Task V10: Clinical Sample Evaluation for Anthrax Vaccines

任务 V10：炭疽疫苗的临床样品评估

• 批准号: 10392635
• 负责人: THOMAS RUDGE
• 金额: $ 33.88万
• 依托单位: BATTELLE CENTERS/PUB HLTH RES & EVALUATN
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-11-16 至 2022-11-15
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10392635
• 关键词: Anthrax Vaccines; Area; Biological; Bioterrorism; Clinical; Communicable Diseases; Contracts; Development; Educational workshop; Emerging Communicable Diseases; Evaluation; Feasibility Studies; Immunology procedure; Investigational New Drug Application; Licensing; Office of Administrative Management; Reporting; Safety; Sampling; Services; Site Visit; Testing; Toxicology; Training; Vaccines; Validation; efficacy testing; evaluation/testing; immunogenicity; novel vaccines; product development; testing services; vaccine candidate

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 activities required for the submission of Biologic License Application (BLA) and/or Investigational New Drug (IND) applications. Task areas include: 1) administrative management and technical support including training and workshops, and quality oversight and management (site visits, critical stage audits, and final study report audits), 2) development, qualification and validation of immune assays, 3) immunogenicity and efficacy testing, 4) non-clinical and clinical sample testing, and 5) safety/toxicology studies. These services will facilitate the development and introduction of new vaccine candidates and biologics (regulated by CBER) against potential agents of bioterrorism and emerging and re-emerging infectious diseases.

传染病疫苗和其他生物制品评估和测试服务(ETS)合同提供从早期可行性研究到提交生物许可证申请(BLA)和/或研究新药(IND)申请所需的各种产品开发服务。任务领域包括：1)行政管理和技术支持，包括培训和讲习班，以及质量监督和管理(现场访问、关键阶段审计和最终研究报告审计)，2)免疫分析的开发、鉴定和验证，3)免疫原性和有效性测试，4)非临床和临床样本测试，以及5)安全/毒理学研究。这些服务将促进开发和引入新的候选疫苗和生物制品(由CBER监管)，以对抗生物恐怖主义和新出现和重新出现的传染病的潜在病原体。