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 … toxicity of pertussis toxin in
acellular pertussis vaccines. … current protocols are difficult to standardize because the test results …

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
… islet cells; and (3) increased sensitivity to histamine in experimental animals. In terms of its
… a single alternative test method protocol will be appropriate for all aP vaccines. Adoption of …

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
… leukocytosis, histamine sensitisation, increased insulin production … PT also has been reported
to increase blood brain barrier … after receiving the test materials and protocols due to staff …

[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 …

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
pertussis vaccines for evaluating improvement of its quality. Histamine-sensitization (HS)
test method based on histamine-… death in mice was prescribed in the WHO guidelines as an …

Workshop on animal free detection of pertussis toxin in vaccines–alternatives to the histamine sensitisation test

C Bache, M Hoonakker, C Hendriksen, KH Buchheit… - Biologicals, 2012 - Elsevier
… safety testing for acellular pertussis vaccines, the “Histamine … WHO guidelines and the
European Pharmacopoeia [4], [5]. … -based test, the cAMP-assay, which assesses the increase of …

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)… and optimization protocols
of the vaccine production processes. … We use cookies to improve your website experience. To …

[PDF][PDF] … study for the standardisation of the histamine sensitizing test in mice and the CHO cell-based assay for the residual toxicity testing of acellular pertussis vaccines

D Xing, A Maes, ME Behr-Gross, A Costanzo… - Pharmeur Bio Sci …, 2010 - Citeseer
… for acellular pertussis-based combination vaccines in order … inter-laboratory variations can
be improved by the use of a … , calibrated in IU, can increase comparability of results among …

[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 …

[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 … or more HIST protocols may
have to be used when vaccines from … ment to reduce the variability and improve the sensitivity. …