Grant List
Represents Grant table in the DB
GET /v1/grants?page%5Bnumber%5D=1405&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=1424&sort=award_amount", "next": "https://cic-apps.datascience.columbia.edu/v1/grants?page%5Bnumber%5D=1406&sort=award_amount", "prev": "https://cic-apps.datascience.columbia.edu/v1/grants?page%5Bnumber%5D=1404&sort=award_amount" }, "data": [ { "type": "Grant", "id": "14166", "attributes": { "award_id": "75N95021D00029-0-759502300001-1", "title": "SECURE PLATFORMS SUPPORT FOR THE N3C DATA ENCLAVE (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": [], "start_date": "2022-12-18", "end_date": "2023-04-17", "award_amount": 6361494, "principal_investigator": { "id": 26481, "first_name": "BRIAN", "last_name": "ZAVERTNIK", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [], "awardee_organization": { "id": 1737, "ror": "", "name": "PALANTIR TECHNOLOGIES, INC.", "address": "", "city": "", "state": "CO", "zip": "", "country": "United States", "approved": true }, "abstract": "National COVID-19 Cohort Collaborative (N3C): The National COVID-19 Cohort Collaborative (N3C) sponsors the NIH COVID-19 Data Enclave, https://covid.cd2h.org/, one of the largest data enclaves in the world supporting COVID-19 research. N3C is a partnership among the NCATS-supported Clinical and Translational Science Awards (CTSA) Program hubs, the National Center for Data to Health (CD2H), and the NIGMS-supported Institutional Development Award Networks for Clinical and Translational Research (IDeA-CTR), with overall stewardship by NCATS. The N3C Data Enclave is a secure platform storing harmonized clinical data provided by more than 60 contributing members. The Enclave hosts over 670 million clinical observations on over 6.8 million persons, including over 2.2 million COVID cases, amounting to more than 7.8 billion rows of data. To protect privacy, this data consists only of limited data sets, de-identified data sets, and synthetic data sets; there is no personally identifiable information kept in the Enclave. The Enclave resides in the NCATS Secure Scientific Platforms Environment. The Environment is a specialized cloud-based data aggregation and analytics enclave that can integrate, manage, secure, and analyze any kind of scientific data, and provide secure, controlled access to internal and external collaborators. Within the Environment, multiple NIH ICs, Federal agencies, and Federal task forces integrate, manage, secure, and analyze all types of scientific data using dedicated platforms, and, equally importantly, make that data available in specific and controlled collaborations with each other and with external collaborators.", "keywords": [], "approved": true } }, { "type": "Grant", "id": "7000", "attributes": { "award_id": "3UM1AI148372-01S1", "title": "Cincinnati Children's Hospital Medical Center Vaccine and Treatment Evaluation Units (UM1 Clinical Trial Required)", "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": 21800, "first_name": "SEEMA UMESH", "last_name": "Nayak", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2020-08-24", "end_date": "2022-11-30", "award_amount": 6390081, "principal_investigator": { "id": 21801, "first_name": "Robert Wilson", "last_name": "Frenck", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [ { "id": 897, "ror": "", "name": "CINCINNATI CHILDRENS HOSP MED CTR", "address": "", "city": "", "state": "OH", "zip": "", "country": "United States", "approved": true } ] }, "other_investigators": [], "awardee_organization": { "id": 897, "ror": "", "name": "CINCINNATI CHILDRENS HOSP MED CTR", "address": "", "city": "", "state": "OH", "zip": "", "country": "United States", "approved": true }, "abstract": "Throughout history, infectious diseases have been, and continue to be, a leading cause of morbidity and mortality throughout the world. While all ages are affected by infectious diseases, the ends of the spectrum of life (young children and elderly) are particularly vulnerable. Thus, the prevention and treatment of infectious diseases through the development of vaccines, therapeutics, devices and diagnostics is a critical global priority. As a VTEU for nearly 25 years, we have provided the scientific, clinical, administrative, and organizational structure to support implementation of clinical trials and studies for the Division of Microbiology and Infectious Diseases (DMID) including respiratory infections, enteric diseases, sexually transmitted infections and