[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 …

[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 …

[HTML][HTML] Prevalidation of the cAMP-PTx reporter assay for quantitative assessment of pertussis toxin activity

L de Brouwer, D David, ME Ballestas, A Sloots… - Vaccine, 2022 - Elsevier
Testing for inactivation of pertussis toxin and reversion to toxicity in aP vaccines has
historically relied on the murine histamine sensitization test, that lacks mechanistic …

[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 …

Modified binding assay for improved sensitivity and specificity in the detection of residual pertussis toxin in vaccine preparations

RA Isbrucker, A Bliu, F Prior - Vaccine, 2010 - Elsevier
A binding assay was recently published that differentiates between pertussis toxin (PTx) and
the pertussis toxoid (PTd) used in acellular pertussis vaccines based on the selective …

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 …

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 …

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 …

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 …

Toward a mechanism-based in vitro safety test for pertussis toxin

SFC Vaessen, MWP Bruysters… - Human vaccines & …, 2014 - Taylor & Francis
Pertussis vaccines are routinely administered to infants to protect them from whooping
cough. Still, an adequate safety test for pertussis toxin (PT), one of the main antigens in …