Grant List
Represents Grant table in the DB
GET /v1/grants?page%5Bnumber%5D=1383&sort=other_investigators
{ "links": { "first": "https://cic-apps.datascience.columbia.edu/v1/grants?page%5Bnumber%5D=1&sort=other_investigators", "last": "https://cic-apps.datascience.columbia.edu/v1/grants?page%5Bnumber%5D=1424&sort=other_investigators", "next": "https://cic-apps.datascience.columbia.edu/v1/grants?page%5Bnumber%5D=1384&sort=other_investigators", "prev": "https://cic-apps.datascience.columbia.edu/v1/grants?page%5Bnumber%5D=1382&sort=other_investigators" }, "data": [ { "type": "Grant", "id": "7651", "attributes": { "award_id": "1R01MD016026-01", "title": "Reducing Racial Disparities in SMM post COVID19: Assessing the integration of maternal safety bundles and community based doulas to improve outcomes for Black women", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Institute on Minority Health and Health Disparities (NIMHD)" ], "program_reference_codes": [], "program_officials": [ { "id": 6437, "first_name": "Rada K", "last_name": "Dagher", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2020-09-17", "end_date": "2025-06-30", "award_amount": 717913, "principal_investigator": { "id": 23456, "first_name": "NDIDIAMAKA", "last_name": "AMUTAH-ONUKAGHA", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [ { "id": 863, "ror": "", "name": "TUFTS UNIVERSITY BOSTON", "address": "", "city": "", "state": "MA", "zip": "", "country": "United States", "approved": true } ] }, "other_investigators": [ { "id": 22627, "first_name": "Hafsatou", "last_name": "Diop", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [ { "id": 1517, "ror": "", "name": "MASSACHUSETTS STATE DEPT OF PUB HEALTH", "address": "", "city": "", "state": "MA", "zip": "", "country": "United States", "approved": true } ] }, { "id": 23457, "first_name": "EUGENE R", "last_name": "DECLERCQ", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "awardee_organization": { "id": 863, "ror": "", "name": "TUFTS UNIVERSITY BOSTON", "address": "", "city": "", "state": "MA", "zip": "", "country": "United States", "approved": true }, "abstract": "(Project Summary) Black women experience stark disparities in pregnancy care, complications, and outcomes, compared to White women. Recognizing, tracking and understanding patterns of severe maternal mortality (SMM) and associated inequities by race/ethnicity, along with developing and carrying out interventions to improve the quality of maternal care, are essential to reducing SMM and thereby maternal mortality. To date, there has been little research specifically aimed at understanding whether the maternal health inequities as experienced by Black women can be ameliorated through an integrated care model that includes engagement of mothers of color in the planning and implementation of maternal safety bundles in addition to prenatal, birth and postpartum support from community doulas. We intend to use the Health Impact Pyramid to develop, implement and assess the effectiveness of such a system in reducing disparities in SMM and mortality. The data sources for this study will include state-level and hospital-specific discharge data collected as part of the Alliance for Innovation on Maternal Health (AIM) project; the Maternal Mortality Review Committee (MMRC); and the Pregnancy to Early Life Longitudinal (PELL) data system, which focuses on population-level data needed to examine health inequities among racial and ethnic minorities in Massachusetts. In addition to these existing data sources, we intend to establish a data collection tool to assess doula services as well as analyze qualitative data from interviews with black women, and focus groups with providers and doulas to explore the effect of incorporating doula-provided services into prenatal, birth and postpartum care. This proposal has three main study areas that will lead to a systematic understanding of ways to address and prevent SMM among black women and thus, establish a foundation for the development, testing and scale-up of future interventions to improve maternal health outcomes: 1) Use longitudinally linked hospital discharge data from PELL (2008-2018) to characterize preconception, prenatal and postpartum hospital encounters among women with SMM in order to identify key points where opportunities to intervene were missed. 2): Among hospitals that serve black women, to assess the impact of implementing maternal safety bundles to ensure that black women are receiving quality obstetric care 3): Examine how systems integrating community-based doula support could decrease the inequities of SMM among black and white mothers. Our study will lead to a more systematic understanding of pregnancy outcomes for Black women at highest risk of SMM, thus establishing a foundation for development and testing of future interventions to improve maternal outcomes.", "keywords": [ "Address", "Area", "Attitude", "Biological", "Birth", "COVID-19", "Caring", "Centers for Disease Control and Prevention (U.S.)", "Color", "Communities", "Data", "Data Collection", "Data Linkages", "Data Sources", "Development", "Discipline of obstetrics", "Effectiveness", "Ensure", "Ethnic Origin", "Ethnic group", "Focus Groups", "Foundations", "Future", "Health", "Health Personnel", "Hemorrhage", "High Prevalence", "High Risk Woman", "Hispanics", "Hospitalization", "Hospitals", "Hybrids", "Hypertension", "Individual", "Information Systems", "Intervention", "Interview", "Investigation", "Life", "Link", "Live Birth", "Massachusetts", "Maternal Health", "Maternal Mortality", "Medical Care Team", "Methods", "Modeling", "Morbidity - disease rate", "Mothers", "Not Hispanic or Latino", "Outcome", "Pattern", "Perinatal Care", "Population", "Postpartum Period", "Pregnancy", "Pregnancy Complications", "Pregnancy Outcome", "Prenatal care", "Process", "Provider", "Public Health", "Race", "Recommendation", "Reporting", "Research", "Review Committee", "Risk", "Safety", "Services", "System", "Testing", "Time", "United States", "Woman", "Women&apos", "s Group", "Women&apos", "s Health", "base", "design", "disparity reduction", "ethnic minority population", "experience", "health care service utilization", "health disparity", "implementation science", "improved", "improved outcome", "innovation", "longitudinal design", "maternal outcome", "mortality", "mortality disparity", "obstetric care", "peer", "postpartum care", "prenatal", "prevent", "preventable death", "programs", "racial disparity", "racial minority", "scale up", "secondary analysis", "severe maternal morbidity", "tool" ], "approved": true } }, { "type": "Grant", "id": "8981", "attributes": { "award_id": "5R01MD016026-02", "title": "Reducing Racial Disparities in SMM post COVID19: Assessing the integration of maternal safety bundles and community based doulas to improve outcomes for Black women", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Institute on Minority Health and Health Disparities (NIMHD)" ], "program_reference_codes": [], "program_officials": [ { "id": 6437, "first_name": "Rada K", "last_name": "Dagher", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2020-09-17", "end_date": "2025-06-30", "award_amount": 630060, "principal_investigator": { "id": 23456, "first_name": "NDIDIAMAKA", "last_name": "AMUTAH-ONUKAGHA", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [ { "id": 863, "ror": "", "name": "TUFTS UNIVERSITY BOSTON", "address": "", "city": "", "state": "MA", "zip": "", "country": "United States", "approved": true } ] }, "other_investigators": [ { "id": 22627, "first_name": "Hafsatou", "last_name": "Diop", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [ { "id": 1517, "ror": "", "name": "MASSACHUSETTS STATE DEPT OF PUB HEALTH", "address": "", "city": "", "state": "MA", "zip": "", "country": "United States", "approved": true } ] }, { "id": 23457, "first_name": "EUGENE R", "last_name": "DECLERCQ", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "awardee_organization": { "id": 