neglected tropical diseases. Also, we are recognized experts in the area of human challenge infection models (CHIMs) of enteric and respiratory pathogens. Additionally we repeatedly have demonstrated the ability to provide surge capacity to address infectious disease outbreaks as evidenced by our responses to the testing of H5N1 and novel H1N1 influenza vaccines (for which we received a personal letter from Dr Anthony Fauci). To further expand the capabilities of our Unit; we have added expertise in epidemiology and vaccine effectiveness. We consistently have met or exceed enrollment goals and routinely have over 90% of our subjects complete the study. We consistently have exceeded contractual obligations, including rapid recruitment of subjects spanning the age spectrum including pregnant women. We have provided outstanding leadership of multi-center studies and have been excellent collaborators on studies led by other VTEU sites. We have developed investigator initiated trials and have assisted in the development of trials initiated by DMID. We also have undertaken vaccine projects incorporating systems biology to more deeply understand correlates of vaccine-induced immunity. We are extremely excited to continue as a VTEU, collaborating with the IDCRC, the Leadership Group, NIAID, and other Infectious Diseases experts under this NIAID Cooperative Agreement.", "keywords": [ "Address", "Adolescent", "Adult", "Affect", "Age", "Applied Research", "Area", "Award", "Biological Assay", "Biological Response Modifier Therapy", "Budgets", "Child", "Clinical", "Clinical Research", "Clinical Trials", "Collaborations", "Communicable Diseases", "Consent Forms", "Data Analyses", "Development", "Devices", "Diagnostic", "Disease", "Disease Outbreaks", "Elderly", "Emerging Communicable Diseases", "Enrollment", "Ensure", "Enteral", "Epidemiology", "Evaluation", "Faculty", "Future", "Goals", "Group Structure", "Human", "Immunocompromised Host", "Infant", "Infection", "Influenza", "Influenza A Virus H1N1 Subtype", "Influenza A Virus H5N1 Subtype", "Intervention Trial", "Laboratories", "Leadership", "Letters", "Life", "Manuals", "Medical center", "Mentors", "Methods", "Microbiology", "Mission", "Modeling", "Modification", "Morbidity - disease rate", "Multicenter Studies", "National Institute of Allergy and Infectious Disease", "Norovirus", "Ohio", "Outpatients", "Participant", "Pediatric Hospitals", "Performance", "Phase", "Population", "Pregnant Women", "Preparation", "Prevention", "Preventive", "Prognostic Marker", "Protocols documentation", "Public Health", "Publications", "Quality Control", "Recording of previous events", "Research Design", "Research Personnel", "Respiratory Tract Infections", "Sexually Transmitted Diseases", "Shigella sonnei", "Site", "Systems Biology", "Technology", "Testing", "Therapeutic", "Training", "U-Series Cooperative Agreements", "United States National Institutes of Health", "Vaccines", "biodefense", "clinical implementation", "clinical research site", "data dissemination", "data tools", "design", "infectious disease treatment", "influenza virus vaccine", "innovation", "investigator-initiated trial", "medical specialties", "mortality", "neglected tropical diseases", "novel", "operation", "organizational structure", "pathogen", "predictive marker", "prevent", "recruit", "respiratory", "response", "trial design", "vaccine candidate", "vaccine development", "vaccine effectiveness", "vaccine trial", "vaccine-induced immunity" ], "approved": true } }, { "type": "Grant", "id": "9105", "attributes": { "award_id": "3OT2HL156812-01SB", "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": [ "NIH Office of the Director" ], "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": "2022-12-31", "award_amount": 6395703, "principal_investigator": { "id": 7613, "first_name": "Tracy L", "last_name": "Nolen", "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": [ { "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 } ] } ], "awardee_organization": { "id": 809, "ror": "", "name": "RESEARCH TRIANGLE INSTITUTE", "address": "", "city": "", "state": "NC", "zip": "", "country": "United States", "approved": true }, "abstract": null, "keywords": [], "approved": true } }, { "type": "Grant", "id": "9308", "attributes": { "award_id": "272201800013I-0-759302000006-1", "title": "Task V12: Clinical Sample Testing for SARS-CoV-2 Vaccine Candidates", "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": "2020-09-18", "end_date": "2022-09-17", "award_amount": 