": 6245, "first_name": "Philip O.", "last_name": "Renzullo", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2021-09-17", "end_date": "2022-11-30", "award_amount": 61429109, "principal_investigator": { "id": 6246, "first_name": "Dan H.", "last_name": "Barouch", "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": [ { "id": 6247, "first_name": "Lawrence", "last_name": "Corey", "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 } ] }, { "id": 6248, "first_name": "Glenda E", "last_name": "Gray", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, { "id": 6249, "first_name": "GEORGIA Doris", "last_name": "TOMARAS", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "awardee_organization": { "id": 757, "ror": "", "name": "FRED HUTCHINSON CANCER RESEARCH CENTER", "address": "", "city": "", "state": "WA", "zip": "", "country": "United States", "approved": true }, "abstract": "FOA: PA-20-272: Administrative Supplements to Existing NIH Grants and Cooperative Agreements Activity Code/Award: UM1/A1068614-15 (parent award) ------------------------------------------------------------------------------------ Project Abstract This proposal outlines the scientific agenda for the COVID-19 Prevention Network (CoVPN) Vaccines Leadership Operations Center (LOC) for implementation of the COVID-19 vaccine efficacy trial entitled “A parallel-group, Phase III, multi-stage, modified double-blind, multi-armed study to assess the efficacy, safety, and immunogenicity of two SARS-CoV-2 Adjuvanted Recombinant Protein Vaccines (monovalent and bivalent) for prevention against COVID-19 in adults 18 years of age and older.” With the global COVID-19 pandemic, we recognize a significant need for vaccines that modify COVID-19 in SARS-CoV-2 infected individuals. Addressing this gap, the National Institutes of Health (NIH) led rapid constitution of the CoVPN, partnering 5 NIH supported clinical trial networks, to create an enhanced network of physician-scientists at 145 United States (US) and 71 international clinical trial sites in 17 countries dedicated to developing globally effective vaccines for SARS-CoV-2. Due to its extensive experience implementing global HIV vaccine trials over the last 20 years, the HIV Vaccine Trials Network (HVTN) LOC was selected as the LOC for CoVPN vaccine trials. This Phase 3, multi-stage, modified double-blind, placebo-controlled, multi-armed study will test the efficacy, safety and immunogenicity of Sanofi-Pasteur SARS-CoV2 prefusion Spike delta TM with AS03 adjuvant, monovalent D614 (monovalent vaccine) & SARS-CoV2 prefusion Spike delta TM with AS03 adjuvant, bivalent D614/B.1.351 (bivalent vaccine), to modify COVID-19 disease in adults 18 years of age and older. Participants will be recruited from clinical trial sites across the US and globally using data analytics to target high risk individuals with a diverse racial and ethnic profile. Participants will receive symptomatic screening for SARS-CoV-2 infection, and if they become infected will be monitored with frequent clinical check-ins and remote monitoring of vital signs. Infected individuals who progress to moderate-severe COVID-19 will be referred for hospitalization. All trial endpoint assays will be done using qualified and validated assays for diagnosis and immune monitoring. Specific aims of this study are to assess the clinical efficacy of the investigational CoV2 preS dTM recombinant protein adjuvanted with AS03 – both monovalent and bivalent (“study vaccines”) in naïve adults for the prevention of symptomatic COVID-19 occurring > 14 days after the second injection; to assess the safety of the study vaccines compared to placebo throughout the study; to assess, in participants who are SARS-CoV-2 naïve, the clinical efficacy of the CoV2 preS dTM-AS03 vaccines for prevention of the following occurring > 14 days after the second injection: prevention of SARS-CoV-2 infection, prevention of severe COVID-19; to describe the frequency & spectrum of disease in episodes of symptomatic COVID-19 in SARS-CoV-2 non-naïve adults in each study group. This efficacy trial will tell us much about the ability of two recombinant vaccines, targeting two of the most common SARS-CoV-2 variants, to induce strong adaptive protective responses. After the Novavax vaccine, this is the second large scale recombinant protein vaccine to be tested for efficacy and it is the first trial to use a bivalent vaccine including the B.1.351 variant of concern. If successful, this will be