Workshops on Alternatives to the HIST for Acellular Pertussis Vaccines

Pertussis, also known as whooping cough, was once a major cause of childhood mortality in the United States, but widespread vaccination has decreased its incidence substantially.

The murine histamine sensitization test (HIST) is 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.

NICEATM and international collaborators conducted workshops in 2012, 2014, and 2015 to discuss and review an international study of a non-animal alternative to the HIST. The 2015 workshop produced a stepwise adoption plan to implement the alternative method to reduce animal use for pertussis vaccine safety testing.

Workshop - In Search of Acceptable Alternatives to the Murine Histamine Sensitization Test (HIST): What Is Possible and Practical?

March 4-5, 2015 — London, England

Workshop Report: Wagner L et al. 2016. In search of acceptable alternatives to the murine histamine sensitisation test (HIST): what is possible and practical? Pharmeur Bio Sci Notes 2016:151-170.

Participants in this workshop discussed the results of the data generated from an international collaborative study sponsored by the European Directorate for the Quality of Medicines and HealthCare (EDQM). Participants agreed that the in vitro assay used in the study could measure pertussis toxin in reference preparations. They also agreed that using this assay in acellular pertussis vaccine batch release testing would reduce the number of animals required for this testing. A strategic, stepwise adoption plan was proposed, in which the alternative test would be used for release purposes first, and then, once sufficient confidence in its suitable performance has been gained, its use would be extended to stability testing.

Workshop on Alternatives to the HIST for Acellular Pertussis Vaccines: Progress and Challenges in the Replacement of HIST

A Satellite Meeting of the Ninth World Congress on Alternatives and Animal Use in the Life Sciences

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.

This workshop was 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 EDQM. It 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 development of such alternative assays. Discussion at the August 2014 workshop laid the groundwork for the March 2015 meeting.

International Workshop on Alternatives to the Murine Histamine Sensitization Test (HIST) for Acellular Pertussis Vaccines: State of the Science and the Path Forward

November 28-29, 2012 — Bethesda, MD, USA

Workshop Report: Isbrucker et al. 2014. Report on the international workshop on alternatives to the murine histamine sensitization test (HIST) for acellular pertussis vaccines: State of the science and the path forward. Biologicals 42(2):114-122.

This workshop was organized by NICEATM, ICCVAM, their partners in the International Cooperation on Alternative Test Methods, and the International Working Group for Alternatives to the HIST. Participants discussed recent developments in alternative assays to the HIST, reviewed data from an international collaborative study on three non-animal alternative tests that might replace the HIST, and addressed the path toward global acceptance of this type of method. While they agreed that no single in vitro method was sufficiently developed for harmonized validation studies at this time, participants recommended further optimization of cell-based assays under development.