[摘要] 肿瘤疫苗（tumor vaccine）作为一种举足轻重的免疫疗法，已日益在恶性肿瘤治疗中显示其重要价值。然而，针对肿瘤相关抗原（tumor associated antigen，TAA）的传统疫苗由于免疫耐受、诱发自身免疫疾病的风险，难以在临床大规模推广。来源于肿瘤体细胞突变、异于正常细胞的新抗原（neoantigen）近年来被认为是理想的疫苗靶点。在测序的基础上发展而来的个体化新抗原疫苗（personalized neoantigen vaccine）特异性靶向新抗原，有望成为精准治疗肿瘤的重要突破口。本文围绕个体化新抗原疫苗的概念、特点、制备流程及临床试验等方面的研究进展进行详细阐述，并对其临床转化面临的机遇与挑战作一展望。

[Abstract] As one of the pivotal immunotherapies, tumor vaccine has increasingly shown its benefits in the treatment of malignant tumors.However, traditional vaccines targeting tumor associated antigen (TAA) are difficult to be promoted on a large scale in clinic, due to immune tolerance and the risk of inducing autoimmune disease. Neoantigen, which doesn’t present in normal cells and originates from tumor somatic mutations, is considered as ideal target for vaccines recently. Personalized neoantigen vaccine developed on the basis of sequencing, which specifically targets neoantigens, is expected to become an important breakthrough in precision medicine of cancer.This paper will elaborate on the concept, characteristics, preparation process and clinical trials of personalized neoantigen vaccine,and we will also discuss the opportunities and challenges that might be encountered during its clinical transformation.

国家自然科学基金资助项目（No. 81372249），广州市健康医疗协同创新重大专项（No. 201704020216），广东省科技发展专项资金（No. 2016A020213005），广东省自然科学基金- 博士启动纵向协同（No. 2017A030310301），南方医科大学临床研究启动项目（No. LC2016ZD027）