6398512, "principal_investigator": { "id": 24843, "first_name": "THOMAS", "last_name": "RUDGE", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [ { "id": 1789, "ror": "", "name": "BATTELLE CENTERS/PUB HLTH RES & EVALUATN", "address": "", "city": "", "state": "OH", "zip": "", "country": "United States", "approved": true } ] }, "other_investigators": [], "awardee_organization": { "id": 1789, "ror": "", "name": "BATTELLE CENTERS/PUB HLTH RES & EVALUATN", "address": "", "city": "", "state": "OH", "zip": "", "country": "United States", "approved": true }, "abstract": "The Evaluation and Testing Services (ETS) for Vaccines and Other Biologics for Infectious Diseases contract provides a variety of product development services from early feasibility studies through manufacture of Phase I/II material, including assay development; immunogenicity and efficacy testing; clinical and nonclinical sample testing; and safety and toxicity testing. These services will facilitate the development and introduction of new vaccines and biologics against potential agents of bioterrorism and emerging and re-emerging infectious diseases.", "keywords": [ "2019-nCoV", "Biological", "Bioterrorism", "COVID-19", "Clinical", "Communicable Diseases", "Contracts", "Development", "Emerging Communicable Diseases", "Feasibility Studies", "Phase", "Sampling", "Services", "Testing", "Toxicity Tests", "Vaccines", "assay development", "efficacy testing", "evaluation/testing", "immunogenicity", "novel coronavirus", "novel vaccines", "product development", "safety testing", "testing services", "vaccine candidate", "vaccine development" ], "approved": true } }, { "type": "Grant", "id": "6692", "attributes": { "award_id": "1P01AI165075-01", "title": "Broad neutralization of pandemic threat coronaviruses", "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": 22407, "first_name": "JENNIFER L.", "last_name": "Gordon", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2022-01-03", "end_date": "2024-12-31", "award_amount": 6423268, "principal_investigator": { "id": 22408, "first_name": "Paul D.", "last_name": "Bieniasz", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [ { "id": 763, "ror": "https://ror.org/0420db125", "name": "Rockefeller University", "address": "", "city": "", "state": "NY", "zip": "", "country": "United States", "approved": true } ] }, "other_investigators": [ { "id": 22409, "first_name": "Pamela J", "last_name": "Bjorkman", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [ { "id": 211, "ror": "https://ror.org/05dxps055", "name": "California Institute of Technology", "address": "", "city": "", "state": "CA", "zip": "", "country": "United States", "approved": true } ] }, { "id": 22410, "first_name": "Marina", "last_name": "Caskey", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, { "id": 22411, "first_name": "Theodora", "last_name": "Hatziioannou", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, { "id": 22412, "first_name": "Michel C", "last_name": "Nussenzweig", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, { "id": 22413, "first_name": "Charles M", "last_name": "Rice", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "awardee_organization": { "id": 763, "ror": "https://ror.org/0420db125", "name": "Rockefeller University", "address": "", "city": "", "state": "NY", "zip": "", "country": "United States", "approved": true }, "abstract": "ABSTRACT-OVERALL The recurrent emergence of coronaviruses from animal reservoirs, and the resulting COVID19 pandemic, necessitates the development of interventions that can target diverse pandemic-threat coronaviruses. Vaccines are among the most powerful means for mitigating viral epidemics but require significant breadth to maximize the probability of effectiveness against unknown viral threats. Currently, first generation vaccines are being deployed to combat SARS-CoV-2, but their effectiveness against emergent SARS-CoV-2 variants and, importantly, against other potential zoonotic coronaviruses is unknown. This program will focus on neutralizing antibodies as a demonstrated and key component of protective immune responses. The Program will improve preparedness against coronaviruses, employing a progressive multistep approach to increase the breadth of vaccine protection. A key component of the research will be to comprehend how neutralizing antibody responses, elicited in humans following natural infection or vaccination, target the