In Search of Acceptable Alternatives to the Murine Histamine Sensitization Test: What is Possible and Practical?
The NC3Rs is hosting a workshop to bring together scientists from government, industry, academia, and research institutions to discuss and evaluate alternative methods to the murine histamine sensitization test (HIST) for monitoring of residual pertussis toxin activity in acellular pertussis vaccines.
The workshop is organized by the ‘International Working Group on Alternatives to the HIST’, a consortium of interested stakeholders representing government, industry, and research institutions. The key objectives of the workshop will be to:
Review and discuss data generated from an international collaborative study sponsored by the European Directorate for the Quality of Medicines and Health Care (EDQM) to determine if a cell-based assay is a suitable alternative for replacement of HIST.
Review recent scientific advances that can be applied to acellular pertussis vaccine testing to provide greater accuracy and precision of results, improve testing efficiency and to reduce or ultimately replace the use of animals in this area.
Discuss issues associated with assay design and validation, effect of product toxoiding and adjuvanting on testing outcome, and preparation and calibration of reference standards for alternative methods.