Improved protocols for histamine sensitization testing of acellular pertussis vaccines

H Oh, J Joung, BG Kim, KT Nam, SH Hong, HC Song… - Vaccine, 2012 - Elsevier
The histamine sensitization test is a widely used method for measuring the residual toxicity
of pertussis toxin in acellular pertussis vaccines. Although it has been used as a routine …

[HTML][HTML] Towards replacement of the acellular pertussis vaccine safety test: Comparison of in vitro cytotoxic activity and in vivo activity in mice

LD Wagner, LJ Corvette, MM Ngundi, DL Burns - Vaccine, 2017 - Elsevier
Because of the exquisite sensitivity of the murine histamine sensitization test (HIST) in
detecting minute amounts of active pertussis toxin (PTx), this animal-based test has been …

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

SE Jensen, KEE Illigen, JH Badsberg, KR Hasløv - Biologicals, 2012 - Elsevier
Currently, an assay based on fatal sensitization of mice to histamine challenge is widely
used for testing absence of residual pertussis toxin in acellular pertussis containing …

[PDF][PDF] Alternative safety testing strategies for acellular pertussis vaccines

R Isbrucker - ALTEX Proceedings, 2012 - proceedings.altex.org
The mouse histamine sensitization test (HIST) is the currently accepted regulatory method
used to monitor residual pertussis toxin (PTx) activity in acellular pertussis vaccines. This …

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

CT Yuen, Y Horiuchi, C Asokanathan, S Cook… - Vaccine, 2010 - Elsevier
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 …

The cAMP assay: a functional in vitro alternative to the in vivo Histamine Sensitization test

ME Hoonakker, N Ruiterkamp, CFM Hendriksen - Vaccine, 2010 - Elsevier
Safety requirements stipulate the performance of the in vivo Histamine Sensitization (HS)
test for quality control of acellular pertussis (aP) vaccines. For reasons of reproducibility and …

Report on the international workshop on alternatives to the murine histamine sensitization test (HIST) for acellular pertussis vaccines: State of the science and the path …

R Isbrucker, J Arciniega, R McFarland, JM Chapsal… - Biologicals, 2014 - Elsevier
Regulatory authorities require safety and potency testing prior to the release of each
production lot of acellular pertussis (aP)-containing vaccines. Currently, the murine …

Target alternative vaccine safety testing strategies for Pertussis toxin

JL Arciniega, L Corvette, H Hsu, F Lynn, T Romani… - Procedia in …, 2011 - Elsevier
All acellular pertussis (aP) vaccines in use contain chemically inactivated pertussis toxin
(PT). The finding that mice, naturally resistant to the effects of histamine, become sensitive …

[HTML][HTML] Reporter cell lines for detection of pertussis toxin in acellular pertussis vaccines as a functional animal-free alternative to the in vivo histamine sensitization …

ME Hoonakker, LM Verhagen, L van der Maas… - Vaccine, 2017 - Elsevier
Detoxified pertussis toxin (pertussis toxoid) is a major antigen in acellular pertussis
vaccines. Testing these vaccines on the presence of residual pertussis toxin (PTx) and …

Highly sensitive histamine-sensitization test for residual activity of pertussis toxin in acellular pertussis vaccine

M Ochiai, A Yamamoto, M Kataoka, H Toyoizumi… - Biologicals, 2007 - Elsevier
Histamine-sensitization test method based on histamine-sensitizing death is widely used for
controlling residual activity of pertussis toxin in acellular pertussis vaccines. The test method …