an important vaccine that can be scaled up rapidly and deployed throughout the world. The results of this trial will be used to assess registration of this vaccine product and will also provide crucial information to inform future generations of COVID-19 vaccines.", "keywords": [ "18 year old", "2019-nCoV", "Address", "Adjuvant", "Administrative Supplement", "Adult", "Antigens", "Award", "Biological Assay", "Biometry", "COVID-19", "COVID-19 Prevention Network", "COVID-19 outbreak", "COVID-19 pandemic", "COVID-19 screening", "COVID-19 severity", "COVID-19 vaccine", "Cellular Assay", "Clinical", "Clinical Trials", "Clinical Trials Network", "Code", "Cohort Studies", "Communicable Diseases", "Constitution", "Coronavirus", "Country", "Data Analytics", "Development", "Diagnosis", "Disease", "Double-Blind Method", "End Point Assay", "Eye", "Frequencies", "Future Generations", "Goals", "Grant", "HIV Vaccine Trials Network", "HIV vaccine", "Health", "Hospitalization", "Immune", "Immune response", "Immunity", "Immunologic Monitoring", "Immunology", "Individual", "Infection Control", "Infection prevention", "Injections", "International", "Investigation", "Knowledge", "Laboratories", "Lead", "Leadership", "Malaria", "Mediating", "Monitor", "Morbidity - disease rate", "Parents", "Participant", "Persons", "Phase", "Physicians", "Placebos", "Population", "Preparation", "Prevention", "Protocols documentation", "Quality Control", "Randomized Clinical Trials", "Recombinant Proteins", "Recombinant Vaccines", "Research Methodology", "Risk", "SARS-CoV-2 B.1.351", "SARS-CoV-2 infection", "SARS-CoV-2 variant", "Safety", "Sampling", "Scientist", "Serology test", "Site", "System", "Testing", "Typhoid Fever", "U-Series Cooperative Agreements", "United States", "United States National Institutes of Health", "Vaccines", "Validation", "clinical efficacy", "clinical trial analysis", "design", "efficacy study", "efficacy testing", "efficacy trial", "experience", "high risk", "immune function", "immunogenicity", "improved", "mortality", "operation", "prevent", "programs", "quality assurance", "racial and ethnic", "racial diversity", "recruit", "remote monitoring", "response", "safety study", "scale up", "severe COVID-19", "symptomatic COVID-19", "vaccine trial", "variants of concern" ], "approved": true } }, { "type": "Grant", "id": "6770", "attributes": { "award_id": "3UM1AI068614-17S1", "title": "CoVPN 3008 - Multi-Center, Randomized, Efficacy Study of COVID-19 mRNA Vaccine in Regions with SARS-CoV-2 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": 6245, "first_name": "Philip O.", "last_name": "Renzullo", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2006-06-29", "end_date": "2027-11-30", "award_amount": 55953346, "principal_investigator": { "id": 6246, "first_name": "Dan H.", "last_name": "Barouch", "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": [ { "id": 6247, "first_name": "Lawrence", "last_name": "Corey", "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 } ] }, { "id": 6248, "first_name": "Glenda E", "last_name": "Gray", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, { "id": 6249, "first_name": "GEORGIA Doris", "last_name": "TOMARAS", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "awardee_organization": { "id": 758, "ror": "https://ror.org/007ps6h72", "name": "Fred Hutchinson Cancer Center", "address": "", "city": "", "state": "WA", "zip": "", "country": "United States", "approved": true }, "abstract": "FOA: PA-20-272: Administrative Supplements to Existing NIH Grants and Cooperative Agreements Activity Code/Award: UM1/A1068614-15 (parent award) ------------------------------------------------------------------------------------ Project Abstract This proposal outlines the scientific agenda for the COVID-19 Prevention Network (CoVPN) Vaccines Leadership Operations Center (LOC) for implementation of the COVID-19 vaccine efficacy trial entitled “Multi-Center, Randomized, Efficacy Study of COVID-19 mRNA Vaccine in Regions with SARS-CoV-2 Variants of Concern.” With the global COVID-19 pandemic, we recognize a significant need for vaccines that modify COVID-19 in SARS-CoV-2 infected individuals. Addressing this gap, the National Institutes of Health (NIH) led rapid constitution of the CoVPN, partnering 5 NIH supported clinical trial networks, to create an enhanced network of physician-scientists at 145 United States (US) and 71 international clinical trial sites in 17 countries dedicated to developing globally