Grant List
Represents Grant table in the DB
GET /v1/grants?page%5Bnumber%5D=4&sort=-abstract
{ "links": { "first": "https://cic-apps.datascience.columbia.edu/v1/grants?page%5Bnumber%5D=1&sort=-abstract", "last": "https://cic-apps.datascience.columbia.edu/v1/grants?page%5Bnumber%5D=1419&sort=-abstract", "next": "https://cic-apps.datascience.columbia.edu/v1/grants?page%5Bnumber%5D=5&sort=-abstract", "prev": "https://cic-apps.datascience.columbia.edu/v1/grants?page%5Bnumber%5D=3&sort=-abstract" }, "data": [ { "type": "Grant", "id": "6009", "attributes": { "award_id": "3P01AI117915-07S1", "title": "Early Life Vaccination to Prevent HIV acquisition during Adolescence", "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": 20536, "first_name": "Anjali", "last_name": "Singh", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2015-04-01", "end_date": "2023-03-31", "award_amount": 299339, "principal_investigator": { "id": 20537, "first_name": "Kristina", "last_name": "De Paris", "orcid": null, "emails": "[email protected]", "private_emails": null, "keywords": "[]", "approved": true, "websites": "[]", "desired_collaboration": "", "comments": "", "affiliations": [ { "id": 825, "ror": "", "name": "WEILL MEDICAL COLL OF CORNELL UNIV", "address": "", "city": "", "state": "NY", "zip": "", "country": "United States", "approved": true } ] }, "other_investigators": [ { "id": 20538, "first_name": "Sallie R.", "last_name": "Permar", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "awardee_organization": { "id": 825, "ror": "", "name": "WEILL MEDICAL COLL OF CORNELL UNIV", "address": "", "city": "", "state": "NY", "zip": "", "country": "United States", "approved": true }, "abstract": "– Overall Nearly 600,000 new HIV infections occur yearly in adolescents/young adults (ages 15-24 years), the only population in which HIV infections continue to rise. The end of the HIV/AIDS epidemic will be achievable only when an effective vaccine regimen can elicit long-term protective immunity in preadolescence, prior to sexual debut. Yet, even the most promising HIV envelope (Env) vaccine platforms have failed to induce highly- protective immunity in adults in preclinical and clinical studies. Interestingly, recent studies indicate that durable, polyfunctional, and broad neutralizing antibody (bnAb) responses following HIV infection occur more frequently and are equal or more potent in infants compared to that of adults. Yet, there remains a gap in our understanding of the immunologic mechanisms associated with the rapid induction of HIV bnAb and effector antibody functions within the infant immune landscape. The overall goal of this HIVRAD renewal is to harness the unique qualities of the early life immune system for vaccine elicitation of protective HIV immunity. This work builds on our current HIVRAD Program focusing on the development of HIV Env vaccine regimens for prevention of infant HIV acquisition. We defined the optimal vaccine intervals, adjuvants, and doses to achieve maximal immunogenicity in the infant immune system, and determined that concurrent passive bnAb-active HIV Env immunization does not impair vaccine-elicited immune responses. In this renewal HIVRAD Program, we hypothesize that HIV Env vaccine platforms administered in early life and boosted in preadolescence will achieve more durable, broad, and polyfunctional immune responses and be more efficacious at prevention of sexual transmission than initiation of immunization in preadolescence. We will compare vaccine responses to two of the most promising HIV Env vaccine candidates, bnAb germline-targeting SOSIP trimers (Project 1) and lipid nanoparticle mRNA vaccines (Project 2) initiated in infancy with boosting throughout childhood to that of initiation of vaccination in preadolescence in the rhesus model (Nonhuman Primate (NHP) Core), and test their efficacy against intrarectal homologous and heterologous SHIV challenge in adolescence. We will apply systems immunology to define the immunologic, transcriptomic, and microbiologic signatures associated with the HIV Env vaccine antibody function and induction of bnAb precursors (Integrated Systems Immunology Core (ISIC)). The Administrative Core provides the full range of support for scientific, fiscal, and other programmatic management and oversight. By leveraging the extended window for maturation of vaccine-induced responses and defining the mechanistic advantages of early life immunization for effective anti-HIV responses, this Program will inform the target population and design of an HIV Env vaccine that will provide life-long protection.", "keywords": [ "AIDS/HIV problem", "Achievement", "Adjuvant", "Adolescence", "Adolescent", "Adult", "Age", "Antibodies", "Antibody Response", "Antibody-mediated protection", "Antigens", "Autologous", "B-Lymphocytes", "Cell Communication", "Cell Lineage", "Cells", "Childhood", "Clinical Research", "Collaborations", "Development", "Dose", "Epidemic", "Evolution", "Funding", "Future", "Goals", "HIV", "HIV Infections", "HIV vaccine", "HIV-1", "Human", "Human Milk", "Immune", "Immune response", "Immune system", "Immunity", "Immunization", "Immunize", "Immunoglobulin Somatic Hypermutation", "Immunologics", "Immunology", "Infant", "Infection", "Infrastructure", "Life", "Macaca mulatta", "Mediating", "Messenger RNA", "Microbiology", "Modeling", "Molecular", "Monkeys", "Passive Immunization", "Pathway interactions", "Plasma", "Population", "Prevention", "RNA vaccine", "Regimen", "Rhesus", "Risk", "Sexual Transmission", "System", "Systems Biology", "Target Populations", "Testing", "Time", "Translations", "Vaccination", "Vaccine Clinical Trial", "Vaccine Design", "Vaccines", "Vertical Disease Transmission", "Virus", "Woman", "Work", "Youth", "age group", "design", "immunogenicity", "infancy", "insight", "lipid nanoparticle", "microbial", "microbial signature", "microbiome", "microbiota", "microorganism interaction", "neutralizing antibody", "nonhuman primate", "novel", "preadolescence", "preclinical study", "predictive signature", "prevent", "programs", "response", "sexual debut", "simian human immunodeficiency virus", "transcriptome", "transcriptomics", "transmission process", "vaccination strategy", "vaccine candidate", "vaccine response", "vaccine-induced antibodies", "young adult" ], "approved": true } }, { "type": "Grant", "id": "5205", "attributes": { "award_id": "1U19AI167903-01", "title": "Systems