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首页> 外文期刊>Journal of applied toxicology >Nonclinical vaccine safety evaluation: Advantages of continuous temperature monitoring using abdominally implanted data loggers
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Nonclinical vaccine safety evaluation: Advantages of continuous temperature monitoring using abdominally implanted data loggers

机译：非临床疫苗安全性评估：使用腹部植入式数据记录仪进行连续温度监测的优势

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Fever has been reported as the most common adverse event after vaccination in infants and children. For this reason it is important that, prior to clinical testing of a new vaccine, change in body temperature following vaccination is tested carefully in nonclinical animal studies. Since both the timing and the height of the temperature peak after vaccination may differ from vaccine to vaccine, it is important that the time point for body temperature measurement should be chosen on a case-by-case basis with sufficient knowledge of the specific vaccine. In order to determine the best time point for rectal body temperature measurement after vaccination with a new vaccine candidate against N. meningitidis serogroup B, to be applied in a formal Good Laboratory Practice (GLP) toxicology study, miniature temperature data loggers were implanted into the peritoneal cavity of rabbits. The continuous body temperature monitoring appeared to give a complete picture of the entire body temperature kinetics after vaccination. The body temperature peaked at 4h after vaccination, and this time point was subsequently applied in the toxicology study. Measured body temperature values at the selected time point of 4h after vaccination were comparable in the continuous temperature setting and in the formal toxicology study, i.e. rectal temperature measurement at one time point. In the present study implanted temperature loggers were successfully used to define an adequate time point to be applied in determining rectal body temperature in a formal GLP toxicology study with a new vaccine candidate.
机译：据报道，发烧是婴儿和儿童接种疫苗后最常见的不良事件。因此，重要的是，在进行新疫苗的临床测试之前，必须在非临床动物研究中仔细测试疫苗接种后的体温变化。由于疫苗接种后温度高峰的时间和高度可能因疫苗而异，因此重要的是，应在充分了解具体疫苗的情况下，逐案选择测量体温的时间点。为了确定接种新的抗脑膜炎双球菌血清群B的候选疫苗接种后的直肠体温测量的最佳时间点，以将其用于正式的良好实验室规范（GLP）毒理学研究，将微型温度数据记录仪植入人体兔腹腔。连续的体温监测似乎可以提供疫苗接种后整个体温动力学的完整图像。疫苗接种后4h体温达到峰值，随后将该时间点应用于毒理学研究。疫苗接种后4小时选定时间点的体温测量值在连续温度设定和正式毒理学研究（即在某一时间点进行直肠温度测量）方面具有可比性。在本研究中，植入式温度记录仪已成功用于定义适当的时间点，以在正式的GLP毒理学研究中使用新的候选疫苗确定直肠体温。

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