This research was supported by US National Institute on Aging grant AG032282, UK Medical Research Council grant MR/P005918/1, the Duke Center for Population Health and Aging P30 AG034424, and by the American Psychological Association and the Centers for Disease Control and Prevention (CDC Award # 6NU87PS004366-03-02). DCRI Early Phase Unit tests broad-spectrum influenza vaccine Tuesday, March 27, 2018 The Duke Early Phase Clinical Research (DEPRU) recently completed the first study cohort for a broad-spectrum investigational influenza vaccine that has the potential to be effective against multiple strains of the virus for five or more years at a time. A key goal of HIV-1 vaccine development is to induce long-lasting broadly neutralizing antibodies (bnAbs) that can inhibit HIV-1 infection. dr Emmanuel chip walter. Michael Anthony MoodyProfessor of Pediatrics. Walter is also the director of the Duke Vaccine and Trials Unit. Search. These VTEUs conduct clinical research to develop new vaccines and therapies for infectious diseases. As the Director of Program Administration, Chris oversees all Program Management activities for DHVI's Contracts Portfolio. Contact. The Duke Vaccine Trial Unit (DVTU) The Duke Vaccine Trial Unit (DVTU) is a consortium of investigators committed to conducting clinical investigations related to the control and prevention of infectious disease with an overarching goal of furthering our understanding of vaccine immune responses and correlates of protection from infection. For more information about the Neonatal Perinatal Research Unit or to learn more about our clinical trials, email us at npru@duke.edu, or call 919-681-4913. The Ophthalmology Clinical Research Unit (CRU) oversees clinical research activities in various subspecialties including cornea, glaucoma, oculoplastics, retina, pediatric ophthalmology, and neuro-ophthalmology. Immune profiling for vaccine trials. HIVRAD- Permar; Collaboration for AIDS Vaccine Discovery. Please note that this is a partial list of clinical trials available at Duke. A key feature of the VTEUs' success is their ability to enroll large numbers of volunteers into trials rapidly and vaccinate them in a safe, effective and quick manner. In addition to providing access to specialized instrumentation for Real-Time PCR, and Luminex-based multiplex assays, this unit assists investigators with design and implementation of molecular, protein, and cellular assays to quantify immune reconstitution or immune responses in . From a multimillion dollar grant from NIH, DIPC will assess the cellular immune responses of volunteers in a malaria vaccine trials through the Vaccine Trials Evaluation Unit (VTEU). New trials are added to the site regularly. Current Studies; Mother-Infant Health Programs The Duke Regional Biocontainment Laboratory (RBL) was built with funding from NIH to support basic research to develop drugs, diagnostics, and vaccines for emerging and reemerging infections and biodefense. For the first time since 2007, a new VTEU has been awarded to Duke. In addition, he provides oversight of regulatory compliance for DHVI clinical The study is a multicenter trial that will be conducted in up to approximately 100 sites globally. The Quality Assurance for Duke Vaccine Immunogenicity Programs (QADVIP) (Director: M. Sarzotti-Kelsoe) was originally created in 2002, under the name of Duke CFAR Central Quality Assurance Unit (CQAU), to implement a quality system for three HIV Vaccine Trials Network (HVTN) Endpoint Assay Laboratories. By presenting caregivers with a daunting task, giving researchers a pressing global problem to solve, and reshaping the landscape of working and learning, the COVID-19 pandemic could have derailed many of Duke's core missions. DHVI is pleased to announce the approval of a Phase 1 clinical trial of one of our most promising antibody treatments for COVID-19. Contact the Duke Recruitment Innovation Center at MyResearchPartners@duke.edu or 919-681-5698 . Doris Duke . Dr Smith recently joined Duke in 2017 from the University of Louisville and is a key member of the DVTU. The Unit maintains quality-controlled secure inventories of approved BSL2, BSL3, and Select Agent bacterial pathogens for RBL projects and collaborating investigators. Type of Research: There are more than two hundred clinical trials currently being conducted at the Duke Eye Center. When Thomas Denny, MSc, MPhil, professor of medicine and chief operating officer of the Duke Human Vaccine Institute, looks