863, "ror": "", "name": "TUFTS UNIVERSITY BOSTON", "address": "", "city": "", "state": "MA", "zip": "", "country": "United States", "approved": true }, "abstract": "(Project Summary) Black women experience stark disparities in pregnancy care, complications, and outcomes, compared to White women. Recognizing, tracking and understanding patterns of severe maternal mortality (SMM) and associated inequities by race/ethnicity, along with developing and carrying out interventions to improve the quality of maternal care, are essential to reducing SMM and thereby maternal mortality. To date, there has been little research specifically aimed at understanding whether the maternal health inequities as experienced by Black women can be ameliorated through an integrated care model that includes engagement of mothers of color in the planning and implementation of maternal safety bundles in addition to prenatal, birth and postpartum support from community doulas. We intend to use the Health Impact Pyramid to develop, implement and assess the effectiveness of such a system in reducing disparities in SMM and mortality. The data sources for this study will include state-level and hospital-specific discharge data collected as part of the Alliance for Innovation on Maternal Health (AIM) project; the Maternal Mortality Review Committee (MMRC); and the Pregnancy to Early Life Longitudinal (PELL) data system, which focuses on population-level data needed to examine health inequities among racial and ethnic minorities in Massachusetts. In addition to these existing data sources, we intend to establish a data collection tool to assess doula services as well as analyze qualitative data from interviews with black women, and focus groups with providers and doulas to explore the effect of incorporating doula-provided services into prenatal, birth and postpartum care. This proposal has three main study areas that will lead to a systematic understanding of ways to address and prevent SMM among black women and thus, establish a foundation for the development, testing and scale-up of future interventions to improve maternal health outcomes: 1) Use longitudinally linked hospital discharge data from PELL (2008-2018) to characterize preconception, prenatal and postpartum hospital encounters among women with SMM in order to identify key points where opportunities to intervene were missed. 2): Among hospitals that serve black women, to assess the impact of implementing maternal safety bundles to ensure that black women are receiving quality obstetric care 3): Examine how systems integrating community-based doula support could decrease the inequities of SMM among black and white mothers. Our study will lead to a more systematic understanding of pregnancy outcomes for Black women at highest risk of SMM, thus establishing a foundation for development and testing of future interventions to improve maternal outcomes.", "keywords": [ "Address", "Area", "Attitude", "Biological", "Birth", "COVID-19", "Caring", "Centers for Disease Control and Prevention (U.S.)", "Color", "Communities", "Data", "Data Collection", "Data Linkages", "Data Sources", "Development", "Discipline of obstetrics", "Ensure", "Ethnic Origin", "Ethnic group", "Focus Groups", "Foundations", "Future", "Health", "Health Personnel", "Hemorrhage", "High Prevalence", "High Risk Woman", "Hispanics", "Hospitalization", "Hospitals", "Hypertension", "Individual", "Information Systems", "Intervention", "Interview", "Investigation", "Life", "Link", "Live Birth", "Massachusetts", "Maternal Health", "Maternal Mortality", "Medical Care Team", "Methods", "Modeling", "Morbidity - disease rate", "Mothers", "Not Hispanic or Latino", "Outcome", "Pattern", "Perinatal Care", "Population", "Postpartum Period", "Pregnancy", "Pregnancy Complications", "Pregnancy Outcome", "Prenatal care", "Provider", "Public Health", "Race", "Recommendation", "Reporting", "Research", "Review Committee", "Risk", "Services", "System", "Testing", "Time", "United States", "Woman", "Women&apos", "s Group", "Women&apos", "s Health", "base", "black women", "design", "disparity reduction", "effectiveness evaluation", "ethnic minority population", "experience", "health care service utilization", "health disparity", "health inequalities", "hybrid type 1 trial", "implementation framework", "implementation outcomes", "implementation process", "implementation science", "improved", "improved outcome", "innovation", "longitudinal design", "maternal outcome", "maternal safety", "mortality", "mortality disparity", "obstetric care", "peer", "postpartum care", "prenatal", "prevent", "preventable death", "programs", "racial disparity", "racial minority", "scale up", "secondary analysis", "severe maternal morbidity", "tool" ], "approved": true } }, { "type": "Grant", "id": "6811", "attributes": { "award_id": "1R01AR080356-01", "title": "Evaluating Clinical and Immunological Consequences of SARS-CoV-2 Vaccination in Rheumatic Disease", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)" ], "program_reference_codes": [], "program_officials": [ { "id": 22629, "first_name": "Yan Z.", "last_name": "Wang", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2021-12-01", "end_date": "2024-11-30", "award_amount": 207958, "principal_investigator": { "id": 22630, "first_name": "DANA P", "last_name": "ASCHERMAN", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [ { "id": 848, "ror": "", "name": "UNIVERSITY OF PITTSBURGH AT PITTSBURGH", "address": "", "city": "", "state": "PA", "zip": "", "country": "United States", "approved": true } ] }, "other_investigators": [ { "id": 22631, "first_name": "Robyn Therese", "last_name": "Domsic", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "awardee_organization": { "id": 848, "ror": "", "name": "UNIVERSITY OF PITTSBURGH AT PITTSBURGH", "address": "", "city": "", "state": "PA", "zip": "", "country": "United States", "approved": true }, "abstract": "The current SARS-CoV-2 pandemic has had devastating consequences, with more than 110,000,000 cases and 2,400,000 deaths worldwide. Beyond the direct effects of SARS-CoV-2 infection, much of the morbidity and mortality stems from dysregulated activation of the immune system that culminates in systemic manifestations ranging from cytokine storm to autoimmunity. Recent work suggests that the basis for observed autoimmune complications of SARS-CoV-2 infection resides in the high degree of sequence overlap between viral proteins and native tissue antigens. Given this sequence overlap and the potential for molecular mimicry/induction of autoimmunity in the setting of SARS-CoV-2 infection, there is concern that vaccines geared towards the generation of protective immune responses against the SARS-CoV-2 spike protein may increase the risk of autoreactivity—particularly in patients with pre-existing autoimmune disease and associated immune dysregulation. Because patients with underlying autoimmune diseases such as idiopathic inflammatory myopathy, systemic sclerosis, rheumatoid arthritis, and primary Sjogren’s syndrome were not included in the original trials of vaccines targeting the SARS-CoV-2 spike protein, there is a clear unmet need to better understand the consequences of SARS-CoV-2 vaccination in these patient populations—both in terms of vaccine response as well as the potential for disease exacerbation/development of de novo autoimmune manifestations. Coupled with our well-established, longitudinal rheumatic disease database/biorepository that includes an integrated data management system (RDMS=Rheumatic Disease Data Management System), our experience with the use of remote digital platforms and assessment of patient reported outcomes (PROs) makes us uniquely positioned to conduct successful observational studies of vaccine-induced clinical/immunological responses. To evaluate the relationship between changes in clinical disease activity and vaccine-induced