肺炎球菌结合疫苗免疫学替代终点的研究进展

Research progress of the surrogate of protection of pneumococcal conjugate vaccine

与传统的以发病率或感染率为终点的疫苗效力评估临床试验比较,用免疫学替代终点评价疫苗保护作用的临床试验通常快速、简便、易于实施。2012年,WHO提出肺炎球菌结合疫苗的免疫学替代终点,将0.35 μg/ml作为肺炎球菌结合疫苗的保护性抗体水平。但后续研究发现,用这一界值来评估所有疫苗血清型的抗体水平可能并不准确。

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.