An in vitro assay system as a potential replacement for the histamine sensitisation test for acellular pertussis based combination vaccines

Abstract The histamine sensitisation test (HIST) for pertussis toxin is currently an official batch release test for acellular pertussis containing combination vaccines in Europe and North America. However, HIST, being a lethal endpoint assay, often leads to repeated tests due to large variations in...

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Bibliographic Details
Published in:Vaccine 2010-05, Vol.28 (21), p.3714-3721
Main Authors: Yuen, Chun-Ting, Horiuchi, Yoshinobu, Asokanathan, Catpagavalli, Cook, Sarah, Douglas-Bardsley, Alexandra, Ochiai, Masaki, Corbel, Michael, Xing, Dorothy
Format: Article
Language:English
Subjects:
Acellular pertussis vaccine
ADP-Ribosylation Factors - analysis
Allergy and Immunology
Animal Testing Alternatives - methods
Animals
Applied microbiology
Biological and medical sciences
Biological Assay - methods
Carbohydrate-binding
Carbohydrates - analysis
Cell culture
Chromatography, High Pressure Liquid
Enzymatic-HPLC assay
Female
Fundamental and applied biological sciences. Psychology
Gene expression
Histamine
Histamine - analysis
Histamine sensitisation assay
Liquid chromatography
Mice
Microbiology
Models, Theoretical
Pertussis Vaccine - immunology
Proteins
Regression Analysis
Rodents
Temperature measurement
Toxins
Vaccines
Vaccines, Acellular - immunology
Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects)
Vaccines, Combined
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Summary:Abstract The histamine sensitisation test (HIST) for pertussis toxin is currently an official batch release test for acellular pertussis containing combination vaccines in Europe and North America. However, HIST, being a lethal endpoint assay, often leads to repeated tests due to large variations in test performance. Although a more precise HIST test based on measurement of temperature reduction after the histamine challenge is used in Asian countries, this test still uses animals. An in vitro test system based on a combination of enzyme coupled-HPLC and carbohydrate-binding assays with results analysed by a mathematical formula showed a good agreement with the in vivo HIST results based on measurement of temperature reduction after histamine challenge. The new in vitro test system was shown to be a potential alternative to the current in vivo HIST.
ISSN:0264-410X
1873-2518
DOI:10.1016/j.vaccine.2010.03.009