around the bright, bustling room, it's even better than he thought it would be. In these roles, Dr. Walter provides strategic and operational leadership for clinical research conducted at the Institute. Show Transcript. Advanced Search Bookmarks (0) My Accounts; Ask; Menu; Menu ☰ Menu. Led by Dr. Geeta Swamy, Senior Associate Dean for Regulatory Oversight & Research Initiatives in Clinical Research, the DVTU has conducted numerous studies in our maternal/fetal medicine department. Project 1: "Development of a maternal vaccine to passively-immunize infants against clade C HIV-1 infection". The Duke Human Vaccine Institute (DHVI) continues to lead with cutting edge vaccine research against infectious diseases that impact global health. Location. If you are interested in participating in a DVTU study, please contact us to receive notices about current and future research studies. These VTEUs conduct clinical research to develop new vaccines and therapies for infectious diseases. search for. Duke PIs: E. Walter, G. Swamy, K. Weinhold, G. Sempowski (HHSN2722013000171) The National Institute of Allergy and Infectious Disease Vaccine and Treatment Evaluation Units (NIAID VTEUs) play a key role in the development new and improved vaccines and therapies against infectious diseases. DVTU team: Lynn Harrington, Lori Henderson, Liz Schmidt, Stephanie Smith, Joyce Gandee, Luis Ballon, Kelly Year. In 2021, the Duke Department of Pediatrics was ranked #1 in NIH funding support for Pediatrics clinical departments throughout the country with $209,692,204 in research funding. Division faculty contribute to basic, translational, and clinical research that is leading to such innovations as: Better understanding of the mechanisms of . Additionally, we are developing a pan-coronavirus vaccine that will combat future iterations of COVID-19 & similar viruses, and also researching if saliva can be used as an accurate Please contact the Duke Early Phase Clinical Research Unit at 919-613-6244 or DEPRUvolunteer@duke.edu. The DVTU is also one of seven academic centers participating in the CDC's Clinical Immunization Safety Assessment (CISA) project. 19 , 20 BnAbs tend to develop by extensive somatic . View Website VTEUs have run hundreds of clinical trials, many of . Duke University, Box 90989 Durham, NC 27708-0989 Phone: 919-681-4993. contactdupri@duke.edu In these roles, Dr. Walter provides strategic and operational leadership for clinical research conducted at the Institute. The facility is equipped to produce and purify, at cost, HIV-1 Env proteins as standardized in vitro reagents that can be used in HIV vaccine research. Duke Vaccine and Trials Unit (DVTU) is one of nine Vaccine Treatment Evaluation Unit (VTEU) centers in the US studying new and improved vaccines and therapies against infectious diseases. A Duke expert who led the first trial of COVID vaccines in children under 12 will discuss the results and take questions in a briefing Oct. 27, 2021. Brain Injury Drug Study Needs Healthy Volunteers Men and women in good health are needed to participate in a research study to determine the safety, tolerability, and activity of an investigational drug that is being developed as a potential . Duke Human Vaccine Institute Overview The Duke Vaccine and Trials Unit's research activities have been funded by the National Institutes of Health, the Centers for Disease Control and Prevention (CDC), industry partners, and others. Dr. Emmanuel Walter, MD, MPH, Professor of Pediatrics, serves as the Duke Human Vaccine Institute (DHVI) Chief Medical Officer and directs the Duke Vaccine and Trials Unit. He serves as the Duke Human Vaccine Institute (DHVI) Chief Medical Officer and directs the Duke Vaccine and Trials Unit. Duke Vaccine and Trials Unit-RTP, Duke University PO Box 106008, Durham, NC 27710-6008. Dr. Swamy provides strategic vision and oversight of the regulatory components of the Duke Human Research Protection Program and assists with the development of broad-based She also oversees the Duke Office of Research Initiatives (DORI). DHVI has recently been awarded a grant to develop the next-generation of pan-coronavirus . In September 2013, the Duke Clinical Vaccine Unit was named a VTEU unit with Dr. Chip Walter and Dr. Geeta Swamy as the Co-principal Investigators. Research in the Moody lab is focused on understanding the B cell responses during infection, vaccination, and disease. Vaccines: The best protection for your kids. To learn more about the Duke Intensive Care