effective vaccines for SARS-CoV-2. Due to its extensive experience implementing global HIV vaccine trials over the last 20 years, the HIV Vaccine Trials Network (HVTN) LOC was selected as the LOC for CoVPN vaccine trials. This Phase 3, observer-blinded, placebo-controlled, crossover-vaccination study will test the efficacy of the COVID-19 ancestral strain mRNA vaccine in preventing COVID-19 disease regardless of severity, and preventing COVID-19 severe disease in people who are at risk for severe COVID-19 in areas of the world where the prevalence of the SARS-CoV-2 1.351 strain is substantial. The trial has been designed to provide as rapid assessment of efficacy as possible in regions of the world where local access to effective vaccines are limited. Subjects will be randomized in a 1:1 ratio to receive immediate or deferred vaccine. The blinded cross-over is expected to take place when vaccine benefit is declared based on at least 50 primary COVID-19 endpoints, anticipated to be accrued approximately 3 months post-trial start. All trial endpoint assays will be done using qualified and validated assays for diagnosis and immune monitoring. Specific aims of this study are to demonstrate efficacy of COVID-19 mRNA (Moderna mRNA-1273) vaccine to prevent virologically-confirmed symptomatic COVID-19 starting 14 days after dose 2 in adults who are at risk of severe COVID-19; to assess vaccine efficacy of COVID-19 mRNA vaccine to prevent severe COVID-19 starting 14 days after dose 2 in adults who are at risk of severe COVID-19; and to assess safety and tolerability of COVID-19 mRNA vaccine in adults who are at risk of severe COVID-19. This efficacy trial will tell us much about ability of an mRNA vaccine against the ancestral Wuhan strain of SARS- CoV-2 to protect individuals exposed to divergent strains, and in particular 1.351 first predominant in South Africa. In addition, it will improve our understanding of the dynamics and duration of these immune responses and will inform rational design and testing of preventive and therapeutic monoclonal antibody interventions in parts of the world where alternative strains continue to proliferate. Lastly, the results of this trial will be used to assess registration of this vaccine product as well as to modify future COVID-19 vaccine trials planned over the next 12 months.", "keywords": [ "2019-nCoV", "Address", "Administrative Supplement", "Adult", "Africa South of the Sahara", "Area", "Award", "Biological Assay", "Biometry", "Blinded", "COVID-19", "COVID-19 Prevention Network", "COVID-19 outbreak", "COVID-19 pandemic", "COVID-19 prevention", "COVID-19 severity", "COVID-19 vaccine", "Cellular Assay", "Clinical", "Clinical Trials", "Clinical Trials Network", "Code", "Cohort Studies", "Communicable Diseases", "Constitution", "Coronavirus", "Country", "Development", "Diagnosis", "Disease", "Dose", "End Point Assay", "Exposure to", "Eye", "Future", "Goals", "Grant", "HIV Vaccine Trials Network", "HIV vaccine", "Health", "High Prevalence", "Immune", "Immune response", "Immunity", "Immunologic Monitoring", "Immunology", "Individual", "Infection Control", "International", "Intervention", "Knowledge", "Laboratories", "Lead", "Leadership", "Malaria", "Mediating", "Messenger RNA", "Moderna COVID-19 vaccine", "Morbidity - disease rate", "Parents", "Persons", "Phase", "Physicians", "Placebo Control", "Population", "Preparation", "Prevalence", "Prevention", "Preventive", "Proliferating", "Protocols documentation", "Quality Control", "RNA vaccine", "Randomized", "Randomized Clinical Trials", "Research Methodology", "Risk", "SARS-CoV-2 B.1.351", "SARS-CoV-2 exposure", "SARS-CoV-2 infection", "SARS-CoV-2 variant", "Safety", "Sampling", "Scientist", "Serology test", "Severities", "Site", "South Africa", "System", "Testing", "Therapeutic Monoclonal Antibodies", "Typhoid Fever", "U-Series Cooperative Agreements", "United States", "United States National Institutes of Health", "Vaccines", "Validation", "base", "clinical trial analysis", "design", "efficacy evaluation", "efficacy study", "efficacy testing", "efficacy trial", "experience", "immune function", "improved", "mortality", "operation", "prevent", "programs", "quality assurance", "response", "severe COVID-19", "symptomatic COVID-19", "vaccine efficacy", "vaccine trial", "variants of concern", "virology" ], "approved": true } }, { "type": "Grant", "id": "9828", "attributes": { "award_id": "75N91019D00024-P00002-759102100001-1", "title": "Frederick