SARS-CoV-2 envelope spike and how antibody evolution leads to increased potency and breadth. The identification and characterization of epitopes targeted by SARS-CoV-2 neutralizing antibodies, using multiple approaches, will guide the design of immunogens that aim to elicit neutralizing antibodies targeting as diverse a spectrum of coronaviruses as possible. Several immunogens and delivery strategies will be tested in mice and hamsters that will be challenged with authentic SARS-CoV-2 or a panoply of newly developed challenge models incorporating divergent coronavirus spike proteins. Antibodies elicited in these animals will be analyzed and compared with those found in SARS-CoV-2 immunized humans and immunogens progressively refined and down-selected with the goal of performing vaccine-challenge experiments in nonhuman primates with the most promising candidates. The expertise of each participating team is highly complementary and the program will capitalize and build on the already existing scientific synergy to ensure the efficient and timely completion of the goals.", "keywords": [ "2019-nCoV", "Animal Model", "Animals", "Antibodies", "Antibody Response", "Antigens", "B-Lymphocytes", "Biological Assay", "COVID-19", "COVID-19 pandemic", "COVID-19 vaccine", "Cessation of life", "Cloning", "Collaborations", "Complex", "Coronavirus", "Coronavirus Infections", "Coronavirus spike protein", "Data", "Effectiveness", "Ensure", "Epidemic", "Epitope Mapping", "Epitopes", "Event", "Evolution", "Generations", "Goals", "Hamsters", "Health", "Human", "Immune response", "Immunity", "Immunize", "Individual", "Infection", "Lead", "Modeling", "Molecular", "Monoclonal Antibodies", "Mus", "Nature", "Patients", "Plasma", "Population", "Probability", "Readiness", "Reagent", "Recurrence", "Reporting", "Research", "SARS-CoV-2 infection", "SARS-CoV-2 spike protein", "SARS-CoV-2 variant", "Serology", "Speed", "Structure", "T cell response", "Techniques", "Testing", "Time", "Vaccination", "Vaccines", "Viral", "Virus", "Zoonoses", "base", "cohort", "combat", "design", "experience", "experimental study", "human disease", "human monoclonal antibodies", "improved", "mutant", "neutralizing antibody", "next generation", "nonhuman primate", "novel", "novel coronavirus", "pandemic disease", "prevent", "programs", "recruit", "response", "synergism", "therapy development", "vaccine development", "volunteer", "weapons", "zoonotic coronavirus" ], "approved": true } }, { "type": "Grant", "id": "9174", "attributes": { "award_id": "75N91019D00024-P00005-759102000004-2", "title": "COVID SARS-CoV-2 Assessment Viral Evolution (SAVE) VARIANT TESTING", "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": "2020-08-31", "end_date": "2022-08-30", "award_amount": 6477336, "principal_investigator": { "id": 24934, "first_name": "SALIBA", "last_name": "KATY", "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": "COVID SARS-CoV-2 Assessment Viral Evolution (SAVE) variant testing provides support for analysis of SARS-CoV-2 genome sequences from specimens collected in COVID-19 therapeutic and observational trials for genetic variants that could impact diagnostics, therapeutics, vaccine efficacy, and disease severity. COVID SAVE provides support for the analysis of the impact of SARS-CoV-2 variants on disease severity in animal models and in vitro neutralization assays. Additionally, COVID SAVE variant testing allows analysis of the evolution of SARS-CoV-2 and identification of future variants with potential public health impacts.", "keywords": [ "2019-nCoV", "Animal Disease Models", "Animal Model", "Biological Assay", "COVID-19", "COVID-19 therapeutics", "Clinical Research", "Complement", "Contracts", "Diagnostic", "Epidemiology", "Evolution", "Funding", "Future", "Genome", "Hypersensitivity", "Immune Evasion", "Immune response", "In Vitro", "Infection", "Institutes", "Monoclonal Antibodies", "Public Health", "Research Personnel", "SARS-CoV-2 genome", "SARS-CoV-2 variant", "Severity of illness", "Specimen", "Testing", "Therapeutic", "Variant", "Viral", "Virus", "coronavirus disease", "genetic variant", "genome sequencing", "human data", "targeted treatment", "vaccine efficacy", "whole genome" ], "approved": true } }, { "type": "Grant", "id": "7264", "attributes": { "award_id": "3UM1AI068618-14S2", "title": "CoVPN 3002 A Phase III Randomized, Double-blind, Placebo-controlled Multicenter Study in Adults to Determine the Safety, Efficacy, and Immunogenicity of AZD1222 for the Prevention of COVID-19 LAB", "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": "2020-09-04", "end_date": "2022-11-30", "award_amount": 6554653, "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 COVID-19 Prevention Network (CoVPN) Vaccines Leadership Operations Center (LOC) for implementation of the first COVID-19 vaccine efficacy trial “A Phase III Randomized, Double-blind, Placebo-controlled Multicenter Study in Adults to Determine the Safety, Efficacy, and Immunogenicity of AZD1222, A Non-replicating ChAdOx1 Vector Vaccine, for the Prevention of COVID- 19.” 