摘要
结核病(tuberculosis,TB)是由结核分枝杆菌引起的一种免疫相关疾病。卡介苗(BCG)是目前唯一可用的抗结核疫苗,但其对全人群的保护效果备受争议,新型结核病疫苗研究是抗结核行动的关键。疫苗诱导机体产生的免疫应答水平对预测和评估结核病疫苗的作用效果具有重要意义,因此在新型结核病疫苗临床评价过程中,其免疫原性评价至关重要。本文就近年来临床期在研结核病新疫苗主要的免疫学评价方法及其免疫学特性进行综述,为结核病疫苗研究者提供参考。
Tuberculosis(TB),caused by Mycobacterium tuberculosis complex(MTBC),is one of the chronically zoonotic infectious diseases.Currently,BCG is the unique vaccine against Mycobacterium tuberculosis;however,the effective protection for entire populations is highly controversial.The study of novel TB vaccine is a key in prevention of tuberculosis.The levels of immune response after vaccination are important for predicting and evaluating the efficacy of tuberculosis vaccine.Therefore,the immunogenicity analysis is crucial in the clinical evaluation of novel TB vaccines.In this article,the immunological evaluation methods and characteristics of novel TB vaccines in clinical assays were reviewed in order to provide reference to the researchers working in TB vaccine field.
作者
解慧聪
卢锦标
赵爱华
徐苗
XIE Hui-cong;LU Jin-biao;ZHAO Ai-hua;XU Miao(National Institute for Food and Drug Control,Beijing 102629,China;Key Laboratory of Research on Quality and Standardization of Biotech Pruducts,Chinese Academy of Medical Sciences,Beijing 100050,China)
出处
《中国新药杂志》
CAS
CSCD
北大核心
2019年第21期2617-2623,共7页
Chinese Journal of New Drugs
基金
中国医学科学院中央级公益性科研院所基本科研业务费(2019PT310024)
关键词
结核病
新型疫苗
免疫原性评价方法
免疫学特性
tuberculosis
novel vaccine
immunological evaluation methods
immunological characteristics