National Laboratory for Cancer Research (FNLCR) Center for SARS-CoV-2 Serological Sciences", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Cancer Institute (NCI)" ], "program_reference_codes": [], "program_officials": [], "start_date": "2021-02-11", "end_date": "2026-02-10", "award_amount": 51911972, "principal_investigator": { "id": 23964, "first_name": "ETHAN", "last_name": "DMITROVSKY", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [ { "id": 1610, "ror": "", "name": "LEIDOS BIOMEDICAL RESEARCH, INC.", "address": "", "city": "", "state": "MD", "zip": "", "country": "United States", "approved": true } ] }, "other_investigators": [], "awardee_organization": { "id": 1610, "ror": "", "name": "LEIDOS BIOMEDICAL RESEARCH, INC.", "address": "", "city": "", "state": "MD", "zip": "", "country": "United States", "approved": true }, "abstract": "The purpose of the National Cancer Institute’s SARS-CoV-2 Serological Sciences Network (SeroNet) is to study the immune response to COVID-19 by developing and deploying serological assays of the highest specificity and sensitivity, expanding the national testing capacity for SARS-CoV-2 antibodies, and conducting research to develop understanding of immune responses to SARS-CoV-2. The FNLCR Center for SARS-CoV-2 Serological Sciences (the Center) is comprised of (1) Frederick National Laboratory (FNL) Serology Lab, (2) SARS-CoV-2 Serology Capacity Building Centers (CBCs), and (3) a Coordination Center that coordinates the activities of all SeroNet components. The Center’s priority for the FNL Serology Lab will be for the development and validation of serological antibody assays, including ELISAs, point of care lateral flow tests, and virus neutralization assays. The Center will also develop and disseminate the National SARS-CoV-2 serology standard that includes positive and negative controls along with proficiency panel samples. The Center will also implement laboratory based serology assays and increase assay throughput capabilities within the FNLCR Vaccine, Immunity and Cancer (VIC) Program and the CBCs for use in viral immunology studies to understand longitudinal responses to natural infection or vaccination and to determine correlates of protection against infection in sero-epidemiology studies with the NIH/NCI and outside community. The Center’s CBCs will build serological testing capacity by expanding testing to ~10K samples/week and conducting research in the natural history of infection or following vaccination to identify determinants of the immune response to SARS-CoV-2. The CBCs will also develop new assays as needed for deeper characterization of immune responses to the virus, vaccines, and correlates of protection. This may include development of assays for different functional aspects of the humoral responses, such as pseudovirus neutralization assays, determinants of antibody response and other relevant disease biomarkers. The data from these inter-collaborative studies, the U54 Serological Sciences Centers of Excellence, and U01 Research Projects in SARS-CoV-2 will be made available to the community through the Coordination Center within the Center.", "keywords": [ "2019-nCoV", "Antibody Response", "Biological Assay", "Biological Markers", "COVID-19", "COVID-19 vaccination", "COVID-19 vaccine", "Communities", "Data", "Development", "Disease", "Enzyme-Linked Immunosorbent Assay", "Immune response", "Immunity", "Immunology", "Infection", "Laboratories", "Malignant Neoplasms", "NCI Center for Cancer Research", "National Cancer Institute", "Natural History", "Research", "Research Project Grants", "SARS-CoV-2 antibody", "Sampling", "Science", "Sensitivity and Specificity", "Serology", "Serology test", "Testing", "United States National Institutes of Health", "Vaccination", "Vaccine Research", "Vaccines", "Validation", "Viral", "Virus", "antibody test", "anticancer research", "assay development", "base", "epidemiology study", "lateral flow assay", "point of care", "programs", "response" ], "approved": true } }, { "type": "Grant", "id": "9099", "attributes": { "award_id": "3OT2HL156812-01S1", "title": "ACTIV Integration of Host-targeting Therapies for COVID-19 Administrative Coordinating Center", "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": 7612, "first_name": "ANTONELLO", "last_name": "PUNTURIERI", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2020-06-15", "end_date": "2021-05-31", "award_amount": 50000000, "principal_investigator": { "id": 