Singh K, Mehta S
Malaria Vaccine Development Program (MVDP), International Centre for Genetic Engineering and Biotechnology (ICGEB) Campus, New Delhi, India.
J Postgrad Med. 2016 Jan-Mar;62(1):4-11. doi: 10.4103/0022-3859.173187.
Each novel vaccine candidate needs to be evaluated for safety, immunogenicity, and protective efficacy in humans before it is licensed for use. After initial safety evaluation in healthy adults, each vaccine candidate follows a unique development path. This article on clinical development gives an overview on the development path based on the expectations of various guidelines issued by the World Health Organization (WHO), the European Medicines Agency (EMA), and the United States Food and Drug Administration (USFDA). The manuscript describes the objectives, study populations, study designs, study site, and outcome(s) of each phase (Phase I-III) of a clinical trial. Examples from the clinical development of a malaria vaccine candidate, a rotavirus vaccine, and two vaccines approved for human papillomavirus (HPV) have also been discussed. The article also tabulates relevant guidelines, which can be referred to while drafting the development path of a novel vaccine candidate.
每种新型候选疫苗在获得使用许可之前，都需要在人体中进行安全性、免疫原性和保护效力评估。在对健康成年人进行初步安全性评估之后，每种候选疫苗都遵循独特的研发路径。本文关于临床研发的内容，基于世界卫生组织（WHO）、欧洲药品管理局（EMA）和美国食品药品监督管理局（USFDA）发布的各项指南的要求，对研发路径进行了概述。该文稿描述了临床试验各阶段（I-III期）的目标、研究人群、研究设计、研究地点以及结果。文中还讨论了一种疟疾候选疫苗、一种轮状病毒疫苗以及两种获批用于人乳头瘤病毒（HPV）的疫苗的临床研发实例。本文还将相关指南制成表格，在起草新型候选疫苗的研发路径时可供参考。
