Vaccine and Treatment Evaluation Unit at Saint Louis University

圣路易斯大学疫苗和治疗评估单位

• 批准号: 10267383
• 负责人: Daniel F. Hoft
• 金额: $ 50.22万
• 依托单位: SAINT LOUIS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-04-01 至 2021-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10267383
• 关键词: Adenovirus Vector; Adjuvant; Adult; Age; Anthrax disease; Arbovirus Infections; Area; Attenuated; BCG Vaccine; Beds; Biological Markers; Biological Response Modifier Therapy; Biology; Birds; Blood; Blood specimen; Childhood; Clinic; Clinical; Clinical Research; Clinical Trials Design; Collaborations; Communicable Diseases; Containment; Contracts; Dengue Fever; Devices; Diagnostic; Disease; Disease Outbreaks; Doctor of Philosophy; Elderly; Enrollment; Ensure; Enteral; Epidemiology; Evaluation; Evolution; Faculty; Flavivirus; Foundations; Future; Goals; HIV; HIV Vaccine Trials Network; Hepatitis; Hepatitis C virus; Human; Immunity; Immunology; Infection; Influenza; Influenza A Virus, H1N1 Subtype; Infrastructure; Inpatients; Institutional Review Boards; International; Knowledge; Laboratories; Leadership; Liver; Malaria; Microbiology; Modeling; Molecular; Molecular Biology; Molecular Immunology; Mucous Membrane; Mycobacterium bovis; National Institute of Allergy and Infectious Disease; Norovirus; Nurses; Parainfluenza; Parasitic Diseases; Patients; Pediatrics; Pharmacists; Phase; Phase II/III Trial; Plague; Prevention; Preventive; Procedures; Process; Protocols documentation; Quarantine; Readiness; Recombinants; Reporting; Research; Research Personnel; Resources; Safety; Saints; Salmonella; Sampling; Scientist; Services; Sexually Transmitted Diseases; Simplexvirus; Site; Smallpox; Special Population; Specialist; Standardization; Study models; Subunit Vaccines; Therapeutic Trials; Tissues; Translational Research; Tuberculosis; Tuberculosis Vaccines; Tularemia; United States National Institutes of Health; Universities; Utah; Vaccines; Vaccinia; Viral; Work; Yellow Fever; Yellow Fever Vaccine; ZIKA; base; biodefense; bioweapon; co-infection; design; disorder control; disorder prevention; efficacy trial; enteric pathogen; experience; first-in-human; flu; high risk; immunogenicity; immunosuppressed; implementation design; industry partner; influenza virus strain; influenza virus vaccine; investigator-initiated trial; medical schools; neglected tropical diseases; novel; novel marker; pandemic disease; pandemic influenza; pathogen; pathogenic bacteria; pathogenic virus; pharmacokinetics and pharmacodynamics; pregnant; prevent; priority pathogen; rBCG; research facility; response; seasonal influenza; skills; tool; trial design; tuberculosis immunity; vaccine development; vaccine efficacy; vaccine evaluation; vaccine trial; vaccinology; zika fever

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.

圣刘易斯大学（SLU）寻求扩大其服务的疫苗和治疗评价单位 （VTEU）网络，提供资源和专门知识，帮助网络实现其评估目标 疫苗、预防性生物制剂、传染病的治疗和诊断。丹尼尔·霍夫特博士，SLU VTEU PI，还担任VTEU领导小组（LG）应用程序的共同PI，由所有当前VTEU支持; 然而，无论谁领导LG，SLU将提供全力支持，以促进优秀的VTEU研究。 针对重点病原体的I-IV期疫苗和治疗试验的出色基础设施：SLU已服务于 作为一个VTEU 29年来，进行了数百个I-IV期试验，在健康和特殊人群的所有年龄， 并可提供独特的知识和广泛的基础设施，以支持VTEU网络目标。 试验设计优先领域的多样化知识和科学技能：SLU研究者包括疫苗学专家， 免疫学、季节性和大流行性流感、结核病、生物防御、紧急/紧急大流行性试验， 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）和突发疾病（2009年H1N1大流行性流感、H5和H7禽流感） 流感和寨卡/黄热病）。除了简化机构审查和合同外，SLU还可以做出贡献， 隔离设施，用于选择代理人工作和住院人员挑战。 受控人类感染模型：SLU开发了人类挑战模型的研究能力 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 用于野生型GMP流感病毒株挑战研究的密封设施，并已开发出一种活性 与SGS合作，使攻毒方案标准化，并获得流感攻毒株。 在首次人体、药物启动和药代动力学/药效学研究方面的专业知识：SLU具有 完成了数十项针对流感、结核病、 HCV、肠道病原体、潜在的生物武器和新出现的黄病毒。实验生物学研究 已经鉴定了使用人类血液、组织和粘膜样品的粘膜和全身免疫 生物标志物和目标的迭代流感和结核病疫苗的发展。 性传播感染（STI）专业知识：SLU在艾滋病毒疫苗试验网络中的10年为SLU提供了 在STI方面的专业知识。SLU还领导了一项44个地点的疱疹疫苗有效性试验（Herpevac）， 招募Herpevac研究中心已同意作为方案特定研究中心，以扩大我们的STI专业知识。SLU ID 跟踪了约450名HIV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，以满足未来新的ID挑战。