biological assessment of innate and adaptive immunity to vaccination", "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": 18429, "first_name": "Mary Chelsea", "last_name": "Lane", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2022-03-07", "end_date": "2027-02-28", "award_amount": 2168222, "principal_investigator": { "id": 18430, "first_name": "BALI", "last_name": "PULENDRAN", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [], "awardee_organization": { "id": 266, "ror": "https://ror.org/00f54p054", "name": "Stanford University", "address": "", "city": "", "state": "CA", "zip": "", "country": "United States", "approved": true }, "abstract": "– Overall Component In the current proposal we will use a systems vaccinology approach to address two fundamental issues in vaccinology. The first issue concerns the immunology of COVID-19 vaccines, which utilize novel platforms (mRNA) or adjuvants (Matrix M used in the Novavax vaccine). The second issue is related to the role of the microbiome on vaccine immunity. With respect to the first issue, despite the rapid development of COVID- 19 vaccines, there is a paucity of understanding about the mechanisms by which they induce innate and adaptive responses. Furthermore, the nature of the immune response induced by mRNA vaccines in special populations such as those with serious allergic disease is unknown. Interestingly, there have been reports of rare but severe allergic reactions to vaccination, in individuals with an atopic background. Therefore, we will assess immunity to the BNT162b2 vaccine atopic versus healthy subjects. In the case of the Matrix-M adjuvanted recombinant COVID-19 vaccine developed by Novavax, there is a paucity of understanding of immune mechanisms stimulated by the saponin-based Matrix-M adjuvant. We will analyze samples collected from a Novavax sponsored clinical trial in South Africa. The second theme of the proposal is focused on the impact of the microbiome on immunity to vaccination in healthy adults. Our recent work involving antibiotics driven ablation of the microbiota has highlighted an important role for the microbiome in modulating immune responses to vaccination with the seasonal influenza vaccine. However, the immune response against seasonal influenza vaccine in adults represents a recall response, because of prior exposure to influenza. The impact of the microbiome on a primary immune response, such as the response to rabies vaccination, is unknown. These two issues will be addressed in the following highly collaborative projects and cores: Project 1 (PI Pulendran) will utilize a multi-omics approach to define innate responses driving adaptive immunity immunity to vaccination. The signatures identified in this project will be correlated with antigen-specific T and B cell responses assessed in Projects 2 (PI Davis) and 3 (PI Boyd), respectively. Project 2 will perform an in-depth analysis of the dynamics of the antigen-specific T cell responses to vaccination. Project 3 (PI Boyd; Co-I Nadeau) will perform an in-depth analysis of the dynamics of the antigen-specific B cell responses to vaccination. The three projects will be assisted by 4 cores. The Administrative Core will support the coordination efforts across the HIPC-Stanford Center. The Clinical Core (PI Nadeau) will ensure a standardized approach in the recruitment and clinical characterization of human subjects in all studies; the Data Management and Analysis Core (PI Khatri) will provide bioinformatics expertise, and the Human Immune Monitoring Core (PI Holden) will support the projects by providing immune monitoring assays.", "keywords": [ "Ablation", "Address", "Adjuvant", "Adult", "Algorithms", "Allergic Disease", "Allergic Reaction", "Antibiotics", "Antigens", "Automobile Driving", "Award", "B-Lymphocytes", "Bioinformatics", "Biological Assay", "Biological Markers", "COVID-19 vaccine", "Cells", "Clinical", "Clinical Trials", "Computer Models", "Cytometry", "Data Analyses", "Data Security", "Data Storage and Retrieval", "Databases", "Development", "Ensure", "Exposure to", "Human", "Immune", "Immune response", "Immunity", "Immunologic Monitoring", "Immunology", "Individual", "Influenza", "Investigation", "Messenger RNA", "Molecular Profiling", "National Institute of Allergy and Infectious Disease", "Natural Immunity", "Nature", "Pfizer-BioNTech COVID-19 vaccine", "Plasma", "Population", "Predisposition", "RNA vaccine", "Rabies", "Recombinants", "Reporting", "Research Personnel", "Research Project Grants", "Role", "Sampling", "Saponins", "Services", "South Africa", "South African", "Special Population", "Standardization", "System", "T cell response", "T-cell receptor repertoire", "Technology", "Time", "Vaccination", "Vaccines", "Validation", "Work", "adaptive immunity", "antigen-specific T cells", "base", "biological systems", "cytokine", "data integration", "data management", "data submission", "epigenomics", "human subject", "influenza virus vaccine", "insight", "metabolomics", "microbiome", "microbiota", "multiple omics", "new technology", "novel", "recruit", "response", "seasonal influenza", "single cell analysis", "transcriptomics", "vaccine development", "vaccinology" ], "approved": true } }, { "type": "Grant", "id": "5828", "attributes": { "award_id": "3P20GM125498-04S1", "title": "Multi-Scale Modeling of SARS-CoV-2 Dissemination Dynamics", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Institute of General Medical Sciences (NIGMS)" ], "program_reference_codes": [], "program_officials": [ { "id": 20001, "first_name": "FEDERICO", "last_name": "Bernal", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2018-09-15", "end_date": "2023-07-31", "award_amount": 322445, "principal_investigator": { "id": 20002, "first_name": "Beth Diane", "last_name": "Kirkpatrick", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [], "awardee_organization": { "id": 1131, "ror": "", "name": "UNIVERSITY OF VERMONT & ST AGRIC COLLEGE", "address": "", "city": "", "state": "VT", "zip": "", "country": "United States", "approved": true }, "abstract": "– Overall Component Despite striking advances in the 20th and early 21st century, infectious diseases are dynamic, ever-evolving global threats that cause significant morbidity and mortality in all populations worldwide. Within a single year, Zika has emerged, massive outbreaks of cholera have occurred, and antimicrobial resistance has become a critical