7614, "first_name": "Sonia M", "last_name": "Thomas", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [ { "id": 809, "ror": "", "name": "RESEARCH TRIANGLE INSTITUTE", "address": "", "city": "", "state": "NC", "zip": "", "country": "United States", "approved": true } ] }, "other_investigators": [], "awardee_organization": { "id": 809, "ror": "", "name": "RESEARCH TRIANGLE INSTITUTE", "address": "", "city": "", "state": "NC", "zip": "", "country": "United States", "approved": true }, "abstract": "RTI International is pleased to provide this application as requested by the Research Opportunities Announcement OTA-20-011 ACTIV Integration of Host-targeting Therapies for COVID-19 for the role of Administrative Coordinating Center (ACC). The title of our application is ACTIV Integration of Host-targeting Therapies for COVID-19 Administrative Coordinating Center. The Integration of Host-targeting Therapies for COVID-19 Program aims to identify COVID-19 interventions relevant to heart, lung, blood, and cardiovascular outcomes that contribute to the scientific knowledge base are likely to inform clinical practice. This Program will rapidly and efficiently conduct adaptive platform trials via a coordinated effort of Data Coordinating Centers and clinical sites from existing Clinical Study Networks. The ACC is a critical component of the Program. We will coordinate with NHLBI to ensure collaboration among networks including the use of standardized approaches in clinical trial design and conduct, data collection and validation, and statistical analysis such that studies are launched, implemented and analyzed swiftly; and study findings are scientifically sound and meet regulatory needs for medical therapy development. As the ACC, we will also serve the vital role of facilitating communication and information sharing among all relevant stake holders and helping NHLBI in tracking study-specific and Program-wide milestones. Sonia Thomas, DrPH, will lead the ACC as Principal Investigator. She is an experienced CC PI and statistician with 25 years of experience in the design, implementation, and analysis of multicenter NIHand industry-sponsored Phase 2-4 clinical trials of drugs, biologics, devices, surgical and behavioral interventions in more than a dozen therapeutic indications. Dr. Thomas will be supported by Tracy Nolen, DrPH as Alternate PI, an experienced Consortium and CC PI and clinical trial statistician, and subject matter experts Steve Nissen, MD, Cleveland Clinical Chief Academic Officer, Heart and Vascular Institute, Shannon Carson, MD, Univ. of North Carolina Chief of Pulmonary and Critical Care Medicine, and Anastasia Ivanova, PhD, Univ. of North Carolina Professor of Biostatistics Under Dr Thomas’s direction, our team will lead, support, and collaborate with Program Networks through organization into 6 ACC Cores: Program Operations, Scientific Leadership and Prioritization, Informatics, Data Standards, Study Design, Implementation, & Analysis, and Regulatory and QA. We have identified milestones for the essential activities of the ACC within each of these 6 Cores with a detailed focus on the activities in the first 6 months as activities completed during this time are most important for ensuring the coordinated, expedited and efficient launch of this Program. Dr. Thomas, our subject matter experts, senior statistical scientists, and many of the core leads have substantial experience with NHLBI and thus understand the needs and priorities of the Institute and will use this knowledge to better collaborate with NHLBI and further speed up the launch of this Program. We are willing to collaborate with all involved entities as part of the overarching trans-NIH ACTIV Program as it evolves. We recognize and anticipate that swift adaptation will be required to rapidly respond to the urgent clinical research needs to address the COVID-19 pandemic. RTI is uniquely and substantially qualified for the ACC. We will use our team’s broad experience from many complex coordinating center projects to anticipate the needs for this Program and “hit the ground running”. Proven informatics technology in use by existing NIH programs will be swiftly modified by our analysts for speedy deployment of communications platforms. Our organizational size and flexibility will allow us to ramp up quickly and modify personnel resources flexibly. Lastly, RTI has a proven track record of successful collaborations with other coordinating centers on complex programs, yet