Collaborative study on test systems to assess toxicity of whole cell pertussis vaccine

Biologicals : Journal of the International Association of Biological Standardization
I van Straaten-van de KappelleH J van de Donk

Abstract

A collaborative study has been carried out to establish the precision and accuracy of five test systems for the assessment of the toxicity of whole cell pertussis vaccine. To this end, six vaccines, including both "normal" and "abnormal" products with respect to arbitrary levels of Pertussis toxin and/or potency were tested. The study included in vivo test systems as the Mouse Weight Gain (MWG) test; the current WHO-recommended bioassay to evaluate overall pertussis toxicity and four specific test systems; the Leukocytosis Promotion (LP) test, the Histamine Sensitization (HS) test and in vitro the Chinese Hamster Ovary (CHO) clustering test to estimate pertussis toxin (PT) levels, and the Limulus Amoebocyte Lysate (LAL) test to evaluate endotoxin levels. In addition, participants were also asked to estimate potency by the Mouse Protection test according to Kendrick (MP). Fourteen laboratories in various countries participated in the study. In almost all participating laboratories, the MWG test was not very accurate in evaluating the overall toxicity of whole cell pertussis vaccines. In addition, statistical significant interlaboratory variation was frequently seen. The specific toxicity tests (LP, HS, CHO and LAL test) appeared...Continue Reading

Citations

May 23, 2012·Biologicals : Journal of the International Association of Biological Standardization·Christina BacheThomas Montag
Nov 28, 2009·Vaccine·Marieke E HoonakkerCoenraad F M Hendriksen
Aug 15, 2012·Biologicals : Journal of the International Association of Biological Standardization·Dorothy XingYoshinobu Horiuchi
Feb 21, 2014·Human Vaccines & Immunotherapeutics·Stefan F C VaessenArnoud M Akkermans
Mar 10, 2001·Biologicals : Journal of the International Association of Biological Standardization·C CanthabooM Corbel
Jul 8, 2000·Biologicals : Journal of the International Association of Biological Standardization·A van der ArkC Hendriksen
Dec 22, 1999·Biologicals : Journal of the International Association of Biological Standardization·M J CorbelD J Hockley
Sep 1, 2017·Human Vaccines & Immunotherapeutics·Marieke HoonakkerCoenraad Hendriksen
Nov 8, 2017·Analytical Biochemistry·Catpagavalli AsokanathanChun-Ting Yuen

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