international concern. This landscape demands new approaches to prevent and control infectious diseases, and the training of new scientists to meet these demands. New approaches will require interpretation of big data sets, including data from both the biologic sciences (“systems biology” and “-omics”) and advanced epidemiology. This University of Vermont COBRE will be focused on Translational Research to Prevent and Control Global Infectious Diseases. “The TGIR Center” (Translational Global Infectious Diseases Research) will integrate a novel multi-disciplinary research team of biomedical and mathematical/computational scientists. The team will work toward novel and impactful research to diminish the burden of globally-important infectious diseases by bridging the culture gaps between the biologic and mathematical/computational fields of biomedical research. Our center will leverage substantial existing strengths at UVM in Global Infectious Diseases Research, and strengths in complex systems and computational modeling. A team of experienced directors, scientific advisors/mentors, and two new core facilities (“Mathematical and Computational Predictive Modeling” and “Human and Population Research”), will foster collaborative and novel research. The TGIR will develop four outstanding, existing junior faculty under the mentorship of senior scientific advisors from three UVM colleges and five departments. Institutional support will enable recruitment of three new junior faculty and will provide space for a new Innovation and Collaboration laboratory, the latter also supported by the proposed Alteration and Renovation component. Internal and external advisory committees will provide formal, unbiased oversight. Junior faculty will find a robust, well-organized academic home in the TGIR COBRE: a strong mentoring and career-development program, a center-wide seminar series and coursework, and research support from multi-disciplinary senior faculty teams in both research cores.", "keywords": [ "2019-nCoV", "Advisory Committees", "Antimicrobial Resistance", "Big Data", "Biological", "Biological Sciences", "Biomedical Research", "Center for Translational Science Activities", "Centers of Research Excellence", "Cholera", "Clinical", "Clinical Trials", "Collaborations", "Communicable Diseases", "Complement", "Complex", "Computer Models", "Core Facility", "Data", "Data Set", "Development", "Discipline", "Disease Outbreaks", "Epidemiology", "Faculty", "Faculty Recruitment", "Fostering", "Goals", "Growth", "Home", "Human", "Immunology", "Infectious Diseases Research", "Interdisciplinary Study", "International", "Laboratories", "Lead", "Mathematics", "Mentors", "Mentorship", "Methods", "Molecular", "Morbidity - disease rate", "Parasitology", "Physicians", "Population", "Population Research", "Prevention", "Program Development", "Research", "Research Infrastructure", "Research Personnel", "Research Support", "Science", "Scientist", "Series", "Structure", "System", "Systems Biology", "Talents", "Teacher Professional Development", "Training", "Translational Research", "Universities", "Vaccines", "Vermont", "Work", "ZIKA", "career development", "college", "design", "experience", "global health", "improved", "innovation", "interest", "member", "mortality", "multi-scale modeling", "multidisciplinary", "novel", "novel strategies", "novel therapeutics", "predictive modeling", "prevent", "programs", "recruit", "senior faculty", "success", "symposium", "synergism" ], "approved": true } }, { "type": "Grant", "id": "15933", "attributes": { "award_id": "3U19AI118626-11S1", "title": "Respiratory pathogen-specific T cell signatures following vaccination, natural infection, and treatment", "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": 32843, "first_name": "JOSEPH J", "last_name": "BREEN", "orcid": "", "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2025-06-01", "end_date": "2027-05-31", "award_amount": 93590, "principal_investigator": { "id": 20714, "first_name": "Alessandro", "last_name": "Sette", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [ { "id": 777, "ror": "", "name": "LA JOLLA INSTITUTE FOR IMMUNOLOGY", "address": "", "city": "", "state": "CA", "zip": "", "country": "United States", "approved": true } ] }, "other_investigators": [], "awardee_organization": { "id": 777, "ror": "", "name": "LA JOLLA INSTITUTE FOR IMMUNOLOGY", "address": "", "city": "", "state": "CA", "zip": "", "country": "United States", "approved": true }, "abstract": "– Overall The La Jolla HIPC team will focus on pathogens causing infectious diseases of the upper and lower respiratory tract that lead to substantial mortality and morbidity. Our approach is unique and innovative, as it focuses on defining immune signatures (IMS) of antigen-specific CD4 and CD8 T cells generated in response to natural infection with important respiratory pathogens such as SARS-CoV-2, Common Cold Coronaviruses (CCC), influenza, Respiratory Syncytial Virus (RSV) and Mycobacterium tuberculosis (Mtb). Likewise, our Program will investigate IMS of antigen-specific T cells generated following vaccination against a diverse array of pathogens in different platforms like attenuated pathogens (BCG, yellow fever (YF)), purified proteins (acellular Bordetella pertussis (PT) vaccines), viral vectors (J&J, SARS-CoV-2) and mRNA (Moderna and Pfizer). In Project 1, we will perform longitudinal analysis to determine persistence and plasticity of antigen-specific T cell responses following natural SARS-CoV-2 infection and vaccination. We will study T cell responses specific to SARS-CoV-2 following vaccination with different vaccine platforms in previously-unvaccinated donors, and in a longitudinal cohort of vaccinated individuals previously naturally-infected with SARS-CoV-2. In parallel studies, we will analyze T cell responses to SARS-CoV-2 in naturally-infected unvaccinated donors. We will also analyze T cell responses in two previously-enrolled cohorts who received YF and PT vaccinations; in both cohorts the natural evolution and persistence of T cell responses to CCC viruses will be investigated. In Project 2, we will perform longitudinal analysis of the IMS of Mtb-specific T cells. Here, we will build on our progress made during the previous HIPC funding period to characterize the IMS associated with latent and active TB disease as well as BCG vaccination. Specifically, we will characterize