autoreactivity, we have 3 specific aims. In Specific Aim 1, we will use general as well as disease-specific PROs at defined time points pre- and post-vaccination to assess changes in disease activity over a 12 month period—and compare these changes to pre-vaccination fluctuations in disease activity over a parallel time frame. In Specific Aim 2, we will apply novel, radiolabel-free methods of immunoprecipitation and Difference in Gel Electrophoresis to assess corresponding serum samples collected at pre- and post-vaccination time points and define vaccine- induced shifts in autoantibody profile as well as the development of anti-spike protein antibodies. In Specific Aim 3, we will use different statistical models to evaluate the relationship between these antibody profiles and changes in clinical disease activity/de novo autoimmune manifestations. Successful completion of these aims will directly address the existing knowledge gap surrounding vaccine responses in understudied rheumatic disease patient populations and establish a clinical cohort/biorepository that will serve as an unparalleled resource for biomarker development as well as future research in vaccine-associated immune alterations.", "keywords": [ "2019-nCoV", "Address", "Antibodies", "Antigens", "Antiviral Agents", "Antiviral Response", "Autoantibodies", "Autoimmune", "Autoimmune Diseases", "Autoimmune Responses", "Autoimmunity", "Biological Specimen database", "COVID-19 pandemic", "COVID-19 vaccination", "COVID-19 vaccine", "Cessation of life", "Clinical", "Coupled", "Data", "Data Management Resources", "Database Management Systems", "Detection", "Development", "Disease", "Disease susceptibility", "Feedback", "Generations", "Idiopathic Inflammatory Myopathies", "Immune", "Immune response", "Immune system", "Immunization Programs", "Immunologics", "Immunoprecipitation", "Infection", "Infrastructure", "Knowledge", "Link", "Literature", "Longitudinal cohort", "Measures", "Methods", "Modeling", "Molecular Mimicry", "Morbidity - disease rate", "Observational Study", "Online Systems", "Organ", "Outcome Measure", "Patient Outcomes Assessments", "Patients", "Peptides", "Pharmaceutical Preparations", "Physicians", "Population Control", "Positioning Attribute", "Price", "Prospective cohort", "Proteins", "Questionnaires", "Resources", "Rheumatism", "Rheumatoid Arthritis", "Risk", "SARS-CoV-2 infection", "SARS-CoV-2 spike protein", "Sampling", "Sequence Homology", "Serology", "Serum", "Sjogren&apos", "s Syndrome", "Specimen", "Statistical Models", "Suggestion", "Systemic Scleroderma", "Techniques", "Testing", "Therapeutic immunosuppression", "Time", "Tissues", "Universities", "Vaccinated", "Vaccination", "Vaccine Design", "Vaccines", "Viral Proteins", "Work", "adaptive immune response", "anti-tumor immune response", "autoinflammatory", "autoreactivity", "base", "biobank", "biomarker development", "cohort", "cross reactivity", "cytokine release syndrome", "design", "digital", "disorder control", "disorder risk", "experience", "gel electrophoresis", "immune activation", "insight", "mortality", "novel", "patient population", "radiotracer", "response", "side effect", "stem", "vaccine delivery", "vaccine development", "vaccine efficacy", "vaccine response", "vaccine trial" ], "approved": true } }, { "type": "Grant", "id": "6895", "attributes": { "award_id": "5U01AI069924-17", "title": "International epidemiology Databases to Evaluate AIDS (IeDEA) Southern Africa.", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Institute on Alcohol Abuse and Alcoholism (NIAAA)" ], "program_reference_codes": [], "program_officials": [ { "id": 10295, "first_name": "Lori B.", "last_name": "Zimand", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2006-07-01", "end_date": "2026-04-30", "award_amount": 3400000, "principal_investigator": { "id": 22641, "first_name": "Mary-Ann", "last_name": "Davies", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [ { "id": 1520, "ror": "", "name": "UNIVERSITAT BERN", "address": "", "city": "", "state": "", "zip": "", "country": "SWITZERLAND", "approved": true } ] }, "other_investigators": [ { "id": 22642, "first_name": "Matthias", "last_name": "Egger", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "awardee_organization": { "id": 1520, "ror": "", "name": "UNIVERSITAT BERN", "address": "", "city": "", "state": "", "zip": "", "country": "SWITZERLAND", "approved": true }, "abstract": "Southern Africa is the epicenter of the HIV and tuberculosis (TB) epidemic, and South Africa is at the center of the COVID-19 pandemic in Africa. There is an urgent need for robust epidemiology and implementation science to address the interacting burdens of HIV, TB, and other (emerging) coinfections and non-communicable diseases (NCDs). The International epidemiology Databases to Evaluate AIDS in Southern Africa (IeDEA-SA) has defined six specific aims for the fourth funding period (IeDEA-SA IV): (1) to study outcomes along the continuum of HIV care in adults; (2) to study outcomes in pregnant women, infants, children, and adolescents; (3) to study NCDs, hepatitis B and sexually transmitted infections (STIs); (4) to study the clinical and public health epidemiology of TB; (5) to study cancer prevention, burden, and care; and (6) to study mental health and substance use disorders. Further, we defined six cross-cutting themes: (i) the impact of the COVID-19 pandemic on health services; (ii) gender equity; (iii) capacity building; (iv) digital transformation; (v) open science; and (vi) the United Nations Sustainable Development Goals, which we will develop and prioritize within each aim. Innovations include the addition of the Western Cape Provincial Health Data Centre (WC PHDC), the South African HIV Cancer Match study, the establishment of pre-Exposure prophylaxis cohorts, and the evaluation of novel technologies (for example, a point-of-care genome-sequencing device, a hand-held colposcopic device for cervical cancer screening, or tools to study the transmission of TB in the health care setting) and novel statistical and mathematical modeling approaches. Multiregional Sentinel Research Networks (NCD-Sentinel Research Network [SRN], TB-SRN, Adolescent and Young Adult Network of IeDEA) on NCDs, TB, and adolescents and youth will harmonize data collection across the six IeDEA regions in low- and middle-income countries. The Fogarty-IeDEA Mentorship Program will strengthen capacity building among early-stage investigators. IeDEA-SA now follows nearly 1.3 million people living with HIV, including 285,000 individuals from the private sector (the Aid for AIDS program AfA), and 370,000 with ART duration > ten years. IeDEA IV will add data from 600,000 HIV-negative people through AfA and information from up to 4 million HIV-negative individuals from the WC PHDC in specific analyses. Within IeDEA, the Southern African region includes by far the largest number of adults and children. The COVID-19 pandemic now highlights the importance of epidemiologic research and implementation science across the health system. IeDEA-SA is well- placed to address the specific aims and cross-cutting themes outlined in this application, through its successful track-record of collaboration between the scientific and operational leadership at the Universities of Bern and Cape Town, partnership with several African universities (including the Kwazulu-Natal Research Innovation and Sequencing Platform), United States and European universities, and with the World Health Organization and the Joint United Nations Programme on HIV/AIDS.", "keywords": [ "2019-nCoV", "AIDS/HIV problem", "Acquired Immunodeficiency Syndrome", "Address", "Adolescent", "Adolescent and Young Adult", "Adult", "Adverse event", "Affect", "Africa", "Africa South of the Sahara", "African", "Anti-Retroviral Agents", "Breast Feeding", "COVID-19", "COVID-19 pandemic", "Caring", "Cervical Cancer Screening", "Child", "Clinical", "Collaborations", "Data", "Data