[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 …

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 …

Evaluation of an in vitro assay system as a potential alternative to current histamine sensitization test for acellular pertussis vaccines

D Xing, CT Yuen, C Asokanathan, P Rigsby, Y Horiuchi - Biologicals, 2012 - Elsevier
The histamine sensitization test (HIST) is a lethal test for batch release of acellular pertussis
or its combination vaccines (ACV). Large numbers of animals have been used and it is …

Safety testing of acellular pertussis vaccines: Use of animals and 3Rs alternatives

M Hoonakker, J Arciniega… - Human Vaccines & …, 2017 - Taylor & Francis
The current test of acellular Bordetella pertussis (aP) vaccines for residual pertussis toxin
(PTx) is the Histamine Sensitization test (HIST), based on the empirical finding that PTx …

Assays for determining pertussis toxin activity in acellular pertussis vaccines

K Markey, C Asokanathan, I Feavers - Toxins, 2019 - mdpi.com
Whooping cough is caused by the bacterium Bordetella pertussis. There are currently two
types of vaccines that can prevent the disease; whole cell vaccines (WCV) and acellular …

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

SE Jensen, EI KE, KR Hasløv - Pharmeuropa bio & Scientific Notes, 2010 - europepmc.org
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 …

An international collaborative study of the effect of active pertussis toxin on the modified Kendrick test for acellular pertussis vaccines

D Xing, RG Das, A Douglas-Bardsley, C Asokanathan… - Biologicals, 2014 - Elsevier
Speculation that the Japanese modified intra-cerebral challenge assay, which is used in
several countries for control of acellular pertussis vaccines, depends on the presence of …

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

I van Straaten-van de Kappelle, JW van der Gun… - Biologicals, 1997 - Elsevier
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 …

[HTML][HTML] Alternatives to HIST for acellular pertussis vaccines: progress and challenges in replacement: Report on an international workshop

J Arciniega, L Wagner, R Prymula, P Sebo… - Pharmeuropa bio & …, 2016 - ncbi.nlm.nih.gov
Abstract The 'International Workshop on Alternatives to the Murine Histamine Sensitization
Test for Acellular Pertussis Vaccines: Progress and Challenges in the Replacement of …

Retrospective analysis of the results of acellular pertussis vaccine toxicity tests performed in Korea

H Oh, J Joung, B Kim, H Lee, W Lee… - Human Vaccines & …, 2012 - Taylor & Francis
Specific toxicity test is a major quality control test for acellular pertussis (aP) vaccines
performed by manufacturers and regulatory authorities. The 'mouse body weight gain test …