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 Institute 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 64 United States (US) and 55 international clinical trial sites in 15 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 trial, a phase 3, placebo-controlled, double-blinded study will test the efficacy of AZD1222, a recombinant replication-defective chimpanzee adenovirus expressing the SARS-CoV-2 spike (S) surface glycoprotein, to modify COVID-19 disease in adults 18 year of age and older. Participants will be recruited from up to 100 clinical trial sites across the US, 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 at CoVPN laboratories, using qualified and validated assays for diagnosis and immune monitoring. Specific aims of this study are to demonstrate efficacy of AZD1222 to prevent COVID-19, to evaluate the safety, tolerability and reactogenicity of 2 injections given 4 weeks apart, to assess the ability to prevent infection with SARS-CoV-2, to assess the ability to modify COVID-19 disease, to assess the ability to prevent emergency room visits, and to evaluate the binding and neutralizing antibody responses. This efficacy trial will tell us much about the adaptive immune response in persons who receive a SARS-CoV-2 S protein based vaccine and about their ability to modify the disease course of COVID-19. In addition, it will improve our understanding of the dynamics and duration of these responses and will inform rational design and testing of preventive and therapeutic monoclonal antibody interventions. 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": [ "18 year old", "2019-nCoV", "Address", "Adenoviruses", "Adult", "Age-Years", "Antibody Response", "Antigens", "Binding", "Biological Assay", "Biometry", "COVID-19", "COVID-19 pandemic", "COVID-19 vaccine", "Cellular Assay", "Clinical", "Clinical Trials", "Clinical Trials Network", "Cohort Studies", "Communicable Diseases", "Constitution", "Country", "Data Analytics", "Development", "Diagnosis", "Disease", "Disease Outbreaks", "Dose", "Double-Blind Method", "Emergency department visit", "End Point Assay", "Eye", "Future", "Goals", "HIV Vaccine Trials Network", "HIV vaccine", "Health", "Hospitalization", "Immune", "Immune response", "Immunity", "Immunologic Monitoring", "Immunology", "Individual", "Infection", "Infection Control", "Infection prevention", "Injections", "International", "Intervention", "Knowledge", "Laboratories", "Lead", "Leadership", "Malaria", "Mediating", "Membrane Glycoproteins", "Monitor", "Morbidity - disease rate", "Multicenter Studies", "Pan Genus", "Participant", "Persons", "Phase", "Physicians", "Placebos", "Population", "Preparation", "Prevention", "Preventive", "Proteins", "Protocols documentation", "Quality Control", "Randomized", "Randomized Clinical Trials", "Recombinants", "Research Methodology", "Risk", "Safety", "Sampling", "Scientist", "Serological", "Serum", "Severities", "Site", "System", "Testing", "Therapeutic Monoclonal Antibodies", "Typhoid Fever", "United States", "United States National Institutes of Health", "Vaccines", "Validation", "adaptive immune response", "base", "clinical trial analysis", "design", "efficacy study", "efficacy testing", "efficacy trial", "experience", "high risk", "immune function", "immunogenicity", "improved", "mortality", "neutralizing antibody", "operation", "prevent", "programs", "quality assurance", "racial and ethnic", "racial diversity", "recruit", "response", "screening", "vaccine trial", "vector vaccine" ], "approved": true } }, { "type": "Grant", "id": "11377", "attributes": { "award_id": "1UG3HL164285-01", "title": "1/2 REPRIEVE Extension for Trial Completion", "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": 10288, "first_name": "Patrice", "last_name": "Desvigne-Nickens", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2023-05-01", "end_date": "2024-04-30", "award_amount": 