as we are not directly involved with any Networks for consideration to be NHLBI COVID-19 trials sites, we provide independence and objectivity to the Program.", "keywords": [ "Address", "Adoption", "Area", "Behavior Therapy", "Biological", "Biometry", "Blood", "COVID-19", "COVID-19 pandemic", "Cardiovascular system", "Clinic", "Clinical", "Clinical Research", "Clinical Trials", "Clinical Trials Design", "Clinical Trials Network", "Collaborations", "Communication", "Complex", "Consensus", "Critical Care", "Data Collection", "Data Coordinating Center", "Development", "Devices", "Doctor of Philosophy", "Documentation", "Effectiveness", "Ensure", "Funding", "Goals", "Heart", "Human Resources", "Image", "Industry", "Informatics", "Information Dissemination", "Infrastructure", "Institutes", "International", "Intervention", "Knowledge", "Lead", "Leadership", "Lung", "Medical", "Medicine", "National Heart Lung and Blood Institute", "North Carolina", "Online Systems", "Operative Surgical Procedures", "Outcome", "Pharmaceutical Preparations", "Phase", "Principal Investigator", "Process", "Ramp", "Reporting", "Research", "Research Design", "Resources", "Role", "Running", "Scientist", "Site", "Speed", "Standardization", "Statistical Data Interpretation", "Technology", "Therapeutic", "Time", "United States National Institutes of Health", "Universities", "Validation", "clinical practice", "clinical research site", "data harmonization", "data quality", "data standards", "design", "experience", "flexibility", "informatics tool", "insight", "knowledge base", "operation", "professor", "programs", "protocol development", "sound", "targeted treatment", "therapy development" ], "approved": true } }, { "type": "Grant", "id": "10223", "attributes": { "award_id": "75N93021D00035-0-759302200001-1", "title": "Clinical Trial Management Support Services for ACTIV-2", "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": "2022-05-06", "end_date": "2022-11-05", "award_amount": 48582260, "principal_investigator": { "id": 26179, "first_name": "MARY", "last_name": "GLESSNER", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [], "awardee_organization": { "id": 1807, "ror": "", "name": "PPD, INC.", "address": "", "city": "", "state": "NC", "zip": "", "country": "United States", "approved": true }, "abstract": "Comprehensive and Rapid Response for NIAID Research Program (CARRRP): Provide the capacity and capability for a broad range of services necessary to support and conduct biomedical research in support of the NIAID mission and the management of activities specified under the Statement of Work and associated Task Orders. The purpose of this task order is to acquire comprehensive/full clinical trial management support services to the ongoing Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV-2) clinical trial. The objective of ACTIV-2 is to evaluate the safety and efficacy of investigational agents for the treatment of symptomatic non-hospitalized adults with COVID-19.", "keywords": [ "Adult", "Biomedical Research", "COVID-19", "COVID-19 therapeutics", "Clinical Trials", "Investigation", "Mission", "National Institute of Allergy and Infectious Disease", "Research", "Safety", "Services", "Specific qualifier value", "Therapeutic Intervention", "Vaccine Clinical Trial", "Work", "programs", "response", "symptom treatment", "therapeutic vaccine" ], "approved": true } }, { "type": "Grant", "id": "9083", "attributes": { "award_id": "3U54HL143541-02S1", "title": "Center for Advancing Point of Care Technologies (CAPCaT) Administrative Supplement", "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": 24882, "first_name": "JUE", "last_name": "CHEN", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2020-06-01", "end_date": "2022-05-31", "award_amount": 41809845, "principal_investigator": { "id": 24883, "first_name": "BRYAN O", "last_name": "BUCHHOLZ", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [ { "id": 790, "ror": "", "name": "UNIV OF MASSACHUSETTS MED SCH WORCESTER", "address": "", "city": "", "state": "MA", "zip": "", "country": "United States", "approved": true } ] }, "other_investigators": [ { "id": 24884, "first_name": "David D.", "last_name": "McManus", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "awardee_organization": { "id": 790, "ror": "", "name": "UNIV OF MASSACHUSETTS MED SCH WORCESTER", "address": "", "city": "", "state": "MA", "zip": "", "country": "United States", "approved": true }, "abstract": "RESEARCH SUMMARY/ABSTRACT