Collection", "Data Linkages", "Databases", "Devices", "Diagnosis", "Diagnostic", "Disease", "Drug resistance", "Drug resistance in tuberculosis", "Epidemic", "Epidemiology", "European", "Evaluation", "Funding", "Goals", "HIV", "HIV Seronegativity", "HIV/TB", "Hand", "Health", "Health Services", "Health care facility", "Health system", "Hepatitis B", "Hepatitis B Virus", "Incidence", "Individual", "Infant", "Infection", "International", "Joints", "Leadership", "Life Cycle Stages", "Life Expectancy", "Liver", "Lung diseases", "Malignant Neoplasms", "Mental Health", "Mentorship", "Metabolic", "Methods", "Modeling", "Monitor", "Outcome", "Outcome Study", "Output", "Persons", "Pharmaceutical Preparations", "Policies", "Pregnant Women", "Prevalence Study", "Prevention", "Prevention program", "Prevention strategy", "Private Sector", "Public Health", "Pulmonary Tuberculosis", "Quality of life", "Regimen", "Registries", "Research", "Research Personnel", "Resistance", "Risk", "Risk Factors", "SARS-CoV-2 transmission", "Safety", "Sentinel", "Services", "Sexually Transmitted Diseases", "South Africa", "South African", "Southern Africa", "Sputum", "Statistical Models", "Substance Use Disorder", "Sustainable Development", "Time", "Translating", "Treatment outcome", "Tuberculosis", "United Nations", "United States", "Universities", "Viral", "Woman", "Work", "World Health Organization", "antiretroviral therapy", "base", "cancer care", "cancer diagnosis", "cancer health disparity", "cancer prevention", "cardiometabolic risk", "cervical cancer prevention", "co-infection", "cohort", "cost effective", "data centers", "data harmonization", "digital", "efavirenz", "epidemiology study", "gender equity", "genome sequencing", "health care settings", "health data", "implementation science", "improved", "improved outcome", "in utero", "innovation", "low and middle-income countries", "mathematical model", "mortality", "negative affect", "new technology", "novel", "open data", "point of care", "pre-exposure prophylaxis", "prevent", "programs", "resi" ], "approved": true } }, { "type": "Grant", "id": "6823", "attributes": { "award_id": "3UG1DA050071-04S1", "title": "Leveraging Social Networks to Increase COVID-19 Testing Uptake: A Comparison of Credible Messenger and Chain Referral Recruitment Approaches", "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": 21691, "first_name": "CARRIE FRIED", "last_name": "Mulford", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2019-07-15", "end_date": "2024-04-30", "award_amount": 210209, "principal_investigator": { "id": 21692, "first_name": "KATHERINE S", "last_name": "ELKINGTON", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [ { "id": 812, "ror": "", "name": "NEW YORK STATE PSYCHIATRIC INSTITUTE", "address": "", "city": "", "state": "NY", "zip": "", "country": "United States", "approved": true } ] }, "other_investigators": [ { "id": 20936, "first_name": "MILTON L", "last_name": "WAINBERG", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, { "id": 22646, "first_name": "Edward V.", "last_name": "Nunes", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "awardee_organization": { "id": 812, "ror": "", "name": "NEW YORK STATE PSYCHIATRIC INSTITUTE", "address": "", "city": "", "state": "NY", "zip": "", "country": "United States", "approved": true }, "abstract": "Until the advent of treatment or a vaccine, our ability to contain COVID-19 must rely on widespread identification of (asymptomatic) positive cases, their subsequent quarantine, and contact tracing of those potentially exposed. Therefore testing efforts must be targeted to those highly vulnerable yet unserved populations, including individuals who use opioids and other substances. These individuals may have poor respiratory or pulmonary health due to substance use (e.g. opioids, methamphetamine), which may make them more susceptible to the virus. Also, these individuals are also more likely to have been incarcerated, or reside on the street, in shelters or in crowded accommodation, further placing them at risk for transmission. We propose research to establish efficacy and sustainability of a community-social network outreach model that partners infectious disease health providers with community based organizations to successfully implement (reach, uptake, delivery and sustainment) COVID-19 point of service, rapid-testing among a highly vulnerable and often underserved population, those who use opioids and other substances. Two distinct social network recruitment strategies with demonstrated efficacy identifying hidden populations and increasing uptake of HIV testing will be adapted and compared. Guided by the EPIS framework, social cognitive theory, and Andersen’s model, this study comprises three phases. Phase 1: Adaptation of outreach recruitment strategies, we will work with our project community advisory board (CAB) to adapt chain-referral and credible messenger strategies for uptake of COVID-19 testing, to finalize recruitment and on-site testing protocols, and to train the CAB in the new protocols and in continuous quality improvement strategies (Aim 1). Phase 2: Strategy Efficacy Trial and Implementation Evaluation, we will compare the two strategies in a cross-over design at two community based organizations (CBOs) with long standing history of serving hard-to-reach populations in their communities. The comparison of strategies is not to identify the statistical superiority of one sampling strategy in providing population estimates over the other, but instead to identify the ability of each recruitment strategy to reach the target population and increase uptake of COVID-19 tests. We will examine the impact of each strategy on (i) reach (recruitment of target population), (ii) COVID-19 testing/repeat testing, and (iii) service delivery (i.e. quarantine, medical care and contact tracing) among those who test positive for COVID-19 (exploratory) (Aim 2). Phase 3: Sustainment, CBOs will implement the strategy proven efficacious based on outcomes, and we will examine their sustainment of the program (Aim 2). Implementation evaluation will identify participant-, staff-, and organizational-level factors that influence the feasibility, acceptability, and sustainability of each strategy in these CBOs. (Aim 3). This investigation will provide much needed information to improve health outcomes and to identify effective system-level responses to prevent or arrest the spread of COVID-19 among the social networks of those who use opioids and other substances, a highly vulnerable and often overlooked population.", "keywords": [ "AIDS prevention", "Address", "Affect", "COVID-19", "COVID-19 screening", "COVID-19 test", "COVID-19 testing", "Caring", "Communicable Diseases", "Communities", "Community Outreach", "Contact Tracing", "Crossover Design", "Crowding", "Data", "Disasters", "Education", "Elements", "Ensure", "Environment", "Epidemic", "Future", "HIV", "Health", "Health Personnel", "Health Services Accessibility", "Health behavior", "Health system", "Hepatitis C virus", "Hospitalization", "Human immunodeficiency virus test", "Imprisonment", "Individual", "Infrastructure", "Intervention", "Investigation", "Knowledge", "Medical", "Methamphetamine", "Modeling", "Neighborhoods", "Network-based", "New York City", "Opioid", "Outcome", "Ownership", "Participant", "Pharmaceutical Preparations", "Phase", "Population", "Poverty", "Prevention program", "Process", "Program Sustainability", "Protocols documentation", "Public Health", "Quarantine", "Recording of previous events", "Research", "Risk", "Risk Reduction", "SARS-CoV-2 positive", "Sampling", "Services", "Severities", "Shelter facility", "Site", "Social Network", "System", "Target Populations", "Technology", "Testing", "Time", "Training", "Underserved Population", "Vaccines", "Virus", "Vulnerable Populations", "Washington", "Work", "base", "behavior test", "community based participatory research", "comparative