Department of Microbiology & Immunology, UNC-Chapel Hill School of Medicine, Chapel Hill, North Carolina, USA.
UNC HIV Cure Center, UNC-Chapel Hill School of Medicine, Chapel Hill, North Carolina, USA.
Clin Pharmacol Ther. 2021 Apr;109(4):987-999. doi: 10.1002/cpt.2207. Epub 2021 Mar 11.
In this paper, we review the key elements that should be considered to take a novel vaccine from the laboratory through to licensure in the modern era. This paper is divided into four sections. First, we discuss the host immune responses that we engage with vaccines. Second, we discuss how in vivo and in vitro studies can inform vaccine design. Third, we discuss different vaccine modalities that have been licensed or are in testing in humans. Last, we overview the basic principles of vaccine approvals. Throughout we provide real-world examples of vaccine development against infectious diseases, including coronavirus disease 2019 (COVID-19).
在本文中，我们回顾了从实验室到现代时代获得新型疫苗所应考虑的关键要素。本文分为四个部分。首先，我们讨论了我们所涉及的宿主免疫反应。其次，我们讨论了体内和体外研究如何为疫苗设计提供信息。第三，我们讨论了已经获得许可或正在人体测试的不同疫苗模式。最后，我们概述了疫苗批准的基本原则。在整个过程中，我们提供了针对传染病（包括 2019 年冠状病毒病（COVID-19））的疫苗开发的实际示例。
