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: 10447274
• 负责人: Daniel F. Hoft
• 金额: $ 30.55万
• 依托单位: SAINT LOUIS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-08-12 至 2023-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10447274
• 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.

圣路易斯大学（SLU）试图将其服务扩展到疫苗和治疗评估单位 （VTEU）网络提供资源和专业知识，以帮助网络实现其评估目标 传染病的疫苗，预防性生物制剂，治疗剂和诊断。 Daniel Hoft博士，Slu Vteu PI也是所有当前VTEUS支持的VTEU领导小组（LG）申请的Co-Pi； 但是，无论谁领导LG，SLU都将提供全力支持以促进出色的VTEU研究。 I-IV期疫苗和针对优先病原体的治疗试验的出色基础设施：SLU已服务 作为VTEU 29年，在所有年龄段的健康和特殊人群中进行了数百阶段IV试验， 并可以提供独特的知识和广泛的基础架构来支持VTEU网络目标。 试验设计优先领域的多样化知识科学技能：SLU研究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，生物陷入困境，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 arboviral疾病。我们还提供最先进的多平台OMICS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的紧急试验 （天花，炭疽，瘟疫和tularemia）和新兴疾病（2009 H1N1大流行流感，禽类H5和H7 流感和寨卡/黄热病）。除了简化的机构审查和合同外，SLU还可以贡献 精选代理工作和住院的人类挑战的遏制设施。 受控的人类感染模型：SLU已经发展了人类挑战模型研究的能力 流感，副氟氟扎，牛ac，沙门氏菌和结核病免疫。我们提供23张床的空降 使用野生GMP流感菌株进行挑战研究的遏制设施，并开发了一种活跃的 与SGS合作以标准化挑战协议并获得流感挑战率。 人类，研究人员发射和药代动力学/药效学研究的专业知识：SLU具有 完成了数十个人类和研究者引发的疫苗试验，针对流感，结核病， HCV，肠道病原体，潜在的生物武器和新兴的黄病毒。实验生物学研究 人类血液，组织和粘膜样品样本的粘膜和全身免疫已鉴定 迭代流感和结核病疫苗发育的生物标志物和靶标。 性传播感染（STI）专业知识：SLU在HIV疫苗试验中的10年提供了SLU 具有STI的专业知识。 SLU还领导了44位疱疹疫苗功效试验（HERPEVAC），其中两个最高 注册Herpevac网站已同意作为特定于协议的网站，以扩大我们的STI专业知识。 slu ID 遵循约450名HIV患者，并与几位分子病毒学家密切合作。 SLU期待提供其专业知识和能力，以应对未来的新ID挑战。