Nonclinical vaccine safety evaluation: advantages of continuous temperature monitoring using abdominally implanted data loggers
Article first published online: 8 MAR 2012
Copyright © 2012 John Wiley & Sons, Ltd.
Journal of Applied Toxicology
Volume 33, Issue 6, pages 521–526, June 2013
How to Cite
Kaaijk, P., van der Ark, A. A. J., van Amerongen, G. and van den Dobbelsteen, G. P. J. M. (2013), Nonclinical vaccine safety evaluation: advantages of continuous temperature monitoring using abdominally implanted data loggers. J. Appl. Toxicol., 33: 521–526. doi: 10.1002/jat.2720
- Issue published online: 22 APR 2013
- Article first published online: 8 MAR 2012
- Manuscript Revised: 22 DEC 2011
- Manuscript Accepted: 22 DEC 2011
- Manuscript Received: 2 DEC 2011
- body temperature;
- data logger;
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 4 h after vaccination, and this time point was subsequently applied in the toxicology study. Measured body temperature values at the selected time point of 4 h 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. Copyright © 2012 John Wiley & Sons, Ltd.