案例信息

标题：以RSV疫苗的研发为例分析疫苗药物的临床转化

【专业学位类别】公共卫生

【专业领域/方向】病毒-宿主相互作用 

【作者】郑子峥 

【单位】厦门大学公共卫生学院 

【关键词】疫苗、临床转化、呼吸道合胞病毒、安全性、有效性 

【适用课程】流行病学、转化医学、生物制品学 

【版权说明】真实性案例，仅用于教学目的 

【案例摘要】疫苗是保护人类健康的最重要武器之一，使得人类在面对传染病的威胁时首次化被动为主动，在降低死亡率和提高人均预期寿命方面发挥了不可替代的作用。尽管带来了显著的生命价值和经济价值，目前仍然有较多病原体尚未有安全有效的疫苗获批上市。一般来讲，疫苗从研发到获批临床使用需要10-20年的时间。RSV疫苗的研发从20世纪60年代至今历经了60年的时间，终于在2023年迎来曙光。尽管不同病原体具有不同的特征，但在研发过程中存在许多相同的问题。为了帮助理解限制或促进疫苗发展进程的因素，本案例以 RSV疫苗的发展历程为例，探讨疫苗在发展过程中可能面临的挑战以及机遇，使学生掌握疫苗临床转化的限制性因素和科学动力，了解疫苗临床转化经历的流程及评价指标，加强学生对药物临床转化的理解、提高学生开展疫苗学研究的能力。

Title: RSV vaccine: an example to analyze the clinical transformation of vaccine drugs 

Professional Degree Category: Master of Public Health 

Specialized fields: Virus-host interaction 

Authors: Zizheng Zheng 

Affiliation: School of Public Health, Xiamen University 

Key words: Vaccines, clinical transformation, respiratory syncytial virus, Safety, efficacy 

Abstract

Vaccines have been an invaluable asset in protecting human health, allowing us to take a proactive stance against the threat of infectious diseases and reducing mortality rates and improving life expectancy. Despite the immense life and economic value they bring, many pathogens still lack safe and effective vaccines that have been approved for use. Generally, the process of developing a vaccine and getting it approved for clinical use takes between 10-20 years. The research and development of the RSV vaccine, for example, has taken 60 years since the 1960s, with the dawn of its approval finally arriving in 2023. This case study aims to explore the challenges and opportunities that vaccines may face in the development process, in order to better understand the factors that limit or promote the development of vaccines. By examining the development process of the RSV vaccine, students can gain insight into the restrictive factors and scientific dynamics of vaccine clinical transformation, understand the process and evaluation indicators of vaccine clinical transformation experience, and strengthen their understanding of drug clinical transformation, ultimately improving their ability to carry out vaccine research.

【案例正文】

【案例说明书】