the longitudinal IMS of both active and latent TB during treatment. In parallel, we will characterize the longitudinal IMS of adults (re)vaccinated with BCG, and characterize the IMS of Mtb-specific T cells in the lung. In Project 3, we will determine the molecular properties of pathogen-specific lung tissue-resident memory T cells (TRM). Our goal is to establish a single-cell atlas of the transcriptome, epigenome, and T cell receptor (TCR) of antigen-specific lung TRM targeting common pathogens that infects the lungs such as: viral (influenza, RSV, para influenza, meta pneumovirus, SARS-CoV-2, CCC), bacterial (pneumococcus, PT, Mtb) and fungal pathogens. The longitudinal study design will enable assessment of plasticity and persistence of lung TRM cells following natural infection and vaccination. The synergy between Projects will allow the generation of cross- comparable large-scale single-cell T cell signatures for respiratory pathogens/vaccines.", "keywords": [ "2019-nCoV", "Address", "Adult", "Antigens", "Atlases", "Attenuated", "Bacille Calmette-Guerin vaccination", "Bacteria", "Blood", "Bordetella pertussis", "CD8-Positive T-Lymphocytes", "CD8B1 gene", "Cells", "Cellular Assay", "Clinical", "Common Cold", "Communicable Diseases", "Communication", "Coronavirus", "Disease", "Enrollment", "Ensure", "Epitopes", "Evolution", "Flow Cytometry", "Funding", "Generations", "Goals", "Immune", "Immune response", "Infection", "Influenza", "Longitudinal cohort", "Lower respiratory tract structure", "Lung", "Molecular", "Morbidity - disease rate", "Mycobacterium tuberculosis", "National Institute of Allergy and Infectious Disease", "Pertussis", "Pertussis Vaccine", "Phenotype", "Play", "Pneumovirus", "Property", "Recurrence", "Resources", "Respiratory Tract Infections", "Respiratory syncytial virus", "Risk", "Role", "SARS-CoV-2 infection", "Services", "Severity of illness", "Sorting", "Streptococcus pneumoniae", "Structure of parenchyma of lung", "Systems Biology", "T cell response", "T memory cell", "T-Cell Receptor", "T-Lymphocyte", "T-Lymphocyte Subsets", "T-cell receptor repertoire", "Technology", "Time", "Tissues", "Upper respiratory tract", "Vaccinated", "Vaccination", "Vaccinee", "Vaccines", "Viral", "Viral Vector", "Virus", "Yellow Fever", "adaptive immunity", "antigen-specific T cells", "biomarker panel", "burden of illness", "cohort", "cost effective", "current pandemic", "data management", "design", "epigenome", "innovation", "longitudinal analysis", "longitudinal design", "mortality", "pathogen", "pathogenic fungus", "programs", "protein purification", "respiratory pathogen", "response", "single cell ATAC-seq", "success", "synergism", "tissue resident memory T cell", "transcriptome", "transcriptomics", "unvaccinated", "vaccine platform" ], "approved": true } }, { "type": "Grant", "id": "7318", "attributes": { "award_id": "3R01DC016273-03S1", "title": "Administrative Supplement to The When to Worry about Language Study (W2W-L)", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Institute on Deafness and Other Communication Disorders (NIDCD)" ], "program_reference_codes": [], "program_officials": [ { "id": 10587, "first_name": "Judith", "last_name": "Cooper", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2018-03-05", "end_date": "2023-02-28", "award_amount": 197084, "principal_investigator": { "id": 23107, "first_name": "Elizabeth Spencer", "last_name": "Norton", "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": 23108, "first_name": "LAUREN S", "last_name": "WAKSCHLAG", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [ { "id": 924, "ror": "", "name": "NORTHWESTERN UNIVERSITY AT CHICAGO", "address": "", "city": "", "state": "IL", "zip": "", "country": "United States", "approved": true } ] } ], "awardee_organization": { "id": 317, "ror": "https://ror.org/000e0be47", "name": "Northwestern University", "address": "", "city": "", "state": "IL", "zip": "", "country": "United States", "approved": true }, "abstract": "– Original Submission Primary language impairment (PLI) begins early in life and affects 6-8% of children. Although language intervention is maximally effective the earlier it is delivered, normative variation in language acquisition across toddlerhood (here 24-36 months) impedes accurate identification of PLI prior to late preschool age. The proposed study introduces a novel, theoretically- grounded, neurodevelopmental framework designed to generate a sensitive and specific model to identify PLI as early as possible. Our developmentally- sensitive, translational approach introduces multiple innovations including: (1) characterizing the developmental patterning of toddler emergent language beginning at 24 mos. using state-of-the-art methods, within a large community sample; (2) incorporating EEG/ERP neural biomarkers of language into PLI risk assessment; (3) using a novel paradigm to assess the protective effects of both behavioral and neural synchronization within parent-child language transactions; and (4) consideration of irritability, a robust developmental marker of early mental health risk, to enhance identification of those language delayed toddlers at highest risk for persistence. For the proposed When to Worry about Language Study (W2W-L), we capitalize on our funded study of 350 infants (50% irritable and 50% non-irritable) (R01MH107652, Wakschlag, PI) and enrich it via recruitment of a sub-sample of 200 late talking toddlers. This will yield a large and diverse sample of 550 24-month-olds. Our key predictors will be toddler emergent language patterns (24-36 months), their neural biomarkers and synchrony within the transactional language environment. Our central outcome is primary language impairment (PLI) status at preschool age (54 mos., when PLI can be reliably evaluated), assessed via clinical gold standard expressive and receptive language abilities. SPECIFIC AIMS: AIM 1a. Evaluate accuracy of PLI prediction based on multi-component measures of language including intensive longitudinal assessments of toddler developmental precursors of key language functions at older ages, neural biomarkers. We will assess neural and linguistic processing via quantitative EEG during parent-child interaction and ERPs to speech sounds as well as during eye tracking tasks and 1b. Evaluate feasibility of creating an algorithm for early identification of PLI that can be applied in clinical practice, using