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

Jensen, Sten E.; Illigen, K.E.; Badsberg, Jens Henrik; Hasløv, K

doi:10.1016/j.biologicals.2011.09.015

Cited by 7 publications

(8 citation statements)

References 9 publications

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“…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.…”

Section: Kinetics Of Inactivationmentioning

confidence: 99%

Analytical Control Strategy of Bacterial Subunit Vaccines

Lee¹,

Turula

Powell³

et al. 2014

Vaccine Analysis: Strategies, Principles, and Control

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Section: Kinetics Of Inactivationmentioning

confidence: 99%

Analytical Control Strategy of Bacterial Subunit Vaccines

Lee¹,

Turula

Powell³

et al. 2014

Vaccine Analysis: Strategies, Principles, and Control

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“…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.…”

Section: Safety Of Vaccinesmentioning

confidence: 99%

Bioassays for evaluation of medical products derived from bacterial toxins

Sesardic¹

2012

Current Opinion in Microbiology

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“…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.…”

Section: Introductionmentioning

confidence: 99%

“…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.…”

Section: Introductionmentioning

confidence: 99%

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

Hoonakker

Arciniega

Hendriksen

2017

Human Vaccines & Immunotherapeutics

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The current test of acellular Bordetella pertussis (aP) vaccines for residual pertussis toxin (PTx) is the Histamine Sensitization test (HIST), based on the empirical finding that PTx sensitizes mice to histamine. Although HIST has ensured the safety of aP vaccines for years, it is criticized for the limited understanding of how it works, its technical difficulty, and for animal welfare reasons. To estimate the number of mice used worldwide for HIST, we surveyed major aP manufacturers and organizations performing, requiring, or recommending the test. The survey revealed marked regional differences in regulatory guidelines, including the number of animals used for a single test. Based on information provided by the parties surveyed, we estimated the worldwide number of mice used for testing to be 65,000 per year: ∼48,000 by manufacturers and ∼17,000 by national control laboratories, although the latter number is more affected by uncertainty, due to confidentiality policies. These animals covered the release of approximately 850 final lots and 250 in-process lots of aP vaccines yearly. Although there are several approaches for HIST refinement and reduction, we discuss why the efforts needed for validation and implementation of these interim alternatives may not be worthwhile, when there are several in vitro alternatives in various stages of development, some already fairly advanced. Upon implementation, one or more of these replacement alternatives can substantially reduce the number of animals currently used for the HIST, although careful evaluation of each alternative's mechanism and its suitable validation will be necessary in the path to implementation.

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

Cited by 7 publications

References 9 publications

Analytical Control Strategy of Bacterial Subunit Vaccines

Analytical Control Strategy of Bacterial Subunit Vaccines

Bioassays for evaluation of medical products derived from bacterial toxins

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

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