个体化细胞及核酸治疗性肿瘤疫苗临床药效学研究概况  

Survey on clinical pharmacodynamics of personalized cells and nucleic acid therapeutic tumor vaccines

作　　者：贺庆[1] 张横(综述)[1] 王军志(审校)[1] HE Qing;ZHANG Heng;WANG Jun-zhi(National Institutes for Food and Drug Control,State Key Laboratory for Evaluation and Standardization of Innovative Vaccines and Biotechnology Products,Beijing 102629,China)

机构地区：[1]中国食品药品检定研究院创新疫苗及生物技术产品评价与标准化国家重点实验室,北京102629

出　　处：《中国生物制品学杂志》2022年第8期1006-1012,共7页Chinese Journal of Biologicals

基　　金：国家科技重大专项重大新药创制项目(2018ZX09101001).

摘　　要：患者肿瘤异质性和人白细胞抗原(human leukocyte antigen,HLA)异质性是影响肿瘤疫苗药效作用的关键因素,研发个体化治疗性肿瘤疫苗已成为肿瘤疫苗未来发展的方向。细胞疫苗含有肿瘤细胞的所有抗原,设计和生产疫苗前无需对这些抗原进行系统而繁琐的鉴定,制备时间较短;核酸疫苗设计灵活,可同时编码肿瘤抗原和免疫调节分子,易于量产。针对这两类疫苗的特点,开发个体化细胞及核酸治疗性肿瘤疫苗已成为研究热点。本文就2002—2020年期间个体化细胞及核酸治疗性肿瘤疫苗的Ⅰ~Ⅲ期临床药效学研究概况作一综述,以期为该类疫苗的相关研发和评价监管提供参考。In view of the effect of tumor heterogeneity and human leukocyte antigen(HLA)heterogeneity on the efficacy of tumor vaccine,the development of personalized therapeutic tumor vaccines has become the future direction in exploiting tumor vaccines.Cell vaccines contain all the tumor cell antigens needing no systematic and complicated identification before the design and production of vaccine,which is time-saving in preparation.Nucleic acid vaccines are flexible in design,which can encode both tumor antigens and immunoregulatory molecules,and are easy to be produced in a large quantity.According to the characteristics of the two kinds of vaccines,the development of personalized cells and nucleic acid therapeutic tumor vaccines has become a research hotspot.This paper summarizes the phasesⅠtoⅢclinical pharmacodynamics of personalized cells and nucleic acid therapeutic tumor vaccines from 2002 to 2020 so as to provide a reference for the development,evaluation and monitoring of the vaccines.

关 键 词：个体化疫苗 细胞疫苗 核酸疫苗 治疗性肿瘤疫苗 药效学 

分 类 号：R979.1[医药卫生—药品]