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首页> 外文期刊>Human vaccines >Transferability of dermal temperature histamine sensitization test for estimation of pertussis toxin activity in vaccines.
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Transferability of dermal temperature histamine sensitization test for estimation of pertussis toxin activity in vaccines.

机译：皮肤温度组胺敏化试验的可转移性，用于评估疫苗中的百日咳毒素活性。

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All current acellular pertussis vaccines (ACVs) contain detoxified pertussis toxin (PT) as a major component. An essential part of the safety evaluation of these vaccines, required by regulatory authorities, is to monitor their active PT content and to check for reversion to toxicity of the detoxified PT. Although various in vitro tests are under investigation, the only practicable means for detecting active PT at present is the histamine sensitization test. The methods given in the European Pharmacopoeia and in the US Pharmacopoeia are based on recording a binary response to histamine challenge (using a lethal end point). A more sensitive method based on measurement of rectal temperature is given in the Japanese Minimum Requirements for Biological Products. More recently, a refinement of this method based on dermal temperature measurement has been developed for ACVs in combination with diphtheria and tetanus vaccines (DTaP). We show that this method also can be used for more complex combination vaccines and is readily transferable. Furthermore use of dermal temperature provides a more precise quantitative estimate of toxin activity than the binary response, leading to an increase in information from a specified number of animals, or allowing a reduction in the number of animals required. We suggest that, pending the development of an alternative in vitro replacement method, the temperature based method may serve as an intermediate solution to the estimation of PT activity giving a precise estimate with reduction in animal numbers.
机译：当前所有的脱细胞百日咳疫苗（ACV）都含有脱毒的百日咳毒素（PT）作为主要成分。监管机构要求对这些疫苗进行安全性评估的重要部分是监视其活性PT含量并检查解毒PT的毒性回复。尽管正在研究各种体外测试，但是目前用于检测活性PT的唯一可行方法是组胺敏化测试。欧洲药典和美国药典中给出的方法均基于记录对组胺激发的二元反应（使用致死终点）。日本生物产品最低要求中提供了一种基于直肠温度测量的更灵敏的方法。最近，针对白喉和破伤风疫苗（DTaP）的ACV，已经开发了基于真皮温度测量的此方法的改进方法。我们表明，该方法还可以用于更复杂的组合疫苗，并且易于转移。此外，与二元反应相比，使用真皮温度可提供更精确的毒素活性定量估计值，从而增加指定数量动物的信息，或减少所需动物的数量。我们建议，在开发替代的体外替代方法之前，基于温度的方法可作为PT活性估算的中间方案，从而提供精确的估算并减少动物数量。

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