VTEU Supplement

VTEU 补充

• 批准号: 10303002
• 负责人: Karen L. Kotloff
• 金额: $ 518万
• 依托单位: UNIVERSITY OF MARYLAND BALTIMORE
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-02-08 至 2021-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10303002
• 关键词: Academia; Address; Africa; Ambulatory Care Facilities; Area; Award; Biological Response Modifier Therapy; COVID-19; Clinic; Clinical; Clinical Protocols; Clinical Research; Clinical Trials; Collaborations; Communicable Diseases; Communities; Conduct Clinical Trials; Consultations; Contracts; Country; Devices; Diagnosis; Diagnostic; Disease; Disease Outbreaks; Ebola; Emerging Communicable Diseases; Enrollment; Enteral; Epidemic; Equipment; Evaluation; Formulation; Funding; Goals; Government; Guidelines; Health; Hospitalization; Human; Human Resources; Immune response; Industry; Infection; Influenza; International; Intervention; Investigation; Laboratories; Laws; Leadership; Malaria; Maryland; Medical Device; Mentors; Methods; Modeling; National Institute of Allergy and Infectious Disease; Nongovernmental Organizations; Outpatients; Participant; Patients; Personal Satisfaction; Phase; Policies; Population; Pregnant Women; Prevention; Prevention trial; Preventive; Prognostic Marker; Program Development; Protocols documentation; Public Health; Publishing; Reagent; Regulation; Reporting; Research; Research Personnel; Research Subjects; Resources; Respiratory Tract Infections; Risk; Sampling; Schedule; Scientist; Services; Sexually Transmitted Diseases; Site; Source; System; Systems Biology; Therapeutic; United States National Institutes of Health; Universities; Vaccines; Vulnerable Populations; Work; age group; aging population; base; clinical research site; design; dosage; enteric pathogen; epidemiology study; experience; global health; healthy volunteer; human subject; improved; innovation; medical schools; microbiota; neglected tropical diseases; next generation; novel; novel diagnostics; novel vaccines; organizational structure; pathogen; patient population; population based; pre-clinical; predictive marker; prevent; product development; programs; public health emergency; research study; response; sample collection; serosurvey; skills; targeted delivery; therapeutic vaccine; tool; treatment trial; vaccine access; vaccine candidate; vaccine development; vaccine evaluation

Project Summary/Abstract The University of Maryland School of Medicine (UMSOM) Center for Vaccine Development and Global Health (CVD) has been an established VTEU site since 1974. The goal of the VTEUs is to initiate innovative concepts for clinical research and implement clinical site protocols for evaluating vaccines, other preventive biologics, therapeutics, diagnostics, and devices for the treatment and prevention of infectious diseases, and CVD is uniquely poised to accomplish this goal. CVD's expert and accomplished investigative team has complementary skill sets in all areas necessary to address the NIAID priority areas, with established management plans to effectively allocate work and conduct multiple projects simultaneously. CVD is internationally recognized for our capacity and capability to conduct controlled human infection trials for malaria, influenza, and enteric pathogens and to implement treatment and prevention trials in endemic areas for malaria and neglected tropical diseases (NTD), both of which have been a focus of its research for many years. CVD has access to U.S. populations of healthy subjects in all age groups for this research and subjects with special risks, such as patients attending outpatient clinics with sexually transmitted infection (STI) and other conditions that generally do not requiring hospitalization. Strong domestic collaborations at sites experienced in clinical trials provide the CVD's VTEU with surge capacity among healthy subjects of all ages and vulnerable populations such as pregnant women in the U.S. to address public health emergencies. CVD's international collaborators, including two long-standing permanent field sites in Africa, are an invaluable resource for vetted international trial sites in low resource countries endemic for malaria and NTD with experience in conducting high quality NIAID and VTEU studies. This proposal describes mechanisms to implement protocols that arise from concepts proposed by the Leadership Group (LG) and the research community including investigators from other VTEUs, academia, industry, non-governmental organizations, and DMID. These concepts will focus on NIAID priority areas, including malaria, NTD, respiratory infections, particularly influenza, enteric diseases, STI, and emerging infectious diseases and other infectious disease considerations. Under our VTEU contract that is nearing completion (2013-2023), CVD was awarded over 23 Task Orders, enrolled over 1,500 participants, and successfully collaborated with national and international sites. This renewal application is intended to supplement the new VTEU award (1UM1AI148689) that we received in December, 2019 in response to AI18-046; funding for this award was limited to one year as a result of an omission by our Sponsored Programs Administration to include a request for 7 full years of funding. The current proposal seeks to supplement that one year award with an additional 6 years of funding.

项目总结/摘要 马里兰州大学医学院（UMSOM）疫苗开发和全球健康中心 (CVD)自1974年以来一直是VTEU网站。VTEU的目标是提出创新概念 进行临床研究，并实施临床研究中心方案，以评估疫苗、其他预防性生物制剂， 用于治疗和预防传染病的治疗剂、诊断剂和装置，并且CVD是 为实现这一目标做好了独特的准备。CVD的专家和有成就的调查团队已经 在解决NIAID优先领域所需的所有领域的互补技能组合， 管理层计划有效分配工作，同时开展多个项目。CVD是 国际公认的能力和能力进行控制的人类感染试验， 疟疾、流感和肠道病原体，并在流行地区进行治疗和预防试验 疟疾和被忽视的热带病（NTD），这两种疾病一直是其研究的重点， 年CVD可以访问美国所有年龄组的健康受试者人群进行本研究， 有特殊风险的患者，如患有性传播感染（STI）的门诊患者， 其他一般不需要住院治疗的情况。在研究中心开展强大的国内合作 临床试验中的经验为CVD的VTEU在所有年龄的健康受试者中提供了浪涌能力 以及美国孕妇等弱势群体，以应对突发公共卫生事件。CVD 国际合作者，包括两个长期在非洲的永久现场，是一个宝贵的 在疟疾和NTD流行的低资源国家的经审查的国际试验中心的资源， 在进行高质量的NIAID和VTEU研究的经验。该提案描述了各种机制， 实施由领导小组（LG）和研究提出的概念所产生的协议 包括来自其他VTEU、学术界、工业界、非政府组织的调查人员， 的DMID。这些概念将侧重于NIAID的优先领域，包括疟疾、NTD、呼吸道感染， 特别是流感、肠道疾病、性传播感染和新发传染病及其他传染病 注意事项。根据我们即将完成的VTEU合同（2013-2023年），CVD获得了超过23 任务订单，招收了1，500多名参与者，并成功地与国家和国际 网站.此更新申请旨在补充新的VTEU奖（1UM 1AI 148689），我们 2019年12月收到，以响应AI 18 -046;因此，该奖项的资助仅限于一年 我们的赞助项目管理局遗漏了一个7年的资金申请。的 目前的建议是，在这一年的奖励之外，再提供6年的资金。