cross-validation and machine learning. AIM 2: Test the hypothesis that parent-child dyadic synchrony buffers PLI risk For the first time, we combine behavioral and novel social EEG measures of parent-child synchrony during natural interaction and a custom-designed word learning task to directly test how observed (behavioral) and neural (EEG) dyadic synchrony impact word learning. AIM 3: Test whether consideration of toddler irritability enhances PLI prediction. In sum, PLI confers sustained negative effects on a variety of personal-social and academic outcomes. Pinpointing children at highest risk for PLI is critical for reducing the public health burden of PLI for children, families, and the systems supporting them, and enhancing targeted allocation of resources.", "keywords": [ "Address", "Administrative Supplement", "Adverse effects", "Affect", "African American", "Age", "Algorithms", "Behavioral", "Biological Markers", "Buffers", "COVID-19", "COVID-19 pandemic", "Caregivers", "Child", "Child Language", "Child Rearing", "Clinical", "Communities", "Custom", "Data", "Data Collection", "Development", "Early Intervention", "Early identification", "Electroencephalography", "Environment", "Family", "Family member", "Foundations", "Funding", "Goals", "Gold", "Hispanics", "Home environment", "Human Subject Research", "Illinois", "Impairment", "Individual", "Infant", "Institutes", "Interruption", "Intervention", "Language", "Language Delays", "Language Development", "Language Disorders", "Life", "Linguistics", "Machine Learning", "Measures", "Mediating", "Mental Health", "Methods", "Modeling", "Nursery Schools", "Outcome", "Parent-Child Relations", "Parents", "Participant", "Pattern", "Pediatric Hospitals", "Personal Satisfaction", "Persons", "Process", "Protocols documentation", "Public Health", "Race", "Research Activity", "Resource Allocation", "Risk", "Risk Assessment", "Sampling", "Siblings", "Speech Sound", "Stress", "Sum", "Support System", "Surveys", "Testing", "Time", "Toddler", "Transact", "Translations", "United States National Institutes of Health", "Validation", "Variant", "Visit", "base", "clinical practice", "cohort", "coronavirus disease", "design", "experience", "high risk", "innovation", "language impairment", "negative affect", "novel", "pandemic disease", "predictive modeling", "prevent", "protective effect", "recruit", "relating to nervous system", "sex", "social", "standard measure", "stress reduction", "translational approach", "tv watching", "visual tracking", "word learning" ], "approved": true } }, { "type": "Grant", "id": "6145", "attributes": { "award_id": "3R01HD094683-04S1", "title": "In Our Own Words: Peer-to-Peer Messaging to Increase Uptake of HIV Prevention Strategies among Adolescents in Kenya", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)" ], "program_reference_codes": [], "program_officials": [ { "id": 20879, "first_name": "Sonia S", "last_name": "Lee", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2017-09-12", "end_date": "2022-06-30", "award_amount": 199934, "principal_investigator": { "id": 20880, "first_name": "HONG-HA M", "last_name": "TRUONG", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [ { "id": 768, "ror": "https://ror.org/043mz5j54", "name": "University of California, San Francisco", "address": "", "city": "", "state": "CA", "zip": "", "country": "United States", "approved": true } ] }, "other_investigators": [], "awardee_organization": { "id": 768, "ror": "https://ror.org/043mz5j54", "name": "University of California, San Francisco", "address": "", "city": "", "state": "CA", "zip": "", "country": "United States", "approved": true }, "abstract": "– Original proposal Adolescents are at particularly high risk for HIV infection worldwide. In Kenya, there were an estimated 18,000 new infections among adolescents aged 15-19 years in 2015. The 2014 Kenya Demographic Health Survey revealed low levels of HIV knowledge and high levels of risk behavior among adolescent girls aged 15-19 years. These recent data highlight the importance of developing interventions that resonate with adolescents in order to reduce the number of new HIV infections in this priority population. When adolescents are given agency to create a narrative that reflects what is salient to them, the creative process may increase their knowledge and the resulting prevention messages are more likely to resonate with their peers. The proposed study will leverage the cultural importance of role play and live theater in Kenya to inform the development ofpublic service announcement (PSA) creation workshops for adolescent girls in Kisumu County to increase HIV knowledge and decrease risk behaviors among their peers. The specific aims are: 1) elicit adolescents' narratives regarding sexual health and HIV prevention, as voiced to peers; 2) characterize determinants shaping adolescents' mental and behavioral HIV prevention models; and 3) assess the feasibility and acceptability of HIV prevention PSA creation workshops. Our mixed-methods study integrates well with existing HIV prevention programs in Kenya and will synergize with the planned roll-out of PrEP in this region.", "keywords": [ "AIDS prevention", "AIDS/HIV problem", "Adolescent", "African", "Age", "Behavior", "Behavioral", "Car Phone", "Cognitive", "Coitus", "Communication", "Communities", "Community Health", "Country", "County", "Cross-Sectional Studies", "Data", "Decision Making", "Demographic and Health Surveys", "Development", "Diagnosis", "Educational workshop", "Emotional", "Epidemic", "Female Adolescents", "Film", "Focus Groups", "Future", "Generations", "Goals", "HIV", "HIV Infections", "Health Campaign", "Infection", "Intervention", "Interview", "Kenya", "Knowledge", "Linguistics", "Measures", "Mediation", "Methods", "Mind", "Modeling", "Participant", "Play", "Population", "Prevention", "Prevention program", "Prevention strategy", "Process", "Protocols documentation", "Psyche structure", "Reporting", "Respondent", "Risk Behaviors", "Role", "Sampling", "Secure", "Services", "Sexual Health", "Shapes", "Surveys", "Training", "Violence", "Voice", "Work", "acceptability and feasibility", "age group", "aged", "base", "biobehavior", "encryption", "experience", "girls", "high risk", "impression", "improved", "informant", "innovation", "knowledge of results", "peer", "pre-exposure prophylaxis", "prevention service", "recruit", "reproductive", "response", "sex", "sexually