个体化肽治疗性肿瘤疫苗的临床药效学研究分析  

Clinical pharmacodynamics analysis of personalized peptide therapeutic tumor vaccines

作　　者：贺庆[1] 高华[1] 王军志[1] HE Qing;GAO Hua;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：《中国新药杂志》2021年第19期1729-1737,共9页Chinese Journal of New Drugs

基　　金：国家“重大新药创制”科技重大专项资助项目(2018ZX09101-001):创新生物技术药评价及标准化关键技术研究。

摘　　要：个体化肽治疗性肿瘤疫苗是根据患者肿瘤异质性和人白细胞抗原异质性制备的一种精准医疗产品,具有抑瘤作用特异性强、不良反应少、抗原序列明确、易于制备和质控、经济成本相对较低等特点,此类疫苗已成为研发肿瘤疫苗的热点。本文分析总结了近20年来个体化肿瘤相关抗原肽和个体化肿瘤新抗原肽治疗性肿瘤疫苗的Ⅰ~Ⅲ期临床药效学研究概况,以期为进行此类疫苗的研发和评价提供参考。目前,临床患者对个体化肿瘤相关抗原肽治疗性肿瘤疫苗产生特异性体液和细胞免疫反应率分别约为70%和60%,个体化肿瘤新抗原肽治疗性肿瘤疫苗中约60%的新抗原可诱导患者产生特异性细胞免疫反应,这2类疫苗最常见的不良反应为注射部位皮肤反应,整体具有较好的免疫原性和耐受性。Personalized peptide therapeutic tumor vaccine is a kind of precision medical product prepared according to the tumor heterogeneity and human leukocyte antigen heterogeneity in patients.It has strong anti-tumor specificity,low toxic and side effects,definite antigen sequence,and is easy to be prepared and controlled.Additionally,the economic cost is relatively low.This kind of vaccine has become a hot spot in tumor vaccine development.This paper analyzes and summarizes the Ⅰ~Ⅲ phase clinical pharmacodynamics researches of personalized tumor-associated antigen peptide therapeutic tumor vaccines and personalized tumor neoantigen peptide therapeutic tumor vaccines in the recent 2 decades,in order to provide a reference for the development and evaluation of such vaccines.At present,the specific humoral and cellular immune response rates of patients vaccinated with personalized tumor-associated peptide therapeutic tumor vaccines are about 70% and 60%,respectively.The specific cellular immune response can be induced in patients by about 60% of the neoantigens in personalized tumor neoantigen peptide therapeutic tumor vaccines.The most common adverse reaction of the two types of vaccines was skin reaction at the injection site,both of which generally had good immunogenicity and tolerability.

关 键 词：个体化治疗性肿瘤疫苗 肽疫苗 临床药效学 肿瘤相关抗原 肿瘤新抗原 

分 类 号：R979.1[医药卫生—药品]