Albert B. Sabin Vaccine Institute, Washington, DC, USA.
Expert Rev Vaccines. 2010 Oct;9(10):1219-30. doi: 10.1586/erv.10.107.
Over the next decade, a new generation of vaccines will target the neglected tropical diseases (NTDs). The goal of most NTD vaccines will be to reduce the morbidity and decrease the chronic debilitating nature of these often-forgotten infections – outcomes that are hard to measure in the traditional potency testing paradigm. The absence of measurable correlates of protection, a lack of permissive animal models for lethal infection, and a lack of clinical indications that do not include the induction of sterilizing immunity required us to reconsider the traditional bioassay methods for determining vaccine potency. Owing to these limitations, potency assay design for NTD vaccines will increasingly rely on a paradigm where potency testing is one among many tools to ensure that a manufacturing process yields a product of consistent quality. Herein, we discuss the evolution of our thinking regarding the design of a potency assay along these newly defined lines and its application to the release of the experimental Necator americanus-glutathione-S- transferase-1 (Na-GST-1) vaccine to prevent human hookworm infection. We discuss the necessary steps to accomplish the design and implementation of such a new potency assay as a resource for the burgeoning NTD vaccine community. Our experience is that much of the existing information is proprietary and needs to be pulled together in a single source to aid in our overall understanding of potency testing.
在未来十年，新一代疫苗将针对被忽视的热带病（NTDs）。大多数 NTD 疫苗的目标将是降低发病率，并降低这些经常被遗忘的感染的慢性致残性质——这些结果在传统的效力测试范式中很难衡量。缺乏可衡量的保护相关性、缺乏许可的致死性感染动物模型，以及缺乏不包括诱导绝育免疫的临床指征，这使得我们不得不重新考虑用于确定疫苗效力的传统生物测定方法。由于这些限制，NTD 疫苗的效力测定设计将越来越依赖于这样一种范式，即效力测试是确保制造过程产生一致质量产品的众多工具之一。在这里，我们讨论了我们关于沿着这些新定义的路线设计效力测定的思路的演变，以及将其应用于实验性美洲钩虫-谷胱甘肽-S-转移酶-1（Na-GST-1）疫苗的释放，以预防人类钩虫感染。我们讨论了完成这种新的效力测定设计和实施的必要步骤，作为新兴的 NTD 疫苗社区的资源。我们的经验是，大部分现有信息是专有的，需要整合到一个单一的来源中，以帮助我们全面了解效力测试。
