[PDF][PDF] In search of acceptable alternatives to the murine histamine sensitisation test (HIST): what is possible and practical

L Wagner, R Isbrucker, C Locht, J Arciniega… - Pharmeur Bio Sci …, 2016 - researchgate.net
test, based on the induction of increased sensitivity to … of pertussis toxin activity in acellular
pertussis vaccines’), to … a set of vaccines for testing, establish a protocol for spiking these …

[PDF][PDF] Transferability study of CHO cell clustering assays for monitoring of pertussis toxin activity in acellular pertussis vaccines

R Isbrucker, A Daas, L Wagner… - Pharmeur Bio Sci …, 2016 - researchgate.net
… if the use of a standardised protocol could improve the inter-… histamine sensitizing test in
mice and the CHO cell-based assay for the residual toxicity testing of acellular pertussis vaccines

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

ME Hoonakker, LM Verhagen, L van der Maas… - Vaccine, 2017 - Elsevier
… Current application of this test is limited to bulk products, … parameter, which might increase
variability in test outcomes. … To improve sensitivity and reduce variability of this assay, we …

[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
… for the histamine sensitisation test (HIST) for acellular pertussis … of new or improved pertussis
vaccines, development and … Protocols for pertussis vaccination vary among countries in …

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

M Hoonakker, J Arciniega… - Human Vaccines & …, 2017 - Taylor & Francis
pertussis toxin (PTx) is the Histamine Sensitization test (HIST)… Remarkably, the incidence of
pertussis has increased since … and optimization protocols of the vaccine production processes…

[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
sensitivity of the murine histamine sensitization test (HIST) in detecting minute amounts of
active pertussis toxin (PTx), this animal-based testincreased sensitivity of the mice to histamine

Assays for determining pertussis toxin activity in acellular pertussis vaccines

K Markey, C Asokanathan, I Feavers - Toxins, 2019 - mdpi.com
… use of ACVs the lethal histamine sensitization test (HIST) in mice … assay protocols were not,
however, suitable for testing … was found that the LP test performed better than HIST and CHO …

[HTML][HTML] Collaborative study for the calibration of the replacement International Standard for pertussis toxin for use in histamine sensitisation and CHO cell clustering …

A Douglas-Bardsley, C Asokanathan, S Tierney… - Biologicals, 2019 - Elsevier
… for the quality control of pertussis vaccines. Stocks of the first … the induction of increased
sensitivity to histamine by active PT… estimate of the PT activity in a test vaccine [9,10]. Both forms …

[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
… and global replacement of the histamine sensitization test. … form the second generation of
pertussis vaccines to protect … The HIST is based on increased sensitivity to histamine upon …

[PDF][PDF] Journal of Vaccines & Vaccination

CT Yuen, C Asokanathan, A Douglas-Bardsley… - 2017 - researchgate.net
… worldwide and the histamine sensitisation test (HIST) is … dilution of vaccines would help
to increase test sensitivity. Spiking … to HIST for batch-release of acellular pertussis vaccines. …