TASK X22: Non-GLP Safety Study of multivalent toxoid S. aureus Vaccine (IBT-V02) in nonhuman primates for Integrated Biotherapeutics

任务 X22：用于综合生物治疗的多价类毒素金黄色葡萄球菌疫苗 (IBT-V02) 在非人灵长类动物中的非 GLP 安全性研究

• 批准号: 9537826
• 负责人: RANDI HORNBACK
• 金额: $ 36.38万
• 依托单位: BATTELLE CENTERS/PUB HLTH RES & EVALUATN
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-07-28 至 2018-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9537826
• 关键词: Antimicrobial Resistance; Biological Response Modifier Therapy; Bioterrorism; Clinical; Communicable Diseases; Contracts; Development; Drug resistance; Emerging Communicable Diseases; Feasibility Studies; Phase; Sampling; Services; Staphylococcus aureus; Testing; Toxicity Tests; Toxoids; Vaccines; assay development; efficacy testing; evaluation/testing; immunogenicity; nonhuman primate; novel vaccines; pathogen; product development; safety study; safety testing; vaccine development

The Evaluation and Testing Services (ETS) for Vaccines and Other Biologics for Infectious Diseases contract provides a variety of product development services from early feasibility studies through manufacture of Phase I/II material, including assay development; immunogenicity and efficacy testing; clinical and nonclinical sample testing; and safety and toxicity testing. These services will facilitate the development and introduction of new vaccines and biologics against potential agents of bioterrorism, drug-resistant pathogens, and emerging and re-emerging infectious diseases.

传染病合同的疫苗和其他生物制剂的评估和测试服务（ETS）提供了各种产品开发服务，从早期可行性研究到制造I/II期材料，包括分析开发；免疫原性和功效测试；临床和非临床样品测试；以及安全性和毒性测试。 这些服务将促进对生物恐怖，耐药病原体以及新兴和重新出现感染性疾病的潜在药物的新疫苗和生物制剂的开发和引入。