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 |
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| Institution: | 1. Division for Pre-Clinical Innovation, National Center for Advancing Translational Sciences, National Institutes of Health, Bethesda, MD, USA;2. Division of Toxicology, Office of Applied Research and Safety Assessment, Center for Food Safety and Applied Nutrition, U.S. Food and Drug Administration, Laurel, MD, USA;3. National Center for Computational Toxicology, Office of Research and Development, United States Environmental Protection Agency, Research Triangle Park, NC, USA;1. Division of Genetic and Molecular Toxicology, Division of Biochemical Toxicology, National Center for Toxicological Research, U.S Food and Drug Administration, Jefferson, AR 72079, United States;2. Division of Biochemical Toxicology, National Center for Toxicological Research, U.S Food and Drug Administration, Jefferson, AR 72079, United States;3. Division of Nonclinical Science, Center for Tobacco Products, U.S Food and Drug Administration, Silver Spring, MD 20993, United States;4. Division of Clinical Review, Office of Bioequivalence, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S Food and Drug Administration, Silver Spring, MD 20993, United States;1. LabMol – Laboratory for Molecular Modeling and Drug Design, Faculty of Pharmacy, Universidade Federal de Goiás, Goiás 74605-170, Brazil;2. InsilicAll Inc., São Paulo 04363-090, Brazil;3. Laboratory for Molecular Modeling, UNC Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, NC 27599, United States of America;4. Centro Universitário de Anápolis, UniEVANGÉLICA, Goiás 75083-515, Brazil;5. National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods, NIEHS, Durham, NC 27560, United States of America;6. Department of Pharmaceutical Sciences, Federal University of Paraiba, Paraíba 58059-900, Brazil |
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| Abstract: | Regulatory authorities require safety and potency testing prior to the release of each production lot of acellular pertussis (aP)-containing vaccines. Currently, the murine histamine sensitization test (HIST) is used to evaluate the presence of residual pertussis toxin in aP containing vaccines. However, the testing requires the use of a significant number of mice and results in unrelieved pain and distress. NICEATM, ICCVAM, their partners in the International Cooperation on Alternative Test Methods, and the International Working Group for Alternatives to HIST organized a workshop to discuss recent developments in alternative assays to the HIST, review data from an international collaborative study on non-animal alternative tests that might replace the HIST, and address the path toward global acceptance of this type of method. Currently, there are three potential alternative methods to HIST. Participants agreed that no single in vitro method was sufficiently developed for harmonized validation studies at this time. It is unlikely that any single in vitro method would be applicable to all aP vaccines without modification, due to differences between vaccines. Workshop participants recommended further optimization of cell-based assays under development. Participants agreed that the next international collaborative studies should commence in 2013 based on discussions during this workshop. |
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| Keywords: | Pertussis toxin Acellular pertussis vaccines Alternative methods Safety Biochemical assays Cell-based assays |
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