efficacy", "distrust", "economic determinant", "efficacy trial", "experience", "health care availability", "health care model", "high risk population", "implementation evaluation", "implementation strategy", "improved", "lung health", "member", "mortality", "novel", "novel strategies", "opioid use", "opioid user", "outreach", "pandemic disease", "peer", "peer support", "prevent", "psychosocial", "rapid testing", "recruit", "residence", "respiratory health", "response", "scale up", "screening", "service delivery", "social cognitive theory", "social stigma", "socioeconomics", "substance use", "testing uptake", "transmission process", "uptake" ], "approved": true } }, { "type": "Grant", "id": "11751", "attributes": { "award_id": "1R21AI178550-01", "title": "Pre-clinical evaluation of alpha-Cache; a novel RNA vaccine for an emerging orthobunyavirus", "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": 6817, "first_name": "Rodolfo M.", "last_name": "Alarcon", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2023-06-13", "end_date": "2025-05-31", "award_amount": 262294, "principal_investigator": { "id": 27626, "first_name": "Albert J.", "last_name": "Auguste", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [ { "id": 22647, "first_name": "Jesse Hong-Sae", "last_name": "Erasmus", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [ { "id": 1031, "ror": "", "name": "HDT BIO CORPORATION", "address": "", "city": "", "state": "WA", "zip": "", "country": "United States", "approved": true } ] } ], "awardee_organization": { "id": 839, "ror": "", "name": "VIRGINIA POLYTECHNIC INST AND ST UNIV", "address": "", "city": "", "state": "VA", "zip": "", "country": "United States", "approved": true }, "abstract": "Orthobunyaviruses are an understudied genus in the order Bunyavirales that has no vaccines or therapies in clinical development. One of the prototype pathogens within this genus, as recently identified by NIAID, is Cache Valley virus (CVV). CVV is an emerging arthropod-borne virus that induces spontaneous abortions and congenital malformations in ruminants and humans. Given CVV’s prevalence and its broad host range, coupled with the expanding geographical range of its diverse array of competent vectors, the epidemic potential of CVV continues to increase, reminiscent of what was previously observed for Chikungunya and Zika viruses. To date, there have been no reported vaccine development activities for this virus, and prototype approaches are urgently needed to develop road maps for vaccines against viruses within this genus should an epidemic occur in the future. With the rapid adoption of mRNA vaccine technology during the ongoing COVID-19 pandemic, coupled with the recent emergency use approval of HDT Bio’s self-amplifying mRNA vaccine platform, we propose to apply HDT’s technology to develop prototype vaccines for the orthobunyavirus genus with a proof-of-concept vaccine to prevent CVV infection in a novel murine model of CVV infection and disease. This innovative, timely, and critically important R21 aims to study the safety profile and protective efficacy of this vaccine, and identify the important antigens required for broad cross-reactive immunity post-vaccination, via two specific aims: 1. Evaluate the safety, immunogenicity, and optimal dosage regimen for a LIONTM-formulated, replicon- RNA vaccine for CVV. 2. Investigate the efficacy and correlates of protection of a LION-formulated, replicon-RNA vaccine for preventing CVV-induced disease in murine models. Considering a One Health approach, and recognizing the connection between the health of humans and animals, such a vaccine could have an immediate impact in the veterinary/agricultural market, simultaneously preventing economic damage, animal disease, and disease emergence in humans. In the event of epidemic emergence in humans, this approach could be rapidly adapted and scaled for human trials.", "keywords": [ "Adoption", "Advisory Committees", "Agriculture", "Animal Diseases", "Animals", "Antibodies", "Antigens", "Arboviruses", "Brazil", "Bunyavirales", "COVID-19 pandemic", "Cache Valley virus", "Case Study", "Categories", "Cessation of life", "Characteristics", "Chikungunya virus", "Chronic", "Clinical", "Clinical Trials", "Collaborations", "Congenital Abnormality", "Coupled", "Coupling", "Culicidae", "Disease", "Dose", "Economic Burden", "Economics", "Emergency Situation", "Encephalitis", "Epidemic", "Event", "Fatigue", "Fever", "Food", "Future", "Genus Phlebovirus", "Geographic Distribution", "Geography", "Goals", "Headache", "Health", "Health protection", "High Prevalence", "Human", "Immune response", "Immunity", "Immunization", "Immunocompetent", "Immunologist", "In Vitro", "Incidence", "India", "Induced Abortion", "Infant", "Infection", "Licensing", "Lipids", "Livestock", "Longevity", "Macrocephaly", "Maps", "Marketing", "Medical", "Meningitis", "Morbidity - disease rate", "Musculoskeletal System", "National Institute of Allergy and Infectious Disease", "Nausea", "Neurologic", "North America", "Orthobunyavirus", "Pathogenesis", "Phenotype", "Positioning Attribute", "Prevalence", "Prevention", "RNA", "RNA Viruses", "RNA vaccine", "Recording of previous events", "Regimen", "Replicon", "Reporting", "Resources", "Rift Valley fever virus", "Risk", "Role", "Ruminants", "Safety", "Seroprevalences", "South Korea", "Spontaneous abortion", "Study models", "System", "T cell response", "Technology", "Teratogens", "Testing", "United States National Institutes of Health", "Vaccination", "Vaccines", "Venezuelan Equine Encephalitis Virus", "Viral", "Viral Antigens", "Viral Pathogenesis", "Virus", "Virus Diseases", "Virus Replication", "Zika Virus", "Zoonoses", "burden of illness", "clinical development", "combat", "cross reactivity", "dosage", "enzootic", "epidemic potential", "epizootic", "future epidemic", "human pathogen", "immunogenic", "immunogenicity", "in vivo", "innovation", "member", "mortality", "mouse model", "nanoparticle", "novel", "pathogen", "preclinical development", "preclinical evaluation", "prevent", "protective efficacy", "prototype", "response", "safety study", "transmission process", "vaccine candidate", "vaccine development", "vaccine efficacy", "vaccine platform", "vaccine trial", "vaccinology", "vector" ], "approved": true } }, { "type": "Grant", "id": "15027", "attributes": { "award_id": "5R21AI178550-02", "title": "Pre-clinical evaluation of alpha-Cache; a novel RNA vaccine for an emerging orthobunyavirus", "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": 6817, "first_name": "Rodolfo M.", "last_name": "Alarcon", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2023-06-13", "end_date": "2025-05-31", "award_amount": 206342, "principal_investigator": { "id": 27626, "first_name": "Albert J.", "last_name": "Auguste", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [ { "id": 22647, "first_name": "Jesse Hong-Sae", "last_name": "Erasmus", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [ { "id": 1031, "ror": "", "name": "HDT BIO CORPORATION", "address": "", "city": "", "state": "WA", "zip": "", "country": "United States", "approved": true } ] } ], "awardee_organization": { "id": 839, "ror": "", "name": "VIRGINIA POLYTECHNIC INST AND ST UNIV", "address": "", "city": "", "state": "VA", "zip": "", "country": "United States", "approved": true }, "abstract": "Orthobunyaviruses are an understudied genus in the order Bunyavirales that has no vaccines or therapies in clinical development. One of the prototype pathogens within this genus, as recently identified by NIAID, is Cache Valley virus (CVV). CVV is an emerging arthropod-borne virus that induces spontaneous abortions and congenital malformations in ruminants and humans. Given CVV’s prevalence and its broad host range, coupled with the expanding geographical range of its diverse array of competent vectors, the epidemic potential of CVV continues to increase, reminiscent of what was