Implementing Vaccine and Treatment Evaluation Unit (VTEU) Clinical Site

实施疫苗和治疗评估单位 (VTEU) 临床基地

• 批准号: 10493529
• 负责人: Karen L. Kotloff
• 金额: $ 209.86万
• 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: 2021-05-28 至 2024-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10493529
• 关键词: Academia; Address; Africa; Ambulatory Care Facilities; Area; Award; Biological Products; COVID-19; Clinic; Clinical; Clinical Protocols; Clinical Research; Clinical Trials; Collaborations; Communicable Diseases; Communities; Conduct Clinical Trials; Consultations; Contracts; Country; Devices; Diagnosis; Diagnostic; Diagnostic Equipment; 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; diagnostic tool; 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.

项目概要/摘要 马里兰大学医学院 (UMSOM) 疫苗开发和全球健康中心 (CVD) 自 1974 年起就已成为 VTEU 站点。VTEU 的目标是倡导创新概念 用于临床研究并实施评估疫苗、其他预防性生物制品的临床现场协议， 用于治疗和预防传染病和 CVD 的治疗、诊断和设备 为实现这一目标做好了独特的准备。 CVD 的专家和卓有成效的调查团队已 解决 NIAID 优先领域所需的所有领域的互补技能，并已建立 管理层计划有效地分配工作并同时进行多个项目。化学气相沉积是 我们因开展受控人体感染试验的能力而受到国际认可 疟疾、流感和肠道病原体，并在流行地区开展治疗和预防试验 疟疾和被忽视的热带病（NTD），这两者一直是许多人研究的重点 年。 CVD 可以接触到美国所有年龄段的健康受试者来进行这项研究和受试者 有特殊风险的患者，例如患有性传播感染 (STI) 的门诊患者以及 其他一般不需要住院的情况。国内现场的强大合作 临床试验经验丰富的CVD的VTEU在各年龄段的健康受试者中具有浪涌能力 以及美国孕妇等弱势群体，以应对突发公共卫生事件。 CVD的 国际合作者，包括非洲的两个长期永久实地基地，是非常宝贵的 为疟疾和被忽视的热带病流行的低资源国家的经过审查的国际试验地点提供资源 具有进行高质量 NIAID 和 VTEU 研究的经验。该提案描述了以下机制： 实施由领导小组 (LG) 和研究提出的概念产生的协议 社区，包括来自其他 VTEU、学术界、工业界、非政府组织的调查人员， 和DMID。这些概念将重点关注 NIAID 的优先领域，包括疟疾、被忽视的热带疾病、呼吸道感染、 特别是流感、肠道疾病、性传播感染以及新发传染病和其他传染病 考虑因素。根据我们即将完成的 VTEU 合同（2013-2023 年），CVD 获得了超过 23 个项目 任务订单，招募了超过 1,500 名参与者，并与国内外成功合作 网站。此续签申请旨在补充我们新授予的 VTEU 奖项 (1UM1AI148689) 2019 年 12 月收到，针对 AI18-046；因此，该奖项的资助期限仅限一年 我们的赞助计划管理部门遗漏了 7 年整年的资助请求。这 目前的提案旨在通过额外 6 年的资助来补充一年的资助。