title: Alternatives to HIST for acellular pertussis vaccines: progress and challenges in replacement.
abstract: The 'International Workshop on Alternatives to the Murine Histamine Sensitization Test for Acellular Pertussis Vaccines: Progress and Challenges in the Replacement of HIST' was held on 24 August 2014, in Prague, Czech Republic, as a satellite meeting to the 9th World Congress on Alternatives and Animal Use in the Life Sciences. Participants discussed the progress and challenges associated with the development, validation, and implementation of in vitro assays as replacements for the histamine sensitisation test (HIST) for acellular pertussis vaccines. Discussions focused on the consistency approach, the necessary framework for regulatory acceptance of a harmonised method, and recent international efforts towards the development of in vitro assays to replace the HIST. Workshop participants agreed that acceptable alternatives to the HIST should be based on ADP ribosylation-mediated cell intoxication and therefore that the CHO cell clustering assay, which measures cell intoxication, should be further pursued and developed as a possible replacement for the HIST. Participants also agreed to continue ongoing multinational discussions involving national and international standardisation authorities to reach consensus and to organise collaborative studies in this context for assay characterisation and calibration of reference materials.
authors: US FDA.
authors: J
authors: J
authors: Arciniega
authors: US FDA.
authors: L
authors: L
authors: Wagner
authors: UH.
authors: R
authors: R
authors: Prymula
authors: ASCR.
authors: P
authors: P
authors: Sebo
authors: Health Canada.
authors: R
authors: R
authors: Isbrucker
authors: GSK.
authors: B
authors: B
authors: Descampe
authors: Sanofi Pasteur.
authors: J M
authors: JM
authors: Chapsal
authors: EDQM.
authors: A
authors: A
authors: Costanzo
authors: IntraVacc.
authors: C
authors: C
authors: Hendriksen
authors: IntraVacc.
authors: M
authors: M
authors: Hoonaker
authors: Sanofi Pasteur.
authors: S
authors: S
authors: Nelson
authors: NC3Rs.
authors: K
authors: K
authors: Lidster
authors: NIEHS.
authors: W
authors: W
authors: Casey
authors: ILS.
authors: D
authors: D
authors: Allen
mesh_terms: D000818:Animals; D016466:CHO Cells; D006224:Cricetinae; D003412:Cricetulus; D018153:Czech Republic; D004493:Education / Q000379:methods / Q000639:trends; D006632:Histamine / Q000008:administration & dosage*; D006801:Humans; D051379:Mice; D037342:Pertussis Toxin / Q000627:therapeutic use*; D010567:Pertussis Vaccine / Q000627:therapeutic use*; D022282:Vaccines, Acellular / Q000627:therapeutic use*; D014917:Whooping Cough / Q000175:diagnosis / Q000517:prevention & control*
chemical_list: D010567:Pertussis Vaccine; D022282:Vaccines, Acellular; D006632:Histamine; D037342:Pertussis Toxin
keywords: Pertussis vaccines; histamine sensitisation test; replacement alternative