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International Workshop on Alternatives to the Murine Histamine Sensitization Test (HIST) for Acellular Pertussis Vaccines

Event details
Aug 24, 2014
from 09:30 AM to 04:30 PM
Prague (CZ)
Organizer: NICEATM, NC3Rs, ICCVAM, EURL ECVAM, Health Canada, EDQM

In vitro alternatives to the use of mice for the quality control of acellular pertussis vaccines

The 'International Workshop on Alternatives to the Murine Histamine Sensitization Test (HIST) for Acellular Pertussis Vaccines: Progress and Challenges in the Replacement of HIST' will take place next August in Prague, as a Satellite Meeting to the '9th World Congress on Alternatives and Animal Use in the Life Sciences (WC9)'. The event is organised by the 'International Working Group on Alternatives to the HIST' (a consortium of stakeholders representing government, industry, and research institutions). EURL ECVAM (the EU Reference Laboratory for Alternatives to Animal Testing) is a member of the organising committee.

The following will be discussed:

  • implementation of in vitro assays as replacements for the HIST for acellular pertussis vaccines on the basis of the consistency approach;
  • necessary framework for regulatory acceptance of a harmonized approach that uses in vitro assays instead of the HIST;
  • recent international efforts towards the development of in vitro assays to replace the HIST.

More information and agenda on the WC9 web site

Registration (deadline: August 21, 2014, at 11:59 PM Eastern Daylight Time (EDT))

Background information

Pertussis, also known as whooping cough, is a highly contagious bacterial disease. Pertussis was once a major cause of childhood mortality, but widespread vaccination has decreased its incidence substantially.

Regulatory authorities require testing prior to the release of each production lot of pertussis or pertussis antigen-containing vaccines. The murine histamine sensitization test (HIST) is a key safety test performed to ensure that pertussis toxin in acellular pertussis vaccines has been effectively inactivated. However, such testing uses many mice, some of which can experience significant unrelieved pain and distress. In addition, the HIST has technical challenges requiring frequent retesting, increasing vaccine testing expense and animal use.

Image: Logo of WC9 (Courtesy WC9 web site).