active", "stem", "trend", "uptake", "willingness" ], "approved": true } }, { "type": "Grant", "id": "6940", "attributes": { "award_id": "5P30AI050410-25", "title": "NC Collaborative HIV Epidemiology and Prevention (NC-CHEP) SWG", "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": "2001-08-20", "end_date": "2026-05-31", "award_amount": 55310, "principal_investigator": { "id": 22788, "first_name": "Christopher Browning", "last_name": "Hurt", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [ { "id": 817, "ror": "", "name": "UNIV OF NORTH CAROLINA CHAPEL HILL", "address": "", "city": "", "state": "NC", "zip": "", "country": "United States", "approved": true } ] }, "other_investigators": [], "awardee_organization": { "id": 817, "ror": "", "name": "UNIV OF NORTH CAROLINA CHAPEL HILL", "address": "", "city": "", "state": "NC", "zip": "", "country": "United States", "approved": true }, "abstract": "– NC-CHEP SWG Despite a robust toolkit of prevention and treatment options, HIV incidence in the US stubbornly remains around 39,000 cases per year. The reasons for this sustained, endemic spread of HIV are complex and interconnected, making it an inherently challenging area of scholarship whose success depends on team science, interdisciplinary approaches. It is precisely this kind of dynamic research environment that CFAR Scientific Working Groups (SWGs) are designed for, and the UNC CFAR will promote research supporting Ending the HIV Epidemic efforts through its North Carolina (NC) Collaborative HIV Epidemiology and Prevention (CHEP) SWG. This team builds upon the long-standing partnership between UNC CFAR consortium partners and the NC Department of Health and Human Services (DHHS), applying epidemiological data at the intersection of biomedical and social sciences. The NC-CHEP SWG will bring together experts across disciplines and investigators new to HIV to share ideas and approaches, with the goal of fostering an academic environment conducive to thinking “outside the box.” Under a conceptual framework acknowledging the interconnected social, ecological, and clinical realities of HIV prevention and care, the NC-CHEP SWG aims to: (1) develop and refine resources for characterizing and exploring the HIV prevention and care continuum; (2) sponsor and support activities to bring together intra- and extramural expertise on basic, social, implementation, and prevention science to share perspectives and develop research ideas; and (3) identify, recruit, and mentor new and early career HIV investigators, highlighting the unique intersections among social science, basic science, and medicine within the HIV field. To achieve these aims, the NC-CHEP SWG will: (1) update and curate a SWG membership directory and place it online; (2) meet with NC DHHS personnel to understand available data, any interval changes, and how to continue successfully working with NC DHHS data scientists and epidemiologists for data sharing; (3) work with the Clinical Core to expand the number of HIV-uninfected, at-risk individuals represented in the UNC CFAR HIV Clinical Cohort database; (4) initiate and direct work to characterize the prevention and care continuum in the context of the COVID-19 pandemic; (5) offer consistent, regularly scheduled programming with physical and virtual options to help members stay abreast of the “state of the science” in treatment and biomedical HIV prevention; (6) promote high-quality research ideas based on team science approaches through face-to-face and digital (asynchronous) peer review; (7) work with key faculty at UNC and our partners at historically Black colleges and universities to promote HIV science as a career path; and (8) increase the reach of the SWG members for disseminating their research by partnering with the state’s AIDS Education and Training Center to host webinars, work-in-progress talks, and virtual symposia.", "keywords": [ "AIDS education", "AIDS prevention", "Acquired Immunodeficiency Syndrome", "Area", "Awareness", "Basic Science", "Behavioral", "Biology", "COVID-19 pandemic", "Career Choice", "Caring", "Clinical", "Clinical Sciences", "Collaborations", "Complex", "Concept Review", "Continuity of Patient Care", "Data", "Data Scientist", "Databases", "Development", "Diagnosis", "Directories", "Discipline", "Environment", "Epidemic", "Epidemiologist", "Epidemiology", "Extramural Activities", "Faculty", "Fostering", "Funding", "Funding Opportunities", "Goals", "HIV", "HIV Seropositivity", "HIV risk", "Healthcare", "Historically Black Colleges and Universities", "Human Resources", "Incidence", "Individual", "Investments", "Manuscripts", "Marriage", "Medicine", "Mentors", "Mentorship", "North Carolina", "Peer Review", "Perception", "Persons", "Pharmaceutical Preparations", "Play", "Prevention", "Provider", "Public Health", "Publications", "Research", "Research Personnel", "Research Support", "Resources", "Risk", "Role", "Safety", "Schedule", "Scholarship", "Science", "Scientific Advances and Accomplishments", "Site", "Social Sciences", "South Carolina", "Strategic Planning", "Technology", "Testing", "Training and Education", "Translating", "United States", "United States Dept. of Health and Human Services", "United States National Institutes of Health", "Universities", "Update", "Viral Load result", "Virus", "Work", "acute infection", "antiretroviral therapy", "base", "career", "cohort", "comparative", "cost", "data sharing", "design", "digital", "epidemiologic data", "health literacy", "implementation science", "improved", "interdisciplinary approach", "member", "new technology", "pre-exposure prophylaxis", "preventive intervention", "recruit", "scale up", "service delivery", "social", "social stigma", "success", "symposium", "tool", "transmission process", "virtual", "webinar", "working group" ], "approved": true } }, { "type": "Grant", "id": "15418", "attributes": { "award_id": "1R01HL175474-01", "title": "Non-conventional signaling by α5 integrin in blood and endothelial cells", "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": 22468, "first_name": "Deborah", "last_name": "Philp", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2024-07-15", "end_date": "2028-06-30", "award_amount": 718854, "principal_investigator": { "id": 32027, "first_name": "Jieqing", "last_name": "Zhu", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [], "awardee_organization": { "id": 1016, "ror": "", "name": "VERSITI