疫苗免疫学替代终点研究进展

Research Progress of Vaccine Surrogate of Protection

在疫苗临床研究领域,与疫苗保护作用相关的免疫学替代终点研究非常有意义。与观察临床终点的现场临床试验相比,免疫学替代终点的应用能够显著降低研究人群的样本量,缩短随访时间,从而推动新疫苗的研发、评价、审批和应用。目前,经多项研究的不断探讨,已有10多种疫苗如黄热病疫苗、流感疫苗、肺炎疫苗等建立了免疫学替代终点。现回顾综述疫苗免疫学替代终点发展史,讨论发展中遇到的问题、挑战以及未来的研究方向。

In the context of vaccine clinical trial,the research about vaccine-induced surrogate of protection is of great significance.Compared with field efficacy trials which determine clinical endpoints by observation,vaccine trials using immunological endpoints could reduce either sample size or duration,which would significantly promote the development,evaluation,licensure and utilization of new candidate vaccines.Surrogate of protection of some vaccines such as influenza,yellow fever and pneumonia vaccine,etc.have been established.Through reviewing the development of surrogate of protection of vaccine,we will discuss issues and challenges remaining to be investigated in the future.