Mastrantonio P, Cerquetti M, Cardines R, Lande R, Ausiello C M, Cassone A
Laboratory of Bacteriology and Medical Mycology, Istituto Superiore di Sanità, Rome, Italy.
Biologicals. 1999 Jun;27(2):119-21. doi: 10.1006/biol.1999.0195.
Over the last few years our laboratory has been assessing the consistency of production of different batches of acellular pertussis vaccines to be marketed in Italy. Central to this is immunogenicity assay of the lots under control compared with those of a reference vaccine with documented clinical efficacy.However, the current assays based on the assessment of antibody (Ab) response in the mouse are unrelated to mechanisms of protection in children. The absence of a clear correlation between Ab responses and protection has also been documented in recent clinical trials. On this basis, we are currently considering the possibility of adding to the established criteria of immunogenicity in mice based on Ab responses, information from studies on cell-mediated immune responses to the vaccine constituents.
在过去几年中，我们实验室一直在评估意大利市场上不同批次无细胞百日咳疫苗生产的一致性。关键在于将受检批次的免疫原性测定结果与具有已证实临床疗效的参考疫苗的结果进行比较。然而，目前基于小鼠抗体（Ab）反应评估的检测方法与儿童的保护机制无关。近期临床试验也证明了抗体反应与保护作用之间缺乏明确的相关性。在此基础上，我们目前正在考虑在基于抗体反应的小鼠免疫原性既定标准中，加入有关疫苗成分细胞介导免疫反应研究的信息。
