案例信息

标题：新冠疫苗诱导的细胞免疫应答评价

【专业学位类别】公共卫生

【专业领域/方向】临床药学

【作者】张天英

【单位】厦门大学公共卫生学院

【关键词】新冠疫苗、细胞免疫、疫苗评价

【适用课程】

【版权说明】真实性案例，仅用于教学目的

【案例摘要】疫苗诱导的免疫屏障是预防新冠病毒感染和控制重症及死亡最为经济有效的手段之一。系统科学的评估新冠疫苗免疫原性是疫苗迭代更新及评价受理签发程序的重要依据。由厦门大学、香港大学和万泰生物联合研制的鼻喷流感病毒载体新冠疫苗经过大规模III期临床试验证实了该疫苗针良好的安全性和广谱功效，并于2022年12月2日在中国获批紧急使用。本案例介绍我国首个鼻喷流感病毒载体新冠疫苗I/II期临床试验中，对疫苗细胞免疫评价的实验流程和评价体系。该研究主要使用酶联免疫斑点试验，对受试者外周血单个核细胞中疫苗特异性T细胞进行检测。结果显示，疫苗诱导了明显的细胞免疫应答且显著高于安慰剂组。通过解读该研究中细胞免疫检测这一环节，使学生了解细胞免疫检测基本原理，掌握这一评价体系的基本流程，培养学生开展临床试验免疫评价的能力。

Title: Evaluation of Cellular Immune Response Induced by COVID-19 Vaccine

Professional Degree Category: Master of Public Health

Specialized fields: 

Authors: Tianying Zhang

Affiliation: School of Public Health, Xiamen University

Key words:COVID-19 vaccine, cellular immunity, vaccine evaluation

Abstract

The immune barrier, induced by vaccines, serves as one of the most cost-effective strategies to prevent SARS-CoV-2 infection and manage severe illness and mortality. A comprehensive and scientific evaluation of the immunogenicity of COVID-19 vaccines forms a crucial foundation for the iterative refinement and assessment of vaccine licensing procedures. The nasal spray influenza virus vector COVID-19 vaccine, collaboratively developed by Xiamen University, the University of Hong Kong, and Wantai Bio, has demonstrated its safety and broad-spectrum efficacy through extensive Phase III clinical trials. Consequently, it received approval for emergency use in China on December 2, 2022.This case study introduces the experimental process and evaluation system used in the Phase I/II clinical trial of China’s inaugural nasal spray influenza virus vector COVID-19 vaccine, specifically focusing on the evaluation of vaccine-induced cellular immunity. The study primarily employs the enzyme-linked immunospot assay to detect vaccine-specific T cells in the peripheral blood mononuclear cells of the subjects. The results reveal that the vaccine triggers a significant cellular immune response, markedly higher than that in the placebo group.By interpreting the cellular immune detection component in this study, students can gain an understanding of the fundamental principles of cellular immune detection, master the basic workflow of this evaluation system, and develop their capabilities to conduct immune evaluations in clinical trials.

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【案例说明书】