6567877, "principal_investigator": { "id": 10289, "first_name": "Pamela Susan", "last_name": "Douglas", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [ { "id": 736, "ror": "https://ror.org/002pd6e78", "name": "Massachusetts General Hospital", "address": "", "city": "", "state": "MA", "zip": "", "country": "United States", "approved": true } ] }, "other_investigators": [ { "id": 10290, "first_name": "STEVEN K.", "last_name": "GRINSPOON", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "awardee_organization": { "id": 736, "ror": "https://ror.org/002pd6e78", "name": "Massachusetts General Hospital", "address": "", "city": "", "state": "MA", "zip": "", "country": "United States", "approved": true }, "abstract": "Project Summary-Abstract Globally, cardiovascular disease (CVD) burden is increasing and a major cause of mortality among people with HIV (PWH). However, data are not yet available from large trials on an effective primary CVD prevention strategy for PWH. The ongoing REPRIEVE trial will address this critical knowledge gap, hypothesizing that statin therapy, with pleiotropic effects on LDL, immune activation and inflammatory pathways, will modify traditional and nontraditional risks and prevent major adverse cardiovascular events (MACE) in PWH. REPRIEVE is well-positioned to provide high quality, clinically actionable and generalizable information to shift the current paradigm of HIV care, in alignment with the goals of NHLBI and OAR to reduce CVD and improve the overall health of PWH. REPRIEVE has met major challenges, anticipated for a large trial. 7,770 participants (31% female, 43% Black, 25% Latino) were enrolled from over 100 sites in 12 countries, a diverse, generalizable population. Retention is high, >90%. Endpoint (MACE) are accumulating steadily despite a low median ASCVD risk score of 4.5%, consistent with the hypothesis that nontraditional risks contribute to CVD in HIV. The Mechanistic Substudy has met its goal, enrolling over 800 participants for serial coronary CT angiography (CTA) and immune function. Preliminary baseline data from the substudy support our hypothesis, linking plaque to CVD risk but also independently to IL-6 and Lp-PLA2, key indices of immune function and arterial inflammation that are being targeted in REPRIEVE. Moreover, REPRIEVE is being leveraged to assess statin effects on COVID severity, and long-term effects in PWH, critical unanswered questions for the field. REPRIEVE has executed well over 6 years and is fundamentally strong. However, with a long duration of recruitment and protocol revisions to identify the optimal at-risk group given new guidelines, median duration of follow up is still short at 3.5 years. REPRIEVE needs additional time, projected at 2 years, plus a close out year, to collect necessary MACE to ensure adequate power, analyze, and disseminate this data. The pressing need for data from a large global primary prevention trial has only grown since REPRIEVE was initiated. Completion of the trial will protect the value of the initial NIH investment and honor the commitment to our participants and scientific community to meet the Aims of the trial. This application for the Clinical Coordinating Center (CCC) of the REPRIEVE Extension for Trial Completion focuses on the clinical rationale and coordination of the trial. The Data Coordinating Center (DCC) application focuses on data management, including the coronary CTA data of the Mechanistic Substudy, and the statistical rationale for the trial design.", "keywords": [ "Acquired Immunodeficiency Syndrome", "Address", "Angiography", "Antibodies", "Antibody Response", "Arterial Fatty Streak", "Biological Factors", "Black race", "CCL2 gene", "COVID-19 severity", "Cardiac", "Cardiovascular Diseases", "Cardiovascular system", "Caring", "Characteristics", "Clinical", "Coagulation Process", "Communities", "Coronary", "Coronary Arteriosclerosis", "Country", "Data", "Data Coordinating Center", "Diet", "Dyslipidemias", "Enrollment", "Ensure", "Environment", "Epidemiology", "Event", "Female", "Fibrin fragment D", "Funding", "Genes", "Genetic", "Glucose", "Goals", "Guidelines", "HIV", "Health", "Heart failure", "Immune", "Immunoglobulin A", "Immunoglobulin G", "Immunologics", "Incidence", "Infection", "Inflammation", "Inflammatory", "Insulin", "Integration Host Factors", "Interleukin-6", "Investments", "Knowledge", "Latino", "Life Style", "Link", "Lipids", "Liver Dysfunction", "Long-Term