The goal of this initiative is to fast-track the implementation of carefully selected CAPCaT-supported projects that can help address the urgent healthcare issues created by the COVID-19 pandemic. The extent and urgency of the situation requires an aggressive approach to accelerate the delivery of solutions to address the immediate needs. The proposed approach augments the strong technical, clinical and commercialization expertise of CAPCaT to get needed solutions into practice within weeks to months. The Center for Advancing Point of Care Technologies (CAPCaT) in Heart, Lung, Blood, and Sleep Diseases is an offshoot of a highly successful medical product incubator, the Massachusetts Medical Device Development Center (M2D2) at the University of Massachusetts Lowell and Medical School campuses. The founding goal of M2D2 was to accelerate the development of medical devices, combining the engineering and business expertise of UMass Lowell (UML) with the clinical expertise of UMass Medical School (UMMS) in Worcester. Expanding upon the vision and success of M2D2, the goal of CAPCaT is to support projects to develop and optimize novel point of care technologies (POCT) to improve the diagnosis and management of heart, lung, blood, and sleep diseases. We have focused on these diseases because of the significant morbidity, mortality, and cost associated with these diseases. Combined, these diseases account for 41% of deaths in the US and lead to over $400B in direct health care expenses plus lost income to affected patients and caregivers. UMass has an established track record of clinical expertise and technology development in the HLBS diseases. CAPCaT funds projects that are in the later stages of POCT development, with a focus on the clinical validation of those devices. CAPCaT, along with M2D2, has a network of industry partners and funders to support the development and commercialization of promising technologies. Among our industry partners are Johnson & Johnson, Boston Scientific, Amgen, and Hologic. CAPCaT is one of four Point of Care Technology Research Network (POCTRN) Centers (Emory/GA Tech, Northwestern, and Johns Hopkins University house the others). CAPCaT has worked with the other POCTRN Centers and its Coordinating Center (CIMIT-Mass General Hospital) and our scientific and program officers at NHLBI and NIBIB to review the situation and to understand unmet needs and resources accessible by the network that can make a difference.", "keywords": [ "Address", "Administrative Supplement", "Affect", "Award", "Biotechnology", "Boston", "Businesses", "COVID-19", "COVID-19 pandemic", "Care Technology Points", "Caregivers", "Cessation of life", "Clinic", "Clinical", "Collaborations", "Communities", "Country", "Development", "Device or Instrument Development", "Devices", "Diagnosis", "Disease", "Engineering", "Feedback", "Funding", "General Hospitals", "Goals", "Health", "Healthcare", "Heart Diseases", "Hematological Disease", "Income", "Incubators", "Individual", "Knowledge", "Lead", "Legal", "Lung diseases", "Massachusetts", "Medical", "Medical Device", "Mentors", "Modeling", "Monitor", "Morbidity - disease rate", "National Heart Lung and Blood Institute", "National Institute of Biomedical Imaging and Bioengineering", "Needs Assessment", "Patients", "Process", "Provider", "Research", "Resources", "Safety", "Services", "Sleep Disorders", "Technology", "United States National Institutes of Health", "Universities", "Validation", "Vision", "Work", "base", "clinical development", "commercialization", "cost", "design", "improved", "industry partner", "interest", "invention", "medical schools", "mortality", "novel", "product development", "professional partner", "programs", "prototype", "research clinical testing", "response", "success", "technology development", "tool", "usability" ], "approved": true } }, { "type": "Grant", "id": "7684", "attributes": { "award_id": "75N91019D00024-0-759102000010-1", "title": "The Adaptive COVID-19 Treatment Trial (ACTT)", "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": "2020-04-03", "end_date": "2025-04-02", "award_amount": 40199082, "principal_investigator": { "id": 23486, "first_name": "BETH", "last_name": "BASELER", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [ { "id": 1610, "ror": "", "name": "LEIDOS BIOMEDICAL RESEARCH, INC.", "address": "", "city": "", "state": "MD", "zip": "", "country": "United States", "approved": true } ] }, "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 