Wang Y Y, Li J X, Cao J Q, Zhu F C
School of Public Health, Nanjing Medical University, Nanjing 211166, China.
Department of Vaccine Clinical Evaluation, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing 210009, China.
Zhonghua Yu Fang Yi Xue Za Zhi. 2019 Aug 6;53(8):851-854. doi: 10.3760/cma.j.issn.0253-9624.2019.08.010.
There are many limitations in evaluating vaccine efficacy by comparing the incidence of clinical endpoint events (such as morbidity, bacterial colonization) between the vaccine group and the control group. Therefore, the researchers put forward the concept of Surrogate of protection to predict vaccine protection with immunological indicators. In 2012, WHO put forward the immunological substitution endpoint of pneumococcal vaccine, using 0. 35 μg/ml as the protective antibody level of pneumococcal vaccine. But subsequent studies have found that using this threshold to assess all vaccine serotypes may not be accurate.
通过比较疫苗组和对照组之间临床终点事件(如发病率、细菌定植)的发生率来评估疫苗效力存在许多局限性。因此,研究人员提出了保护替代指标的概念,以利用免疫学指标预测疫苗的保护效果。2012年,世界卫生组织提出了肺炎球菌疫苗的免疫学替代终点,将0.35μg/ml作为肺炎球菌疫苗的保护性抗体水平。但随后的研究发现,使用这个阈值来评估所有疫苗血清型可能并不准确。