Sunday, August 24, 2014
Prague, Czech Republic
Workshop Report: Arciniega J et al. 2016. Alternatives to HIST for acellular pertussis vaccines: progress and challenges in replacement. Report on an international workshop. Pharmeur Bio Sci Notes 2015:82-96.
"Workshop - In Search of Acceptable Alternatives to the Murine Histamine Sensitization Test (HIST): What Is Possible and Practical?"
March 4-5, 2015 — London, England
Read workshop report in Pharmeuropa Bio and Scientific Notes (search on term "histamine" to find document)
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.
This workshop organized by the International Working Group for Alternatives to the HIST, a consortium of interested stakeholders representing government, industry, animal welfare organizations, research and regulatory institutions, and the European Directorate for the Quality of Medicines and HealthCare brought together scientists involved in this collaboration to review and discuss the implementation of in vitro assays as alternatives to the HIST for the testing of acellular pertussis vaccines. The workshop also provided a forum for reviewing the current framework for regulatory acceptance of a harmonized approach for alternative in vitro assays to HIST in the context of recent international progress in the development of such alternative assays. Discussion at the August 2014 workshop laid the groundwork for a meeting held in March 2015.