randomized, controlled clinical trials to evaluate the safety and efficacy of investigational antiviral drugs against COVID-19.", "keywords": [ "Antiviral Agents", "COVID-19", "Investigation", "Randomized Controlled Clinical Trials", "Safety", "therapeutic evaluation", "treatment trial" ], "approved": true } }, { "type": "Grant", "id": "8138", "attributes": { "award_id": "3U24TR001608-05S4", "title": "ACTIV 6", "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": 23494, "first_name": "Sarah", "last_name": "Dunsmore", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2021-04-17", "end_date": "2023-06-30", "award_amount": 38494599, "principal_investigator": { "id": 21094, "first_name": "DANIEL K.", "last_name": "BENJAMIN", "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": 23026, "first_name": "Susanna", "last_name": "Naggie", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, { "id": 24010, "first_name": "Adrian", "last_name": "Hernandez", "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": "Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a novel betacoronavirus that first emerged in December 2019 and has since caused a global pandemic unseen in almost a century with respect to the number of cases and overall mortality. Over 2020, advances were made for treatment of COVID-19 and several vaccinations have received emergency use authorization for prevention of SARS-CoV-2 infections. However, the pandemic continues to evolve with new variants and surges of infections in different regions of the world, requiring an ongoing evidence-generating platform, in particular for the oral treatment of COVID-19 infection in the outpatient setting. To address this unmet need the Duke Clinical Research Institute, Vanderbilt University Medical Center and partners are coming together to coordinate ACTIV-6 as a platform with a master clinical trial protocol that can serve as an evidence generating system for prioritized drugs repurposed from other indications with an established safety record and preliminary evidence of clinical efficacy for the treatment of COVID-19.", "keywords": [ "2019-nCoV", "Academic Medical Centers", "Accident and Emergency department", "Address", "Affect", "Ambulatory Care", "Benefits and Risks", "COVID-19", "COVID-19 diagnosis", "COVID-19 pandemic", "COVID-19 treatment", "Clinical", "Clinical Data", "Clinical Investigator", "Clinical Research", "Clinical Trials", "Clinical trial protocol document", "Collaborations", "Data", "Data Coordinating Center", "Data Science", "Data Scientist", "Early treatment", "Enrollment", "Ensure", "FDA Emergency Use Authorization", "Generations", "Geographic Locations", "Goals", "Healthcare Systems", "Hospitals", "Hybrids", "Infection", "Informatics", "International", "Leadership", "Link", "Methodology", "Methods", "Oral", "Outpatients", "Participant", "Patients", "Pragmatic clinical trial", "Prevention", "Principal Investigator", "Protocols documentation", "Research", "Research Institute", "Research Personnel", "SARS-CoV-2 infection", "Safety", "Site", "Special Population", "System", "United States", "Vaccination", "Variant", "betacoronavirus", "clinical efficacy", "cohort", "data management", "design", "drug repurposing", "experience", "innovation", "mortality", "non-drug", "novel", "operation", "pandemic disease", "patient engagement", "response", "statistics" ], "approved": true } }, { "type": "Grant", "id": "9104", "attributes": { "award_id": "3OT2HL156812-01S8", "title": "ACTIV Integration of Host-targeting Therapies for COVID-19 Administrative Coordinating Center", "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": 7612, "first_name": "ANTONELLO", "last_name": "PUNTURIERI", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2020-06-15", "end_date": "2022-05-31", "award_amount": 37709210, "principal_investigator": { "id": 7614, "first_name": "Sonia M", "last_name": "Thomas", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [ { "id": 809, "ror": "", "name": "RESEARCH TRIANGLE INSTITUTE", "address": "", "city": "", "state": "NC", "zip": "", "country": "United States", "approved": true } ] }, "other_investigators": [], "awardee_organization": { "id": 809, "ror": "", "name": "RESEARCH TRIANGLE INSTITUTE", "address": "", "city": "", "state": "NC", "zip": "", "country": "United States", "approved": true }, "abstract": null, "keywords": [], "approved": true } } ], "meta": { "pagination": { "page": 3, "pages": 1392, "count": 13920 } } }