An alternative temperature-based histamine-sensitisation test for absence of residual pertussis toxin in acellular pertussis vaccines

Pharmeur Bio Sci Notes. 2010 Apr;2010(1):73-4.

Abstract

As an extension of the BSP076 study (see the article 'Collaborative Study for the Standardisation of the Histamine Sensitizing Test in Mice and the CHO Cell-based Assay for the Residual Toxicity Testing of Acellular Pertussis Vaccines (BSP076)', page 51 of this issue of Pharmeuropa Bio & Scientific Notes), it was decided to publish the following experimental method for the temperature-based histamine-sensitisation test, validated at the SSI (Statens Serum Institut, Denmark), as a working basis for the growth of the method in individual laboratories.

Publication types

  • Letter

MeSH terms

  • Animal Use Alternatives
  • Animals
  • Biological Assay / methods*
  • Biological Assay / standards
  • Body Temperature* / drug effects
  • Calibration
  • Dose-Response Relationship, Drug
  • Female
  • Histamine / administration & dosage
  • Histamine / immunology
  • Histamine / toxicity*
  • Laboratories / standards
  • Mice
  • Mice, Inbred C57BL
  • Pertussis Toxin / analysis*
  • Pertussis Toxin / immunology
  • Pertussis Vaccine / immunology
  • Pertussis Vaccine / standards*
  • Pertussis Vaccine / toxicity
  • Reference Standards
  • Thermography
  • Toxicity Tests / methods*
  • Toxicity Tests / standards
  • Vaccines, Acellular / immunology
  • Vaccines, Acellular / standards*
  • Vaccines, Acellular / toxicity

Substances

  • Pertussis Vaccine
  • Vaccines, Acellular
  • Histamine
  • Pertussis Toxin