Zuverink Madison, Barbieri Joseph T
Microbiology and Immunology, Medical College of Wisconsin, Milwaukee, Wisconsin, USA.
Microbiology and Immunology, Medical College of Wisconsin, Milwaukee, Wisconsin, USA
Clin Vaccine Immunol. 2017 Dec 5;24(12). doi: 10.1128/CVI.00275-17. Print 2017 Dec.
Select agents (SA) pose unique challenges for licensing vaccines and therapies. In the case of toxin-mediated diseases, HHS assigns guidelines for SA use, oversees vaccine and therapy development, and approves animal models and approaches to identify mechanisms for toxin neutralization. In this commentary, we discuss next-generation vaccines and therapies against ricin toxin and botulinum toxin, which are regulated SA toxins that utilize structure-based approaches for countermeasures to guide rapid response to future biothreats.
选择性生物制剂（SA）给疫苗和疗法的许可带来了独特的挑战。对于毒素介导的疾病，美国卫生与公众服务部（HHS）制定SA使用指南，监督疫苗和疗法的研发，并批准用于识别毒素中和机制的动物模型和方法。在本评论中，我们讨论针对蓖麻毒素和肉毒杆菌毒素的下一代疫苗和疗法，这两种毒素是受监管的SA毒素，利用基于结构的方法来制定应对措施，以指导对未来生物威胁的快速反应。
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