Vaccine and Treatment Evaluation Unit at Saint Louis University

圣路易斯大学(SLU)寻求将其服务扩大到疫苗和治疗评价股 (VTEU)网络提供资源和专业知识，帮助网络实现其评估目标 传染病的疫苗、预防性生物制品、治疗和诊断。丹尼尔·霍夫特博士，SLU VTEU PI，还充当由所有当前VTEU支持的VTEU领导小组(LG)应用的联合PI； 然而，无论谁领导LG，SLU都将全力支持推动杰出的VTEU研究。 针对优先病原体的I-IV阶段疫苗和治疗试验的出色基础设施：SLU发挥了作用 作为VTEU工作了29年，在所有年龄段的健康和特殊人群中进行了数百次I-IV期试验， 并且可以提供独特的知识和广泛的基础设施来支持VTEU网络目标。 试验设计优先领域的不同知识和科学技能：SLU调查人员包括疫苗学专家， 免疫学、季节性和大流行性流感、结核病、生物防御、紧急/紧急大流行试验、 肝脏/肠道疾病、性传播感染、疟疾/被忽视的热带疾病、流行病学和 虫媒病毒疾病。我们还提供最先进的多平台组学核心专业知识。 紧急国家准备试验：SLU领导了针对潜在生物武器的疫苗紧急试验 (天花、炭疽、鼠疫和兔热病)和紧急疾病(2009年H1N1大流行流感、H5和H7禽流感) 流感和寨卡病毒/黄热病)。除了简化机构审查和合同外，SLU还可以作出贡献 用于选择代理工作和住院人工挑战的遏制设施。 受控人类感染模型：SLU开发了人类挑战模型研究的能力 流感、副流感、牛痘、沙门氏菌和结核病免疫。我们提供23个床位的空降 针对野生型GMP流感毒株的挑战研究的遏制设施，并已开发出一种活性 与SGS合作标准化挑战方案并获得流感挑战毒株。 在首例人类、研究人员发起和药代/药效学研究方面的专业知识：SLU拥有 完成了数十项人类首例和研究人员发起的流感、结核病疫苗试验， 丙型肝炎病毒、肠道病原体、潜在的生物武器和新出现的黄病毒。的实验生物学研究 人体血液、组织和粘膜样本的粘膜免疫和系统免疫已确认 反复开发流感和结核病疫苗的生物标记物和靶标。 性传播感染(STI)的专业知识：SLU在HIV疫苗试验网络的10年工作提供了SLU 拥有STI方面的专业知识。SLU还领导了一项44个地点的疱疹疫苗疗效试验(Herpevac)，以及两个最高的 加入Herpevac的网站已同意作为议定书特定网站，以扩大我们的STI专业知识。SLU ID 跟踪约450名艾滋病毒患者，并与几位分子病毒学家密切合作。 SLU期待着提供其专业知识和能力，以应对未来新的身份识别挑战。

Saint Louis University (SLU) seeks to expand its service to the Vaccine and Treatment Evaluation Unit (VTEU) network providing resources and expertise to help the network achieve its objectives of evaluating vaccines, preventive biologics, therapeutics and diagnostics for infectious diseases. Dr. Daniel Hoft, SLU VTEU PI, also serves as Co-PI for a VTEU Leadership Group (LG) application supported by all current VTEUs; however, regardless of who leads the LG, SLU will provide full support to promote outstanding VTEU research. Outstanding infrastructure for phase I-IV vaccine & therapeutic trials against priority pathogens: SLU has served as a VTEU for 29 years, conducted hundreds of phase I-IV trials in healthy and special populations of all ages, and can provide unique knowledge and extensive infrastructure to support VTEU network goals. Diverse knowledge scientific skills for trial design priority areas: SLU investigators include experts in vaccinology, immunology, seasonal and pandemic influenza, tuberculosis, biodefense, urgent/emergent pandemic trials, liver/enteric diseases, sexually transmitted infections, malaria/neglected tropical diseases, epidemiology and arboviral diseases. We also provide state-of-the art multi-platform omics core expertise. Urgent national preparedness trials: SLU has led urgent trials of vaccines against potential bioweapons (smallpox, anthrax, plague and tularemia), and emergent diseases (2009 H1N1 pandemic flu, avian H5 and H7 flu and Zika/Yellow Fever). In addition to streamlined institutional review and contracting, SLU can contribute containment facilities for select agent work and inpatient human challenge. Controlled Human Infection Models: SLU has developed the capacity for human challenge models to study influenza, parainfluenza, vaccinia, salmonella and tuberculosis immunity. We provide a 23-bed airborne containment facility for challenge studies with wild type GMP influenza strains, and have developed an active collaboration with SGS to standardize challenge protocols and obtain influenza challenge strains. Expertise in First-in-Human, investigator-initiated and pharmacokinetic/pharmacodynamic studies: SLU has completed dozens of first-in-human and investigator-initiated trials of vaccines against influenza, tuberculosis, HCV, enteric pathogens, potential bioweapons and emerging flaviviruses. Experimental biology studies of mucosal and systemic immunity with human samples of blood, tissue and mucosal samples have identified biomarkers and targets for iterative influenza and tuberculosis vaccine development. Sexually transmitted infection (STI) expertise: SLU's 10 years in the HIV Vaccine Trials Network provided SLU with expertise in STI. SLU also led a 44-site herpes vaccine efficacy trial (Herpevac), and two of the highest enrolling Herpevac sites have agreed to serve as Protocol-Specific Sites to expand our STI expertise. SLU ID follows ~450 HIV patients and closely collaborates with several molecular virologists. SLU looks forward to providing its expertise and capacities to meet the new ID challenges of the future.