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Summary of HIST Workshop Now Available from ICCVAM

A summary is now available of the November 2012 "International Workshop on Alternatives to the Murine Histamine Sensitization Test (HIST) for Acellular Pertussis Vaccines." This workshop brought together over 40 scientific experts from 10 different countries representing government, industry, and academia to review and discuss the usefulness and limitations of in vitro alternatives to the HIST.

Participants reviewed and discussed data generated in a 12-laboratory international study to evaluate the performance of in vitro assays using both a single pertussis toxin (PTx) standard and common sets of seven vaccines from three manufacturers.  Participants agreed that the current mouse HIST should be replaced with a suitable in vitro alternative test(s) and that any proposed replacement method(s) must ensure that the vaccine contains safe levels of PTx. Advantages and disadvantages of the alternatives were recognized. Participants recommended further development and optimization of specific methods and to move forward with an international collaborative study for calibration of the pertussis toxin standard using a standardized CHO cell assay in 2013.

The workshop was held at the headquarters of the U.S. National Institutes of Health in Bethesda, Maryland. The National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) organized the workshop in collaboration with the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) and partner organizations in the International Cooperation on Alternative Test Methods.

The workshop summary is available on the ICCVAM website. The final workshop program and a link to slides presented at the workshop are also available on this page. A report of the workshop will be published in 2013 in the journal Biologicals.

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