Effects", "Low-Density Lipoproteins", "Malignant Neoplasms", "Mediating", "Morphology", "Myositis", "National Heart Lung and Blood Institute", "Outcome", "Participant", "Pathway interactions", "Persons", "Phenotype", "Population", "Populations at Risk", "Positioning Attribute", "Prevention strategy", "Prevention trial", "Primary Prevention", "Proteins", "Proteomics", "Protocols documentation", "Risk", "Risk Factors", "SARS-CoV-2 infection", "Safety", "Serotyping", "Severities", "Site", "Smoking", "Symptoms", "T-Lymphocyte", "Time", "United States National Institutes of Health", "Update", "Viral Load result", "adjudication", "attenuation", "burden of illness", "cardiovascular disorder prevention", "cardiovascular disorder risk", "cardiovascular risk factor", "clinical application", "clinically actionable", "cohort", "coronary computed tomography angiography", "coronary plaque", "coronavirus disease", "data management", "experience", "follow-up", "high risk", "immune activation", "immune function", "improved", "indexing", "lipoprotein-associated phospholipase A(2)", "monocyte", "mortality", "novel", "oxidized low density lipoprotein", "participant enrollment", "pleiotropism", "predictive marker", "prevent", "primary endpoint", "recruit", "risk prediction", "transcriptomics", "trial design" ], "approved": true } }, { "type": "Grant", "id": "9049", "attributes": { "award_id": "3U54EB027049-02S1", "title": "The Center for Innovation in Point-of-Care Technologies for HIV/AIDS atNorthwestern University (C-THAN) Supplemental Request", "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": "2020-05-21", "end_date": "2022-05-22", "award_amount": 6707769, "principal_investigator": { "id": 24851, "first_name": "SALLY Maureen", "last_name": "MCFALL", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [ { "id": 317, "ror": "https://ror.org/000e0be47", "name": "Northwestern University", "address": "", "city": "", "state": "IL", "zip": "", "country": "United States", "approved": true } ] }, "other_investigators": [ { "id": 24852, "first_name": "ROBERT L.", "last_name": "MURPHY", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "awardee_organization": { "id": 317, "ror": "https://ror.org/000e0be47", "name": "Northwestern University", "address": "", "city": "", "state": "IL", "zip": "", "country": "United States", "approved": true }, "abstract": "The “C-THAN POCTRN COVID-19 Proposal” is a supplement to the existing Center for Innovation in Point-of- Care Technologies for HIV/AIDS at Northwestern (C-THAN) which aims to support development of technologies which can help address the urgent healthcare needs created by the COVID-19 pandemic. The extent and urgency of the situation requires an aggressive and innovative approach to accelerate the delivery of solutions to address immediate and future needs. Our approach augments the strong technical and clinical expertise within our own and the existing four POCTRN centers and their Coordinating Center. The specific aims are: 1) develop a SARS-CoV-2 ten-minute molecular diagnostic test based on the Minute Molecular Platform; and 2) scale up C-THAN’s established international network for COVID-19 technological development and testing of relevant products and assays in sub-Saharan Africa and other low- and middle- income countries (LMICs). For aim 1, C-THAN proposes the development of a ten-minute SARS-CoV-2 test for the Minute Molecular DASH (Diagnosis Analyzer for Selective Hybridization), a sample-to-answer platform for point-of-care use in medical clinics, emergency departments and urgent care centers. The DASH platform exploits novel fast PCR and microfluidic fabrication technologies developed at the Center for Innovation in Global Health Technologies (CIGHT) at Northwestern University. DASH technology can be adapted for high throughput uses such as airports, hospitals, nursing homes, emergency departments and drive-through testing sites. For aim 2, we will scale up C-THAN resources to expand addressing the impact of the pandemic. The C-THAN network consists of four biomedical engineering (BME) technology development sites plus three clinical validation/needs assessment sites. The BME sites include University of Cape Town and Stellenbosch University in South Africa, and University of Lagos and University of Ibadan in Nigeria. The seven clinical validation/needs assessment sites include ones located with the engineering sites plus at University of Jos in Nigeria, University of Bamako