previously observed for Chikungunya and Zika viruses. To date, there have been no reported vaccine development activities for this virus, and prototype approaches are urgently needed to develop road maps for vaccines against viruses within this genus should an epidemic occur in the future. With the rapid adoption of mRNA vaccine technology during the ongoing COVID-19 pandemic, coupled with the recent emergency use approval of HDT Bio’s self-amplifying mRNA vaccine platform, we propose to apply HDT’s technology to develop prototype vaccines for the orthobunyavirus genus with a proof-of-concept vaccine to prevent CVV infection in a novel murine model of CVV infection and disease. This innovative, timely, and critically important R21 aims to study the safety profile and protective efficacy of this vaccine, and identify the important antigens required for broad cross-reactive immunity post-vaccination, via two specific aims: 1. Evaluate the safety, immunogenicity, and optimal dosage regimen for a LIONTM-formulated, replicon- RNA vaccine for CVV. 2. Investigate the efficacy and correlates of protection of a LION-formulated, replicon-RNA vaccine for preventing CVV-induced disease in murine models. Considering a One Health approach, and recognizing the connection between the health of humans and animals, such a vaccine could have an immediate impact in the veterinary/agricultural market, simultaneously preventing economic damage, animal disease, and disease emergence in humans. In the event of epidemic emergence in humans, this approach could be rapidly adapted and scaled for human trials.", "keywords": [ "Adoption", "Advisory Committees", "Agriculture", "Animal Diseases", "Animals", "Antibodies", "Antigens", "Arboviruses", "Brazil", "Bunyavirales", "COVID-19 pandemic", "Cache Valley virus", "Case Study", "Categories", "Cessation of life", "Characteristics", "Chikungunya virus", "Chronic", "Clinical", "Clinical Trials", "Collaborations", "Congenital Abnormality", "Coupled", "Coupling", "Culicidae", "Disease", "Dose", "Economic Burden", "Economics", "Emergency Situation", "Encephalitis", "Epidemic", "Event", "Fatigue", "Fever", "Food", "Future", "Genus Phlebovirus", "Geographic Distribution", "Geography", "Goals", "Headache", "Health", "Health protection", "High Prevalence", "Human", "Immune response", "Immunity", "Immunization", "Immunocompetent", "Immunologist", "In Vitro", "Incidence", "India", "Induced Abortion", "Infant", "Infection", "Licensing", "Lipids", "Livestock", "Longevity", "Macrocephaly", "Maps", "Marketing", "Medical", "Meningitis", "Morbidity - disease rate", "Musculoskeletal System", "National Institute of Allergy and Infectious Disease", "Nausea", "Neurologic", "North America", "Orthobunyavirus", "Pathogenesis", "Phenotype", "Positioning Attribute", "Prevalence", "Prevention", "RNA", "RNA Viruses", "RNA vaccine", "Recording of previous events", "Regimen", "Replicon", "Reporting", "Resources", "Rift Valley fever virus", "Risk", "Role", "Ruminants", "Safety", "Seroprevalences", "South Korea", "Spontaneous abortion", "Study models", "System", "T cell response", "Technology", "Teratogens", "Testing", "United States National Institutes of Health", "Vaccination", "Vaccines", "Venezuelan Equine Encephalitis Virus", "Viral", "Viral Antigens", "Viral Pathogenesis", "Virus", "Virus Diseases", "Virus Replication", "Zika Virus", "Zoonoses", "arthropod-borne", "burden of illness", "clinical development", "combat", "cross reactivity", "dosage", "emerging virus", "enzootic", "epidemic potential", "epizootic", "future epidemic", "human pathogen", "immunogenic", "immunogenicity", "in vivo", "innovation", "member", "mortality", "mouse model", "nanoparticle", "novel", "pathogen", "preclinical development", "preclinical evaluation", "prevent", "protective efficacy", "prototype", "response", "safety study", "transmission process", "vaccine candidate", "vaccine development", "vaccine efficacy", "vaccine platform", "vaccine trial", "vaccinology", "vector" ], "approved": true } }, { "type": "Grant", "id": "6826", "attributes": { "award_id": "5U19AI116497-07", "title": "Human Biomimetics for Mucosal Infections", "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": 6817, "first_name": "Rodolfo M.", "last_name": "Alarcon", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2015-03-15", "end_date": "2026-05-31", "award_amount": 1557840, "principal_investigator": { "id": 22650, "first_name": "Mary Kolb", "last_name": "Estes", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [ { "id": 566, "ror": "https://ror.org/02pttbw34", "name": "Baylor College of Medicine", "address": "", "city": "", "state": "TX", "zip": "", "country": "United States", "approved": true } ] }, "other_investigators": [ { "id": 22651, "first_name": "ANTHONY W", "last_name": "MARESSO", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, { "id": 22652, "first_name": "Pedro A", "last_name": "Piedra", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "awardee_organization": { "id": 566, "ror": "https://ror.org/02pttbw34", "name": "Baylor College of Medicine", "address": "", "city": "", "state": "TX", "zip": "", "country": "United States", "approved": true }, "abstract": "OVERALL PROJECT SUMMARY This application request is a renewal of a previous funded NAMSED Cooperative Research Center that encompassed a multidisciplinary team of basic scientists, physician scientists and engineers from institutions in the Texas Medical Center (Baylor College of Medicine, Rice University, and the MD Anderson Cancer Center). The objective of this new Biomimetic Cooperative Research Center (BCRC) is to build upon substantial progress that included 42 publications from the previous funding period to use human intestinal organoids (HIOs) and recent success in making nose and lung organoids (HNOs and HLOs) as biomimetics for the study of mucosal infectious diseases. Enteric and respiratory infections are a leading cause of worldwide morbidity and mortality; our understanding of the molecular and cellular drivers of infection of the key causal agents (studied in this proposal) is hampered due to the lack of sufficient cellular, animal, and human models and substantial host-dependent variation in infection susceptibility. The use of organoids will include next-generation engineering that augments cellular complexity to now include immune and neuronal cell and microbiome co-culture, integration of multiple organ or tissues systems, use of many donor lines to examine host-specific genetics and responses to infection, and higher-order 3D mechano-physiologic processes that may alter infection outcomes. This BCRC application integrates a team with multidisciplinary expertise in basic and translational research and innovation in virology, bacteriology, genomics, developmental biology and physiology, and biomedical engineering and biomaterial development to address important questions in the field. Project 1 will use HIOs to examine how human rotavirus and norovirus infection replication and immune responses are impacted by autologous immune and neuronal cell co-culture, co-infection with other pathogens, and commensal bacteria. Project 2 will examine the immunological response to respiratory syncytial virus and coronavirus infection in nasal and lung organoids and with autologous immune cells to establish preclinical HNO/HLO models that recapitulate human disease. HIOs will also be infected to evaluate mechanistically the lung-gut axis of respiratory virus disease. Project 3 will determine the molecular drivers of susceptibility to infection by enteroaggregative E. coli, including the effect of autologous immune co- culture, mechano-physiologic cues such as flow and stiffness, and a fully integrated intestinal system comprised of all four intestinal segments. All three projects, which have substantial synergy in theme and method, will be supported by three Cores: the Administrative Core (AC - to facilitate