全球肿瘤疫苗临床转化现状分析

Worldwide Status of Clinical Translation in the Field of Tumor Vaccines

目的了解全球肿瘤疫苗领域的临床转化现状。方法采集ClinicalTrials.gov中全球肿瘤疫苗相关临床试验数据,利用文献计量学方法,从数量与时间变化趋势、国家分布、申办者分布及构成、临床试验机构分布、研究类型与方法、临床试验分期和适应证等角度分析肿瘤疫苗临床试验注册现状。结果全球肿瘤疫苗相关临床试验共1772项,主要开展于美国(1102项),申办者以企业、高校及科研院所为主。其中,绝大多数为实验性研究(1740项),且大多处于临床试验Ⅰ期和Ⅱ期;临床试验最常见的适应证为黑色素瘤(448项)、淋巴瘤/白血病(347项)和乳腺癌/肿瘤(347项)。截至检索日期(2021年1月28日),按临床试验注册数量,中国尚处于第二梯队(102项)。结论全球肿瘤疫苗领域临床转化日趋活跃,但大多数疫苗离正式上市尚早。

Objective To understand the worldwide status of clinical translation in the field of tumor vaccines.Methods Clinical trial data of tumor vaccines were collected from ClinicalTrials.gov,and the bibliometric method was used to analyze the status of clinical trial registrations of tumor vaccines from the perspectives of quantity and time trends,distribution of countries,distribution and composition of sponsors,distribution of clinical trial institutions,research types and methods,phases of clinical trials and indications of tumor vaccines.Results There were 1772 clinical trials related to tumor vaccines in the worldwide,mainly carried out in the United States(1102 items),mainly sponsored by enterprises,universities and scientific research institutes.Most clinical trials were experimental stud ies(1740 items),and most of them were in phaseⅠandⅡclinical trials.The most common indications of tumor vaccine in clinical trials were melanoma(448 items),lymphoma/leukemia(347 items),and breast cancer/tumor(347 items).As of the search date(January 28 th,2021),China was still in the second echelon(102 items)according to the number of clinical trial registrations.Conclusion The clinical translation in the field of tumor vaccines in the worldwide is increasingly active,but most vaccines are far from being officially launched.