WISCONSIN, INC.", "address": "", "city": "", "state": "WI", "zip": "", "country": "United States", "approved": true }, "abstract": "– Integrins interact with their ligands to induce intracellular signals that mediate cellular activities such as cell adhesion, spreading, and migration, which are the essential cellular activities for the function of blood and endothelial cells. These signaling events are typically mediated by the cytoplasmic tail of integrin β subunit, while the role of α integrin cytoplasmic tail in integrin function remains relatively underexplored. Our research found that the fibronectin receptor integrin α5β1, via its α cytoplasmic tail, is involved in the formation of tunneling nanotubes (TNTs), a novel type of cellular structure for cell-to-cell communication. Remarkably, our research found that the α5β1-mediated TNT formation can be induced by the spike protein of coronavirus SARS- CoV-2. We observed the spike-induced and α5-dependent TNT formation in model cell lines and primary human blood and endothelial cells. Furthermore, we found that α5β1 integrin can mediate the spike-induced proinflammatory response in human blood and endothelial cells, which may contribute to the thrombotic events in COVID-19. TNTs are long actin-rich cell membrane protrusions that have been increasingly recognized as functional subcellular structures for long-distance dynamic intercellular connection. Functioning as conduits between connected cells, TNTs can transport cytoplasmic components like small molecules, proteins, vesicles, and mitochondria intercellularly. Accumulating evidence suggests that TNTs are involved in the progress of many pathological conditions such as cancer, inflammation, and neurodegenerative diseases. Bacteria and virus pathogens also exploit TNTs for cell-to-cell transmission. TNTs can form under cell stress conditions such as inflammation and virus infection. However, the cellular mechanisms regulating TNT formation remain largely unknown. This is mainly because little to nothing is known about the cell surface receptors directly responsible for TNT biogenesis. Our discovery of α5β1 integrin as a functional signaling receptor for TNT formation provides a powerful platform for investigating TNT biology. Mechanistically, we found that both α5β1-mediated TNT formation and proinflammatory response require the participation of α5 cytoplasmic tail, suggesting that these two processes are interconnected events. Moreover, our protein interaction data suggest a direct binding between α5β1 and the spike protein, which is independent of the classical integrin recognition Arg-Gly-Asp (RGD) motif. Based on these promising data, this application aims to elucidate the cellular mechanisms governing the non-conventional signaling function of α5β1 integrin in TNT formation and inflammation in blood and endothelial cells. Multifaced biochemical, biophysical, structural and cell biology approaches will be used to identify intracellular molecules and signaling pathways involved in the α5β1-mediated TNT formation (Aim 1) and inflammation (Aim 2) and to characterize the non-RGD dependent α5β1 and ligand interaction (Aim 3). The outcome of this study will advance both integrin and TNT biology and uncover potential therapeutic targets for modulating TNTs and inflammation in various diseases.", "keywords": [], "approved": true } }, { "type": "Grant", "id": "5738", "attributes": { "award_id": "3U01AG022308-18S1", "title": "Interventions that Retard Mammalian Aging", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Institute on Aging (NIA)" ], "program_reference_codes": [], "program_officials": [ { "id": 19780, "first_name": "Tiziana Paola", "last_name": "Cogliati", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2003-04-15", "end_date": "2024-03-31", "award_amount": 121763, "principal_investigator": { "id": 19781, "first_name": "DAVID E", "last_name": "HARRISON", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [ { "id": 19782, "first_name": "Nadia A", "last_name": "Rosenthal", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "awardee_organization": { "id": 873, "ror": "https://ror.org/021sy4w91", "name": "Jackson Laboratory", "address": "", "city": "", "state": "ME", "zip": "", "country": "United States", "approved": true }, "abstract": "– from funded parent award Identification of small molecules that extend mouse lifespan provides new insights into mechanisms of longevity determination in mammals, and may lay the groundwork for eventual anti-aging therapies in humans. The NIA Interventions Testing Program (ITP) evaluates agents proposed to extend mouse lifespan by retarding aging or postponing late life diseases. Interventions proposed by multiple collaborating scientists from the research community are tested, in parallel, at three sites (The Jackson Laboratory, University of Michigan and University of Texas), using identical, standardized protocols. Sufficient numbers of genetically heterogeneous mice are used to provide 80% power for detecting a 10% change in lifespan of either sex, after pooling data from any two of the test sites. Seventy-two such lifespan experiments, involving various doses of 44 distinct agents, have been initiated in the first fifteen years of the ITP. Thirty-seven experiments have involved comparative tests of multiple doses of effective agents, variable starting ages, or alternative dosing schedules. Significant effects on longevity, in one or both sexes, have been documented and then confirmed for NDGA, rapamycin, acarbose, and 17-α-estradiol (17aE2), with significant (but currently unconfirmed) effects also noted for Protandim, glycine and, in an interim analysis, canagliflozin. Lifespan trials are now underway for 18 new agents. ITP survival results have also documented longevity benefits from three agents started in middle- age: rapamycin, acarbose, and 17aE2. The previous five-year period has introduced three new features to the ITP: 1) increased emphasis on health outcomes (functional tests relevant to human health not necessarily linked to lifespan); 2) a Collaborative Interactions Program to provide tissues from ITP drug-treated mice to a growing, international network of scientific collaborators; and, 3) a publicly accessible data repository and display engine hosted by the Mouse Phenome Database at The Jackson Laboratory. Plans for the next five- year period include