Specificity and detection limit of a dermal temperature histamine sensitization test for absence of residual pertussis toxin in vaccines

Analytical Control Strategy of Bacterial Subunit Vaccines

“…Jensen et al (2012) developed a dermal temperature-based HIST assay and estimated a sensitivity of 5 ng PT per human dose of pertussis vaccine using this modified procedure. In this method, the change in body temperature after histamine challenge is measured and sensitized mice show a sharp decrease in body temperature following histamine challenge.…”

Bioassays for evaluation of medical products derived from bacterial toxins

“…Safety tests for bacterial vaccines comprise the administration of final product or product intermediate to sensitive animals and observation for any signs of specific or non-specific adverse effects and signs of ill-health, toxininduced ill-health during the specified time or changes in dermal temperature for example, pertussis toxaemia [18,19]. For general effects and as part of confirming compliance with general safety test monitoring changes in weight between test and reference controls is performed and or weight gain in animals over a defined period of time.…”

Safety testing of acellular pertussis vaccines: Use of animals and 3Rs alternatives

“…Similar to the first version, the second version is based on PTx-induced histamine sensitization; however, whether the level of PTx exceeds a specified threshold is determined by assessing a decrease in body temperature, rather than death of the mice. 36 The third version uses the same principle as the second version, but measures the actual level of PTx by comparing the associated decrease in body temperature caused by several doses of the vaccine on test, relative to a toxicity reference preparation. For the second and third versions, body temperature can be monitored by a rectal probe or by infrared detection of the dermal temperature.…”

“…As mentioned before, the presence of PTx can be assessed by changes in body temperature, a method applied in some Asian countries and by SSI in Denmark. 36 A drop in rectal or dermal temperature as a consequence of PTx is assessed within 30 minutes of histamine challenge. 37 Application of this method might therefore reduce the duration of potential suffering.…”