Animal Medicine COVID Support

动物医学新冠肺炎支持

基本信息

批准号：
10930606
负责人：
Mario Roederer
金额：
$ 345.35万
依托单位：
NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES
依托单位国家：
美国
项目类别：
财政年份：
资助国家：
美国
起止时间：
至
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10930606
关键词：
Accreditation Agreement Alphavirus Analgesics Anesthesia procedures Animal Care and Use Committees Animal Husbandry Animal Model Animals Blood Breeding Caring Clinical Trials Collaborations Collection Consultations Contracts Development Disease Educational process of instructing Electroporation Emerging Communicable Diseases Ensure Guidelines Human Influenza Injections Institution Laboratory Animals Medicine Methods Modeling Monitor Mus Operative Surgical Procedures Oral Administration Policies Preparation Preventive medical care Principal Investigator Procedures Regulation Research Research Personnel Research Project Grants Research Support Resources Rodent Safety Serum Services Tissues Toxicology Training Translational Research Vaccine Research Vaccines Vendor animal care animal facility animal model development biodefense coronavirus disease good laboratory practice in vivo model development novel novel vaccines operation pre-clinical preclinical safety product development programs quality assurance translational research program vaccine delivery vaccine efficacy

项目摘要

The Translational Research Program (TRP) serves three major functions at the VRC: 1) provides centralized support and service for all in vivo research conducted at the VRC, 2) conducts collaborative research and animal model development, and 3) operates a fully accredited lab animal facility. TRP provides all aspects of oversight and programmatic assistance to support teaching, training, and in vivo research by managing all preclinical safety and regulatory issues, ensuring judicious and humane use of animals in compliance with all institutional, local, state, and federal guidelines. It is the VRC primary resource for consultation, collaboration, and professional assistance in selecting appropriate animal models or establishing novel models to study disease and vaccine effects. TRP pursues independent and collaborative research projects related to animal model and preclinical product development for influenza, emerging infectious diseases such as alphaviruses, and other biodefense-focused diseases. Translational research is conducted to advance vaccine products from preclinical stages toward human clinical trials by actively monitoring and overseeing efficacy, safety, and toxicology studies in preparation for regulatory oversight of product development. TRP also investigates novel vaccine delivery methods to enhance efficiency, vaccine efficacy, and safety. TRP serves as a fully accredited AAALAC in-house animal facility, adhering to all federal regulations. The facility provides quality animal husbandry services, veterinary care, and facility management support for rodents. The facility offers preventive medical care, routine surveillance, and quality assurance for vendor- and colony-produced animals and may also establish and maintain its own mouse breeding colonies if necessary. A variety of technical services are performed by facility staff, including parenteral injections or oral administration of Animal Care and Use Committee (ACUC)-approved experimental materials; blood, tissue, and serum collection; surgical manipulations; animal identification procedures; electroporation procedures; anesthesia/analgesic administration; and other procedures as needed. The veterinary care unit also offers training for those who wish to perform these procedures themselves. For VRC studies conducted at other facilities, TRP establishes contractual agreements and coordination between investigators and these facilities. Within the in-house facility and contracted facilities, TRP ensures high-quality research in accordance with regulatory guidelines and compliance with good laboratory practices (GLP) and biosafety level requirements as essential.

转化研究计划（TRP）在VRC上发挥了三个主要功能：1）为在VRC上进行的所有体内研究提供了集中的支持和服务，2）进行了协作研究和动物模型开发，3）经营完全认可的实验室动物设施。 TRP通过管理所有临床前的安全和监管问题，提供监督和程序援助的各个方面，以支持教学，培训和体内研究，从而确保对动物的明智和人道使用，符合所有机构，地方，州和联邦指南。它是VRC的主要资源，用于选择适当的动物模型或建立新型模型以研究疾病和疫苗作用的新型资源。 TRP追求与动物模型和临床前产品开发相关的独立和协作研究项目，用于流感，新兴的传染病，例如α病毒和其他以生物形式为中心的疾病。进行转化研究是为了通过积极监测和监督疗效，安全性和毒理学研究来准备疫苗产品从临床前阶段推进人类临床试验，以准备监管产品开发的监管。 TRP还研究了新型的疫苗输送方法，以提高效率，疫苗功效和安全性。 TRP是遵守所有联邦法规的完全认可的AAAALAC内部动物设施。该设施为啮齿动物提供优质的畜牧业服务，兽医护理和设施管理支持。该设施为供应商和殖民地生产的动物提供了预防性医疗保健，常规监视以及质量保证，并且在必要时也可以建立和维护自己的小鼠育种菌落。设施人员进行了各种技术服务，包括肠胃外注射或口服动物护理委员会（ACUC）批准的实验材料；血液，组织和血清收集；手术操纵；动物识别程序；电穿孔程序；麻醉/止痛药；以及其他必要的程序。兽医护理部门还为那些希望自己执行这些程序的人提供培训。对于在其他设施进行的VRC研究，TRP建立了调查人员与这些设施之间的合同协议和协调。在内部设施和签约设施中，TRP确保按照监管指南和遵守良好的实验室实践（GLP）（GLP）和生物安全水平的要求确保高质量的研究。