Nursery, visit the Duke Division of Neonatology website. If an HIV-1-free generation is to be achieved, mother-to-child HIV-1 transmission (MTCT) of HIV-1 must be eradicated. Duke Vaccine and Trials Unit. Vaccines are one of the most critical public health investments and the Duke Human Vaccine Institute (DHVI) has been a global leader in vaccine research since the 1980s, addressing global health issues such as HIV/AIDS, tuberculosis, influenza and zika. In these roles, Dr. Walter provides strategic and operational leadership for clinical research conducted at the Institute. Join our mailing list for the latest news, updates and more. Although most of these SOPs were developed for AIDS clinical trials, many . . Protein Production Facility; MPER-Peptide Liposome Immunogen Testing; Duke Regional Biocontainment Laboratory. Dr. Walter is a pediatric infectious diseases specialist, pediatrician, primary care doctor and Professor of Pediatrics. The Clinical Trials Unit at Kilimanjaro Christian Medical Center has prepared numerous Standard Operating Procedures (SOPs) for clinical trials that meet NIH requirements. The Duke RBL supports sponsored research programs in the areas of: Vaccine / Therapeutic Development. Managed Care Operations Committee - Physicians19941997 . A licensed malaria vaccine remains elusive because so far no vaccine has induced a clinically beneficial immune response in recipients. Introduction to Flow Cytometry (Required Online Course) Take the quizzes at the end of each section. Type of Research: There are more than two hundred clinical trials currently being conducted at the Duke Eye Center. You may find additional clinical trials at Duke by searching clinicaltrials.gov. Duke Health's top priority is protecting the health and wellbeing of our patients, visitors, research participants, and team members. Additionally, he serves as the Overall Program Manager for the CIVICs Program which encompasses a Vaccine Center, Manufacturing and Toxicology Core, and Clinical Core. The RBL Immunology Unit is a service component of the Regional Biocontainment Laboratory at Duke (housed in GHRB). Morning sunlight beams through the floor-to-ceiling windows into the large open-air atrium that is the central point of Duke's new research campus, Duke Research and Discovery @RTP. She also oversees the Duke Office of Research Initiatives (DORI). The Duke Vaccine and Trials Unit is a consortium of investigators committed to conducting clinical investigations related to the control and prevention of infectious disease with an overarching goal of furthering our understanding of vaccine immune responses, correlates of protection from infection and enhancing vaccine safety. Dr. Emmanuel Walter, MD, MPH, Professor of Pediatrics, serves as the Duke Human Vaccine Institute (DHVI) Chief Medical Officer and directs the Duke Vaccine and Trials Unit. San Diego Dr. Denis Simon, ModeratorSenior Adviser to the President for China Affairs, Duke University CO-SPONSORS: The Center for Innovation . 2021-2022 China Innovation Series The Rise of the Techno-Security State under Xi Jinping Tuesday, January 25, 2022 SPEAKERS: Tai Ming CheungProfessor, School of Global Policy and Strategy, & Director, Institute on Global Conflict and Cooperation, U.C. Dr. Emmanuel Walter assumes directorship of Vaccine Unit. Record quiz results and bring to Classroom Session DiVa Training Manual Focus on: The BD FACSDiva Workspace, Cytometer Acquisition Controls, Tools for Data Analysis (Chapters2-4) Duke Vaccine & Trials Unit (DVTU) The Duke Vaccine Trial Unit (DVTU) mission is to conduct clinical investigations related to the control and prevention of infectious disease with overarching goals of furthering our understanding of vaccine immune responses and correlates of protection from infection and enhancing vaccine safety. Twin 9-year-old girls at Duke Health became the first in the United States to participate in Pfizer and BioNTech Phase 1 study to evaluate safety, tolerability and immunogenicity of the Pfizer-BioNTech COVID-19 vaccine in preventing COVID-19 among healthy children below the age of 12. Duke University Hospital has 957 inpatient beds and offers comprehensive diagnostic and therapeutic facilities, including a regional emergency/trauma center; a major surgery suite containing 51 operating rooms; an endo . Detailed Description: This study is an adaptive, randomized, double-blind, placebo-controlled trial to evaluate the safety and efficacy of novel therapeutic agents