governing aspects of the team), Human Biomimetic Scientific Core (HBSC - to provide organoids and establish co-cultures), and the Engineering MicroEnvironment Scientific Core (EMEC - to provide platforms and bioengineering of mechano-physiologic cues into the organoid systems). At the completion of this funded period, our BCRC team will have advanced our understanding of the molecular, cellular and mechano-physiologic drivers of mucosal disease while generating new pre-clinical platforms to evaluate effective and safe therapeutics.", "keywords": [ "3-Dimensional", "Address", "Animal Model", "Apical", "Autologous", "Bacteria", "Bacterial Infections", "Bacteriology", "Bacteriophages", "Basic Science", "Biocompatible Materials", "Biological Models", "Biomechanics", "Biomedical Engineering", "Biomimetics", "Cancer Center", "Cell model", "Cells", "Cellular biology", "Clinical Microbiology", "Coculture Techniques", "Communicable Diseases", "Communities", "Complex", "Coronavirus Infections", "Cues", "Development", "Developmental Biology", "Disease", "Engineering", "Enteral", "Epithelial", "Foundations", "Functional disorder", "Funding", "Gastrointestinal tract structure", "Genetic", "Genomics", "Glycobiology", "Goals", "Human", "Human Biology", "Immune", "Immune response", "Immunology", "Infection", "Infectious Diseases Research", "Institution", "Intestinal Mucosa", "Intestines", "Investigational Drugs", "Knowledge", "Laboratory Study", "Lung", "Medical center", "Medicine", "Methods", "Microbe", "Modeling", "Molecular", "Morbidity - disease rate", "Mucous Membrane", "Neurons", "Norovirus", "Nose", "Organ", "Organoids", "Outcome", "Oxygen", "Pathogenesis", "Physicians", "Physiological", "Physiological Processes", "Physiology", "Polysaccharides", "Population Heterogeneity", "Pre-Clinical Model", "Predisposition", "Productivity", "Property", "Prophylactic treatment", "Proxy", "Publications", "Request for Applications", "Research", "Research Personnel", "Respiratory Syncytial Virus Infections", "Respiratory Tract Infections", "Respiratory syncytial virus", "Rice", "Role", "Rotavirus", "SARS-CoV-2 pathogenesis", "Scientist", "Site", "Surface", "System", "Technology", "Testing", "Texas", "Therapeutic", "Tissue Engineering", "Tissues", "Translating", "Translational Research", "Universities", "Variant", "Virus", "Virus Diseases", "Work", "biomaterial development", "body system", "co-infection", "college", "commensal bacteria", "enteric infection", "enteric virus infection", "enteroaggregative Escherichia coli", "expectation", "fluid flow", "gastrointestinal infection", "genetic manipulation", "gut-lung axis", "host-microbe interactions", "human coronavirus", "human disease", "human model", "innovation", "microbial", "microbiome", "microorganism", "mortality", "multidisciplinary", "next generation", "novel", "pathogen", "pathogenic microbe", "physiologic model", "pre-clinical", "preclinical study", "prevent", "respiratory", "respiratory infec" ], "approved": true } }, { "type": "Grant", "id": "6826", "attributes": { "award_id": "5U19AI116497-07", "title": "Human Biomimetics for Mucosal Infections", "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": 6817, "first_name": "Rodolfo M.", "last_name": "Alarcon", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2015-03-15", "end_date": "2026-05-31", "award_amount": 1557840, "principal_investigator": { "id": 22650, "first_name": "Mary Kolb", "last_name": "Estes", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [ { "id": 566, "ror": "https://ror.org/02pttbw34", "name": "Baylor College of Medicine", "address": "", "city": "", "state": "TX", "zip": "", "country": "United States", "approved": true } ] }, "other_investigators": [ { "id": 22651, "first_name": "ANTHONY W", "last_name": "MARESSO", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, { "id": 22652, "first_name": "Pedro A", "last_name": "Piedra", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "awardee_organization": { "id": 566, "ror": "https://ror.org/02pttbw34", "name": "Baylor College of Medicine", "address": "", "city": "", "state": "TX", "zip": "", "country": "United States", "approved": true }, "abstract": "OVERALL PROJECT SUMMARY This application request is a renewal of a previous funded NAMSED Cooperative Research Center that encompassed a multidisciplinary team of basic scientists, physician scientists and engineers from institutions in the Texas Medical Center (Baylor College of Medicine, Rice University, and the MD Anderson Cancer Center). The objective of this new Biomimetic Cooperative Research Center (BCRC) is to build upon substantial progress that included 42 publications from the previous funding period to use human intestinal organoids (HIOs) and recent success in making nose and lung organoids (HNOs and HLOs) as biomimetics for the study of mucosal infectious diseases. Enteric and respiratory infections are a leading cause of worldwide morbidity and mortality; our understanding of the molecular and cellular drivers of infection of the key causal agents (studied in this proposal) is hampered due to the lack of sufficient cellular, animal, and human models and substantial host-dependent variation in infection susceptibility. The use of organoids will include next-generation engineering that augments cellular complexity to now include immune and neuronal cell and microbiome co-culture, integration of multiple organ or tissues systems, use of many donor lines to examine host-specific genetics and responses to infection, and higher-order 3D mechano-physiologic processes that may alter infection outcomes. This BCRC application integrates a team with multidisciplinary expertise in basic and translational research and innovation in virology, bacteriology, genomics, developmental biology and physiology, and biomedical engineering and biomaterial development to address important questions in the field. Project 1 will use HIOs to examine how human rotavirus and norovirus infection replication and immune responses are impacted by autologous immune and neuronal cell co-culture, co-infection with other pathogens, and commensal bacteria. Project 2 will examine the immunological response to respiratory syncytial virus and coronavirus infection in nasal and lung organoids and with autologous immune cells to establish preclinical HNO/HLO models that recapitulate human disease. HIOs will also be infected to evaluate mechanistically the lung-gut axis of respiratory virus disease. Project 3 will determine the molecular drivers of susceptibility to infection by enteroaggregative E. coli, including the effect of autologous immune co- culture, mechano-physiologic cues such as flow and stiffness, and a fully integrated intestinal system comprised of all four intestinal segments. All three projects, which have substantial synergy in theme and method, will be supported by three Cores: the Administrative Core (AC - to facilitate governing aspects of the team), Human Biomimetic Scientific Core (HBSC - to provide organoids and establish co-cultures), and the Engineering MicroEnvironment Scientific Core (EMEC - to provide platforms and bioengineering of mechano-physiologic cues into the organoid systems). At the completion of this funded period, our BCRC team will have advanced our understanding of the molecular, cellular and mechano-physiologic drivers of mucosal disease while generating new pre-clinical platforms to evaluate effective and safe therapeutics.", "keywords": [ "3-Dimensional", "Address", "Animal Model", "Apical", "Autologous", "Bacteria", "Bacterial Infections", "Bacteriology", "Bacteriophages", "Basic Science", "Biocompatible Materials", "Biological Models", "Biomechanics", "Biomedical Engineering", "Biomimetics", "Cancer Center", "Cell model", "Cells", "Cellular biology", "Clinical Microbiology", "Coculture Techniques", "Communicable Diseases", "Communities", "Complex", "Coronavirus Infections", "Cues", "Development", "Developmental