in Mali and Muhimbili University in Tanzania. The relationship of these sites with Northwestern University go back up to 22 years. We will utilize Northwestern’s Institute for Global Health Catalyzer Award Program which has been funding promising research projects addressing critical global health needs for over 10 years. Two weeks ago, the Institute redirected all proposals to address only COVID-19 activities. Basic scientists, biomedical engineers, infectious diseases specialists, virologist, pharmacologists and public health faculty are encouraged to apply for Catalyzer awards which are in the range of $25,000 for a one-year project. With this POCTRN supplement, we will “plus-up” these awards to a maximum of $100,000 each to increase the scope and pace of the development. Applications are being accepted on a rolling basis, and funding decisions are made within 7 days. These two approaches will rapidly accelerate the development of promising COVID-19 technologies both in the US and globally.", "keywords": [ "2019-nCoV", "AIDS/HIV problem", "Accident and Emergency department", "Address", "Africa South of the Sahara", "African", "Authorization documentation", "Award", "Back", "Biological Assay", "Biomedical Engineering", "COVID-19", "COVID-19 pandemic", "Care Technology Points", "Caring", "Clinic", "Clinical", "Communicable Diseases", "Development", "Diagnosis", "Diagnostic", "Disease", "Emergency Situation", "Engineering", "Faculty", "Funding", "Future", "Health Technology", "Healthcare", "Hospital Nursing", "Institutes", "International", "Mali", "Medical", "Methods", "Microfluidics", "Molecular", "Molecular Diagnostic Testing", "Needs Assessment", "Nigeria", "Nursing Homes", "Policies", "Polymerase Chain Reaction", "Public Health", "Research Project Grants", "Reverse Transcription", "Sampling", "Scientist", "Site", "South Africa", "Specialist", "Specimen", "Tanzania", "Technology", "Testing", "Time", "United States Food and Drug Administration", "Universities", "University resources", "Validation", "base", "global health", "innovation", "low and middle-income countries", "novel", "pandemic disease", "point of care", "programs", "public health emergency", "respiratory", "scale up", "technology development", "urgent care" ], "approved": true } }, { "type": "Grant", "id": "8744", "attributes": { "award_id": "1C06OD032019-01", "title": "Establishment of the Bat Resource Center for the Study of Zoonotic Diseases", "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": 23882, "first_name": "CHARLES ASHLEY", "last_name": "Barnes", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2021-09-20", "end_date": "2026-05-31", "award_amount": 6748541, "principal_investigator": { "id": 24535, "first_name": "Gregory David", "last_name": "Ebel", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [ { "id": 323, "ror": "https://ror.org/03k1gpj17", "name": "Colorado State University", "address": "", "city": "", "state": "CO", "zip": "", "country": "United States", "approved": true } ] }, "other_investigators": [], "awardee_organization": { "id": 323, "ror": "https://ror.org/03k1gpj17", "name": "Colorado State University", "address": "", "city": "", "state": "CO", "zip": "", "country": "United States", "approved": true }, "abstract": "This proposal outlines request to establish the Bat Resource Center for the Study of Zoonotic Diseases at Colorado State University. The Bat Resource Center is a $7.99M facility located adjacent to the Center for Vectorborne Disease and the Rocky Mountain Regional Biocontainment Laboratory. It is uniquely designed to be a vivarium with the necessary environmental and biosafety controls to successfully breed and maintain bats for use as animal models. This important animal model is critical to our understanding of viral pathogenesis and disease transmission as bats have been shown to be a reservoir for a number of human pathogens including the recent COVID-19 pandemic. The Bat Resource Center will greatly enhance our abilities to study these agents and will serve as a national resource for others using bat models.", "keywords": [ "Animal Model", "COVID-19 pandemic", "Chiroptera", "Colorado", "Disease", "Laboratories", "Modeling", "Resources", "Universities", "Vector-transmitted infectious disease", "Viral Pathogenesis", "Virus Diseases", "Zoonoses", "design", "disease transmission", "human pathogen" ], "approved": true } } ], "meta": { "pagination": { "page": 1405, "pages": 1424, "count": 14236 } } }