The histamine sensitization test is a widely used method for measuring the residual toxicity of pertussis toxin in acellular pertussis vaccines. Although it has been used as a routine assay for decades, the current protocols are difficult to standardize because the test results vary considerably and are based on several factors, including mouse strain, age and sex. In this study, we observed that mice of strains CD1, ddY and C57/BL6 were sufficiently sensitive to pertussis toxin among six mice strains tested and that aged male mice were more sensitive to pertussis toxin than younger or female mice. Using this animal model, we showed pertussis toxin dose-dependent responses in the two histamine sensitization test protocols based on either lethal end-point determination or mouse rectal temperature measurement. Sensitivity to pertussis toxin was further enhanced by the addition of lipopolysaccharide in both methods. With these improvements, pertussis toxin activity can be estimated more accurately and reproducibly using a reduced number of animals.

译文

组胺致敏试验是一种广泛用于测量百日咳毒素在无细胞百日咳疫苗中残留毒性的方法。尽管数十年来一直用作常规测定,但由于测试结果差异很大,并且基于多种因素,包括小鼠品系,年龄和性别,因此当前的方案难以标准化。在这项研究中,我们观察到CD1,ddY和C57/BL6菌株的小鼠对百日咳毒素足够敏感,并且老年雄性小鼠对百日咳毒素的敏感性高于年轻或雌性小鼠。使用该动物模型,我们基于致死终点测定或小鼠直肠温度测量,在两种组胺致敏试验方案中显示了百日咳毒素剂量依赖性反应。通过在两种方法中添加脂多糖,进一步增强了对百日咳毒素的敏感性。通过这些改进,可以使用减少数量的动物来更准确和可重复地估计百日咳毒素的活性。

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