additional lifespan (\"Stage I\") trials, detailed analyses (\"Stage II\") of agents found to increase lifespan, continued growth in data on health outcomes, and collaborative work with scientists to study drug effects on postulated aging mechanisms and links to disease. Studies at The Jackson Laboratory will follow a wide variety of health outcomes measured with minimal stress, add more cognitive function tests, add longitudinal analyses, and study successful interventions in mouse models of aging diseases such as diabetes and dementia. The work proposed should allow the ITP to continue to make major contributions to mammalian aging biology.", "keywords": [ "2019-nCoV", "Acarbose", "Age", "Aging", "Animals", "Antibodies", "Antibody Formation", "Antibody Response", "Antigens", "Antiviral Agents", "Award", "Biological Assay", "Biology of Aging", "Blood", "CD8-Positive T-Lymphocytes", "COVID-19", "COVID-19 mortality", "Cells", "Cessation of life", "Chronic Obstructive Airway Disease", "Clinic", "Clinical Treatment", "Combination Drug Therapy", "Combined Modality Therapy", "Communities", "Cytokine Signaling", "Data", "Data Display", "Data Pooling", "Databases", "Dementia", "Diabetes Mellitus", "Disease", "Dose", "Drug Combinations", "Effectiveness", "Elderly", "Enzyme-Linked Immunosorbent Assay", "Equilibrium", "Estradiol", "Fibrosis", "Flow Cytometry", "Funding", "Glycine", "Growth", "Health", "Health Benefit", "Heterogeneity", "Human", "Immune", "Immune response", "Immunization", "Immunize", "Immunoglobulin G", "Immunoglobulin M", "Immunoglobulins", "Immunology", "Individual", "Inflammation", "Inflammatory", "Influenza", "Inhalation", "International", "Intervention", "Lead", "Link", "Longevity", "Lung", "Mammals", "Measures", "Metformin", "Michigan", "Modeling", "Morbidity - disease rate", "Mus", "Mutate", "Mutation", "Natural Immunity", "New Agents", "Outcome", "Outcome Measure", "Parents", "Patients", "Pharmaceutical Preparations", "Pharmacotherapy", "Phenotype", "Pneumonia", "Poly I-C", "Population", "Production", "Property", "Proteins", "Protocols documentation", "Public Health", "Research", "Risk Factors", "SARS-CoV-2 antigen", "Schedule", "Scientist", "Sirolimus", "Site", "Standardization", "Stress", "T-Lymphocyte", "Testing", "Texas", "The Jackson Laboratory", "Tissues", "Universities", "Vaccination", "Vaccines", "Viral", "Viral Antibodies", "Virus", "Virus Diseases", "Work", "adaptive immunity", "anti aging", "antiviral immunity", "body system", "cognitive function", "comparative", "cytokine", "cytokine release syndrome", "data repository", "experimental study", "healthspan", "high dimensionality", "high risk", "human model", "immune resistance", "improved", "infection risk", "insight", "longitudinal analysis", "middle age", "mortality", "mouse model", "older patient", "pandemic disease", "phenome", "prevent", "programs", "protective effect", "response", "sex", "small molecule", "successful intervention", "therapy design" ], "approved": true } }, { "type": "Grant", "id": "10671", "attributes": { "award_id": "1U01IP001194-01", "title": "RFA-IP-22-004, US Platform to Measure Effectiveness of Seasonal Influenza, COVID-19 and other Respiratory Virus Vaccines for the Prevention of Acute Illness in Ambulatory Settings", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [], "program_reference_codes": [], "program_officials": [], "start_date": "2022-09-30", "end_date": "2027-09-29", "award_amount": 987989, "principal_investigator": { "id": 26731, "first_name": "EMMANUEL B", "last_name": "WALTER", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [], "awardee_organization": { "id": 246, "ror": "https://ror.org/00py81415", "name": "Duke University", "address": "", "city": "", "state": "NC", "zip": "", "country": "United States", "approved": true }, "abstract": "– Duke Human Vaccine Institute Duke University is pleased to respond to RFA-IP-22-004 entitled “US Platform to Measure the Effectiveness of Seasonal Influenza, COVID-19 and other Respiratory Virus Vaccines for the Prevention of Acute Illness in Ambulatory Settings” by submitting the application for Component B. Duke University will coordinate the activities of the Centers for Disease Control and Prevention’s Respiratory Virus Vaccine Effectiveness Network incorporating the collective breadth of scientific, program management, regulatory, data management, statistical, and information technology expertise of the Duke Human Vaccine Institute (DHVI). In particular, we will leverage our vast prior experience coordinating clinical investigations for both NIAID and the CDC to help facilitate the work of this project. The Duke Network Coordinating Center (NCC) will provide logistical and coordinating support by facilitating network communications through hosting video and in-person conferences, hosting a network SharePoint, providing reports and project updates and establishing a clear communication plan for network activities. As the NCC, The DHVI will help facilitate protocol development and establish standard operating procedures for network investigations. Studies will include evaluations of both influenza and SARS-CoV-2 vaccine effectiveness at preventing symptomatic respiratory infection in the community and household settings. As the NCC, the DHVI is also well poised to support network studies assessing vaccine immunogenicity in addition to studies using more complex virologic and immunologic influenza assays to detect influenza virus infection and the host immune response to infection. Working with the Duke University Health System IRB, the Duke NCC will provide the regulatory support to facilitate single IRB requirements. Through our established quality management programs, we will also assure that network studies are performed in a manner which adhere to good clinical practice. The Duke NCC will provide data management and statistical support for network studies. Duke will build and host project specific REDCap databases from which information can be readily exported to provide project updates through dashboards. Data exports will also be utilized to create reports, presentations and manuscripts to disseminate information regarding the current effectiveness of the respiratory virus vaccine being evaluated given the circulating virus strains or variants.", "keywords": [], "approved": true } } ], "meta": { "pagination": { "page": 4, "pages": 1419, "count": 14184 } } }