NICEATM Announces International Workshop on Alternatives to the Murine Histamine Sensitization Test (HIST)
The National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) announces an "International Workshop on Alternatives to the Murine Histamine Sensitization Test (HIST) for Acellular Pertussis Vaccines: State of the Science and the Path Forward" on November 28-29, 2012. The workshop will be held at the William H. Natcher Conference Center at NIH headquarters in Bethesda, Maryland. NICEATM is organizing the workshop in collaboration with the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) and partner organizations in the InternationalCooperation on Alternative Test Methods.
The upcoming workshop will provide a forum to discuss and review protocols and available data from an ongoing study of in vitro alternatives to the HIST test. The workshop will review new innovative methods and approaches for acellular pertussis vaccine safety testing that may provide greater accuracy, precision, and efficiency and that are more humane and use fewer or no animals. Finally, the workshop will address the path to achieve validation, global acceptance, and implementation of new alternative methods for acellular pertussis vaccine testing.
Pertussis, also known as whooping cough, is a highly contagious bacterial disease that was a major cause of childhood mortality until vaccines became available. Regulatory authorities require safety, potency, and purity testing prior to release of pertussis or pertussis-containing vaccines. The murine histamine sensitization test (HIST) is a key safety test performed to ensure that pertussis toxin in these vaccines has been effectively inactivated. However, such testing may involve large numbers of mice, some of which can experience significant unrelieved pain and distress. An international workshop organized in 2010 by NICEATM, ICCVAM, and their international partners identified the HIST as a high priority for future research, development, and validation of alternative test methods that could further reduce, refine, or replace animal use for acellular pertussis vaccine safety testing.