in hospitalized adults diagnosed with COVID-19. While antiretroviral prophylaxis strategies effectively prevent MTCT, they do not eliminate transmission . The Duke VTEU brings together a consortium of Duke investigators with extensive clinical and scientific vaccine expertise. DGHI is pleased to share these documents with others who are working in resource-limited locations. The Duke Vaccine and Trials Unit (DVTU), as part of the Human Vaccine Institute, is a consortium of investigators committed to conducting clinical investigations related to the control and prevention of infectious disease. Proficiency Testing / Quality Assurance. These reagents are intended to optimize clinical trial immune monitoring and facilitate Env immunogen discovery. "The immune response in children was as good as that seen for participants in the study, which tested the higher 30 ug dose in persons 16 to 25 years of age." If approved, the Pfizer and BioNTech vaccine would become the first in use for children in America under the age of 12. Led by Dr. Weinhold, Duke Surgery's Immune Profiling Core (DIPC) will assess the cellular immune responses of volunteers in an upcoming malaria vaccine trial through the VTEU. Most recently he has published primarily in the field of vaccines with a particular emphasis on early childhood influenza immunization. Proteins are not intended for use in humans or in clinical trials. Clements was in charge of the Duke Vaccine Unit from 1990-1996. g. rant support totaled approximately $1.75 million dollars. We have overarching goals of furthering our understanding of vaccine immune responses, correlates of protection from infection and enhancing vaccine safety. Duke University Hospital is consistently rated as one of the best in the United States and is known around the world for its outstanding care and groundbreaking research. He directs the Duke Vaccine and Trials Unit (DVTU), is a member of the Duke Human Vaccine Institute, and co-directs the Duke Primary Care Research Consortium at the Duke Clinical Research Institute. walte002@mc.duke.edu (919) 620-5346. External Grant Support. Tony Moody, MD is a Professor in the Department of Pediatrics, Division of Infectious Diseases and Professor in the Department of Immunology at Duke University Medical Center. Host Response / Immune Monitoring. DHVI has recently been awarded a grant to develop the next-generation of pan-coronavirus . Excess research support capacity in the RBL is also available to investigators as cost recovery through the three collaborative shared resource units. Immune profiling for cancer immunotherapy trials. Total funding could be up to $9 million over the course of the contract if all contract options are The coming COVID vaccine for children ages 5-11 is safe, effective and the best way for parents to protect their kids from the insidious disease, a Duke doctor who led a trial examining the vaccine's effectiveness said Wednesday. Dr. Smith is leading a study to assess the safety and immunogenicity of one or two doses of Sing2016 M2SR H3N2 influenza vaccine delivered intranasally in a healthy pediatric population 6 months through 17 years of age. Learn more. The Duke Vaccine and Trials Unit (DVTU) is a consortium of investigators committed to conducting clinical investigations related to the control and prevention of infectious disease. Vaccine Trials Unit Investigator Duke Translational Research Institute Durham, NC 2010 - 2018 Duke University Director Duke Perinatal Research Center . The VTEU designation builds on a model of successful vaccine research at Duke led by the DHVI, which was formed in 1990 to support vaccine research and development across many disciplines at Duke. Duke University Libraries. The Ophthalmology Clinical Research Unit (CRU) oversees clinical research activities in various subspecialties including cornea, glaucoma, oculoplastics, retina, pediatric ophthalmology, and neuro-ophthalmology. The participants -- Alejandra and Marisol Gerardo -- received their first vaccinations on Wednesday, March 24. Vaccine and Trials Unit; HIV Vaccine Research and Development. JR . But through the work of teams and individuals across Duke, it didn't. This 2021-22 group of Duke Presidential Award winners are prime examples of the dedication . The National Institute of Allergy and Infectious Diseases have recognized this importance by funding Vaccine and Treatment Evaluation Units (VTEUs) across the country for more than 50 years. Clinical Research Coordinator . The