Biology", "Disease", "Engineering", "Enteral", "Epithelial", "Foundations", "Functional disorder", "Funding", "Gastrointestinal tract structure", "Genetic", "Genomics", "Glycobiology", "Goals", "Human", "Human Biology", "Immune", "Immune response", "Immunology", "Infection", "Infectious Diseases Research", "Institution", "Intestinal Mucosa", "Intestines", "Investigational Drugs", "Knowledge", "Laboratory Study", "Lung", "Medical center", "Medicine", "Methods", "Microbe", "Modeling", "Molecular", "Morbidity - disease rate", "Mucous Membrane", "Neurons", "Norovirus", "Nose", "Organ", "Organoids", "Outcome", "Oxygen", "Pathogenesis", "Physicians", "Physiological", "Physiological Processes", "Physiology", "Polysaccharides", "Population Heterogeneity", "Pre-Clinical Model", "Predisposition", "Productivity", "Property", "Prophylactic treatment", "Proxy", "Publications", "Request for Applications", "Research", "Research Personnel", "Respiratory Syncytial Virus Infections", "Respiratory Tract Infections", "Respiratory syncytial virus", "Rice", "Role", "Rotavirus", "SARS-CoV-2 pathogenesis", "Scientist", "Site", "Surface", "System", "Technology", "Testing", "Texas", "Therapeutic", "Tissue Engineering", "Tissues", "Translating", "Translational Research", "Universities", "Variant", "Virus", "Virus Diseases", "Work", "biomaterial development", "body system", "co-infection", "college", "commensal bacteria", "enteric infection", "enteric virus infection", "enteroaggregative Escherichia coli", "expectation", "fluid flow", "gastrointestinal infection", "genetic manipulation", "gut-lung axis", "host-microbe interactions", "human coronavirus", "human disease", "human model", "innovation", "microbial", "microbiome", "microorganism", "mortality", "multidisciplinary", "next generation", "novel", "pathogen", "pathogenic microbe", "physiologic model", "pre-clinical", "preclinical study", "prevent", "respiratory", "respiratory infec" ], "approved": true } }, { "type": "Grant", "id": "6831", "attributes": { "award_id": "5R01CA258297-02", "title": "Precision targeting of T cell cytotoxicity with PET", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Cancer Institute (NCI)" ], "program_reference_codes": [], "program_officials": [ { "id": 22660, "first_name": "LEELA RANI RANI", "last_name": "Avula", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2021-03-01", "end_date": "2026-02-28", "award_amount": 652933, "principal_investigator": { "id": 22661, "first_name": "Rahul", "last_name": "Aggarwal", "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": [ { "id": 22581, "first_name": "CHARLES Scott", "last_name": "CRAIK", "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 } ] }, { "id": 22662, "first_name": "Michael John", "last_name": "Evans", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, { "id": 22663, "first_name": "Lawrence", "last_name": "Fong", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "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": "The recent clinical success of inhibitors against immune checkpoint proteins (e.g. CTLA-4, PD-L1), which are thought to stimulate T cell responses against tumors, has revolutionized cancer therapy. Yet even among patients with high tumor mutational burden, only approximately 20-30% of patients achieve deep response, and discerning responders from non-responders is challenging with conventional imaging. On this basis, there is an urgent unmet need to develop biomarkers that distinguish responsive and treatment resistant patients, as well as identify patients at risk for undesired immune related adverse events. We hypothesized that an imaging biomarker capable of selectively measuring the biology that T cells use to impart cytotoxicity might address these unmet needs. Since antitumor T cell cytotoxicity is conferred primarily by the pro-apoptotic serine protease granzyme B, we have developed a peptide-based chemosensor we term “restricted interaction peptide” that enables spatiotemporal measurements of granzyme B proteolytic activity as the enzyme traverses the immunological synapse between T cell and target cell. Upon proteolytic cleavage of the full length, pro-form of the restricted interaction peptide (termed GB1) by granzyme B, a radiolabeled antimicrobial peptide is liberated and undergoes a spontaneous conformational shift that results in stable (and non-toxic) membrane association. We have shown that radiolabeled GB1 detects T cell activation in tumors and normal tissues elicited by systemic immune checkpoint inhibitors. Following on these encouraging preclinical data, we have now assembled a multidisciplinary team to conduct translational studies to evaluate the utility of granzyme B biochemistry as a biomarker. Over three specific aims, we will (1) perform IND enabling studies for 64Cu-GB1, (2) conduct a phase 0 first in human study to determine tracer safety, pharmacokinetics, and dosimetry, and (3) execute a phase I study to determine the accuracy for detection of urothelial and renal cancers undergoing a productive immune response due to treatment with standard of care immune checkpoint inhibitors. If successful, this project will establish a new paradigm for the measurement of T cell cytotoxicity in vivo that could have implications for the clinical management of other problematic human disorders like bacterial or viral (HIV, SARS-CoV) infections. Moreover, the imaging approach is entirely new, and favorable data emerging from this project could motivate further studies to develop restricted interaction peptides to measure the enzymology of other disease associated proteases in vivo with PET.", "keywords": [ "Address", "Adopted", "Apoptotic", "Aspartic Acid", "Bacterial Infections", "Biochemistry", "Biological Markers", "Biology", "Biopsy", "Blood", "CTLA4 gene", "Cancer Model", "Cancer Patient", "Cell membrane", "Cells", "Chemistry", "Clear cell renal cell carcinoma", "Clinic", "Clinical", "Clinical Management", "Data", "Detection", "Disease", "Drug Kinetics", "Enzymatic Biochemistry", "Enzymes", "Exposure to", "Family member", "Female", "Goals", "Granzyme", "HIV", "Hour", "Human", "Image", "Imaging technology", "Immune", "Immune checkpoint inhibitor", "Immune response", "Immune system", "Immunologic Markers", "Infection", "Injections", "Label", "Length", "Malignant neoplasm of urinary bladder", "Measurement", "Measures", "Mediating", "Membrane", "Modeling", "Molecular Conformation", "Mus", "Mutation", "Natural Killer Cell toxicity", "Neoplasm Metastasis", "Normal tissue morphology", "PET/CT scan", "Patients", "Peptide Hydrolases", "Peptides", "Phase", "Phase 0 Study", "Phospholipids", "Positron-Emission Tomography", "Proteins", "Radiolabeled", "Rattus", "Renal carcinoma", "Resistance", "Risk", "Rodent", "SARS coronavirus", "Safety", "Serine Protease", "Site", "Specificity", "Spleen", "T cell response", "T-Cell Activation", "T-Lymphocyte", "Technology", "Time", "Toxic effect", "Tracer", "Tumor Tissue", "Urothelial Cell", "Urothelium", "Viral", "Virus Diseases", "Work", "anti-CTLA-4 therapy", "anti-PD-1", "anti-PD-1/PD-L1", "antimicrobial peptide", "base", "cancer imaging", "cancer therapy", "checkpoint inhibition", "cohort", "combat", "cytotoxicity", "dosimetry", "enzyme activity", "experience", "extracellular", "first-in-human", "human imaging", "human study", "imaging approach", "imaging biomarker", "immune checkpoint", "immune-related adverse events", "immunological synapse", "immunomodulatory therapies", "in vivo", "inhibitor/antagonist", "innovation", "interest", "male", "multidisciplinary", "neoplastic cell", "novel", "phase 1 study", "pre-clinical", "programmed cell death ligand 1", "radiochemical", "radiotracer", "responders and non-responders", "response", "serial imaging", "spatiotemporal", "standard of care", "success", "translational study", "tumor", "uptake" ], "approved": true } } ], "meta": { "pagination": { "page": 1383, "pages": 1424, "count": 14236 } } }