Vaccine and Treatment Evaluation Unit at Saint Louis University

圣路易斯大学疫苗和治疗评估单位

基本信息

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
项目类别：
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

项目摘要

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) 寻求将其服务扩展到疫苗和治疗评估部门 (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、预防性生物制剂、治疗和诊断。 Daniel Hoft 博士，SLU VTEU PI，还担任由所有当前 VTEU 支持的 VTEU 领导小组 (LG) 申请的联合 PI；然而，无论谁领导LG，SLU都将全力支持推动优秀的VTEU研究。针对优先病原体的 I-IV 期疫苗和治疗试验拥有出色的基础设施：SLU 已提供服务作为 VTEU 29 年，在各个年龄段的健康和特殊人群中进行了数百项 I-IV 期试验，并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多样化知识和科学技能：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、生物防御、紧急/紧急大流行病试验、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）和突发疾病（2009 年 H1N1 流感、禽 H5 和 H7）流感和寨卡/黄热病）。除了简化机构审查和签约之外，SLU 还可以做出贡献用于特定特工工作和住院人类挑战的收容设施。受控人类感染模型：SLU 已开发出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力。我们提供23个床位的空运用于野生型 GMP 流感毒株挑战研究的遏制设施，并开发了一种活性与 SGS 合作标准化挑战方案并获取流感挑战毒株。首次人体研究、研究者发起的以及药代动力学/药效学研究方面的专业知识：SLU 拥有完成了数十项首次人体试验和研究者发起的针对流感、结核病、 HCV、肠道病原体、潜在生物武器和新出现的黄病毒。实验生物学研究粘膜和全身免疫与人类血液样本、组织和粘膜样本已鉴定流感和结核疫苗迭代开发的生物标志物和目标。性传播感染 (STI) 专业知识：SLU 在 HIV 疫苗试验网络中的 10 年经验为 SLU 提供了帮助具有性传播感染方面的专业知识。 SLU 还领导了一项 44 点疱疹疫苗功效试验 (Herpevac)，其中两项最高注册 Herpevac 站点已同意作为协议特定站点，以扩展我们的 STI 专业知识。 SLU ID 跟踪约 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来应对未来新的 ID 挑战。