RBL Microbiology Unit is a collaborative research service component of the Regional Biocontainment Laboratory at Duke (housed in GHRB). Duke and PSOM: A similar approach was taken in a study involving mice that . Questions? The RBL Immunology Unit is a service component of the Regional Biocontainment Laboratory at Duke (housed in GHRB). The interdisciplinary series aims to enhance attendees' understanding of the climate crisis-including its social, political, and economic impacts . Emmanuel Benjamin Walter Jr.Professor of Pediatrics. Search. Advanced . Duke University Population Research Institute Contact. He serves as the Duke Human Vaccine Institute (DHVI) Chief Medical Officer and directs the Duke Vaccine and Trials Unit. Shared Resources; RBL Units; Duke Vaccine Trial Unit. If you are interested in participating in a DVTU study, please contact us to receive notices about current and future research studies. He is tasked with ensuring that all programmatic, contractual and financial This virtual event is part of the Gilman Climate Leaders Seminar Series (March 24 - May 12), designed by the Nicholas Institute for Environmental Policy Solutions and Duke University Energy Initiative and funded by the U.S. Department of State. Dr. The RBL has a comprehensive safety and operations program to provide state-of-the-art biocontainment facilities for BSL2 and BSL3 research. Our Duke Vaccine and Trials Unit Volunteer Registry is a way for people to let our team know that you are interested in learning more about any of our vaccine studies you may be interested in. "At DHVI, we're able to use in-house resources to rapidly go from bench to bedside," Sempowski says. The Duke Division of Medical Oncology applies our world-renowned research and treatment innovations to the delivery of leading-edge and compassionate care for individuals with cancer. 2608 Erwin Road, Suite 210. In 2019, Duke pediatric infectious diseases faculty led research programs funded by $34 million from 25 NIH awards (including twelve R01s, three P01s, one U01, and . Neoadjuvant ipilimumab therapy for non-small cell lung cancer (NSCLC . Since joining Duke, he has led protocol development on a study to assess the pharmacokinetics of plazomicin in children and has contributed heavily to a vaccine study assessing the safety and immunogenicity of an H7N9 influenza vaccine. Search & Find; Using the Library; Research Support; Course Support; Libraries; About; My Accounts Ask a Librarian Library Hours Search our . The mRNA-LNP vaccine platform has also been employed by our group to address difficult to make vaccines, such as a preventative HIV-1 vaccine candidate. The Duke University School of Medicine and DHVI also have robust clinical trials units, including the Duke Vaccine Trial Unit (DVTU), led by Emmanuel (Chip) Walter, MD. Emmanuel (Chip) Walter, M.D., MPH, professor of pediatrics, is the principal investigator of Duke's new VTEU. Dr. Smith is leading a study to assess the safety and immunogenicity of one or two doses of Sing2016 M2SR H3N2 influenza vaccine delivered intranasally in a healthy pediatric population 6 months through 17 years of age. Stay Up To Date. Dr. Emmanuel Walter Jr., a pediatrician and chief medical officer at . Congratulations to the members of the Duke Vaccine & Trials Unit (DVTU), led by Dr. Chip Walter, whose hard work over the past year has resulted in two articles published, on the same day, on COVID-19 prevention & treatment in the New England Journal of Medicine (NEJM). DURHAM, N.C. - The Duke Human Vaccine Institute's Vaccine and Treatment Evaluation Unit has received an initial award of approximately $5 million from the National Institute of Allergy and Infectious Diseases (NIAID) to support further research on Valley Fever Pneumonia. Vaccines are one of the most critical public health investments and the Duke Human Vaccine Institute (DHVI) has been a global leader in vaccine research since the 1980s, addressing global health issues such as HIV/AIDS, tuberculosis, influenza and zika. Archives & Manuscripts Collection Guides Search within search for. We have instituted safety measures throughout Duke Health hospitals and clinics to keep everyone safe and protected from possible exposure to COVID-19. Durham, NC 27705 This will be a temporary treatment until a vaccine is developed. Dr. Walter is a pediatric infectious diseases specialist, pediatrician, primary care doctor and Professor of Pediatrics. 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