The 'International Workshop on Alternatives to the Murine Histamine Sensitization Test for Acellular Pertussis Vaccines: Progress and Challenges in the Replacement of HIST' was held on 24 August 2014, in Prague, Czech Republic, as a satellite meeting to the 9th World Congress on Alternatives and Animal Use in the Life Sciences. Participants discussed the progress and challenges associated with the development, validation, and implementation of in vitro assays as replacements for the histamine sensitisation test (HIST) for acellular pertussis vaccines. Discussions focused on the consistency approach, the necessary framework for regulatory acceptance of a harmonised method, and recent international efforts towards the development of in vitro assays to replace the HIST. Workshop participants agreed that acceptable alternatives to the HIST should be based on ADP ribosylation-mediated cell intoxication and therefore that the CHO cell clustering assay, which measures cell intoxication, should be further pursued and developed as a possible replacement for the HIST. Participants also agreed to continue ongoing multinational discussions involving national and international standardisation authorities to reach consensus and to organise collaborative studies in this context for assay characterisation and calibration of reference materials.

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GSK

Health Canada

ILS

IntraVacc

NC3Rs

NIEHS

Sanofi Pasteur

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US FDA

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Faulkner A, Skoff T, Martin S, et al. Pertussis. In: Roush SW, Baldy LM, editors. Manual for the Surveillance of Vaccine-Preventable Diseases. Centers for Disease Control and Prevention; Atlanta, USA: 2008. pp. 1–12. Chapter 10.

Mooi FR, van Loo IH, King AJ. Adaptation of Bordetella pertussis to vaccination: a cause for its reemergence? Emerg Infect Dis. 2001;7(Suppl 3):526–28. PubMed PMC

Witt MA, Arias L, Katz PH, et al. Reduced risk of pertussis among persons ever vaccinated with whole cell pertussis vaccine compared to recipients of acellular pertussis vaccines in a large US cohort. Clin Infect Dis. 2013;56(9):1248–54. PubMed

Pertussis vaccines: WHO position paper. Wkly Epidemiol Rec. 2010;85(40):385–400. PubMed

Meade BD, Plotkin SA, Locht C. Possible options for new pertussis vaccines. J Infect Dis. 2014;209(Suppl 1):S24–S27. PubMed

Warfel JM, Zimmerman LI, Merkel TJ. Acellular pertussis vaccines protect against disease but fail to prevent infection and transmission in a nonhuman primate model. Proc Natl Acad Sci USA. 2014;111(2):787–92. PubMed PMC

Isbrucker R, Levis R, Casey W, et al. Alternative methods and strategies to reduce, refine, and replace animal use for human vaccine post-licensing safety testing: state of the science and future directions. Procedia Vaccinol. 2011;5:47–59. PubMed PMC

Bache C, Hoonakker M, Hendriksen C, et al. Workshop on Animal free Detection of Pertussis Toxin in Vaccines – Alternatives to the Histamine Sensitisation Test. Biologicals. 2012;40(4):309–11. PubMed

Isbrucker R. Alternative safety testing strategies for acellular pertussis vaccines. ALTEX Proceedings. 2012;1/12:77–80.

Isbrucker R, Arciniega J, McFarland R, et al. 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. 2014;42(2):114–22. PubMed

Parfentjev IA, Goodline A. Histamine shock in mice sensitized with Hemophilus pertussis vaccine. J Pharmacol Exper Therap. 1948;92(4):411–13. PubMed

Ambrus JL, Packman EW, Rossi GV, et al. The antagonism and synergism of histamine and antihistamines in mice. J Pharm Pharmacol. 1952;4:466–70. PubMed

Pittman M. Determination of the histamine sensitizing unitage of pertussis vaccine. J Biol Standard. 1975;3(2):185–91. PubMed

Kind LS. The altered reactivity of mice after inoculation with Bordetella pertussis vaccine. Bacteriol Rev. 1958;22(3):173–82. PubMed PMC

Diehl SA, McElvany B, Noubade R, et al. C.G proteins Gαi1/3 are critical targets for Bordetella pertussis toxin-induced vasoactive amine sensitization. Infect Immun. 2014;82(2):773–82. PubMed PMC

Mangmool S, Kurose H. G(i/o) protein-dependent and -independent actions of Pertussis Toxin (PTX) Toxins. 2011;3(7):884–99. PubMed PMC

Arciniega JL, Corvette L, Hsu H, et al. Target alternative vaccine safety testing strategies for pertussis toxin. Procedia Vaccinol. 2011;5:248–60.

Carbonetti NH. Pertussis toxin and adenylate cyclase toxin: key virulence factors of Bordetella pertussis and cell biology tools. Future Microbiol. 2010;5(3):455–69. PubMed PMC

Recommendations for whole-cell pertussis vaccine. WHO Expert Committee on Biological Standardization; 2007. Technical Report Series 941, Annex 6.

Bergman RK, Munoz J. Adrenal medullary hormones and sensitization of mice to histamine by the histamine sensitization-factor of Bordetella pertussis. Nature. 1965;205(4975):910–11.

Bergman RK, Munoz J. Circulatory collapse in anaphylaxis and histamine toxicity in mice. J Immunol. 1965;95(1):1–8. PubMed

Ma RZ, Gao J, Meeker ND, et al. Identification of Bphs, an autoimmune disease locus, as histamine receptor H1. Science. 2002;297(5581):620–23. PubMed

Vaessen SF, Bruysters MW, Vandebriel RJ, et al. Toward a mechanism-based in vitro safety test for pertussis toxin. Hum Vaccin Immunother. 2014;10(5581):1391–95. PubMed PMC

Kind LS. Antagonism of cortisone to body temperature reducing effect of histamine. Proc Soc Exp Biol Med. 1954;85(2):371–72. PubMed

Ishida S, Kurokawa M, Asakawa S, et al. A sensitive assay method for the histamine-sensitizing factor using change in rectal temperature of mice after histamine challenge as a response. J Biol Stand. 1979;7(1):21–29. PubMed

Ochiai M, Yamamoto A, Kataoka M, et al. Highly sensitive histamine-sensitization test for residual activity of pertussis toxin in acellular pertussis vaccine. Biologicals. 2007;35(4):259–64. PubMed

Makabe-Kobayasi Y, Hori Y, Adachi T, et al. The control effect of histamine on body temperature and respiratory function in IgE-dependent systemic anaphylaxis. J Allergy Clin Immunol. 2002;110(2):298–303. PubMed

Xing D, Maes A, Behr-Gross ME, et al. Collaborative study for the standardisation of the histamine sensitizing test in mice and the CHO cell-based assay for the residual toxicity testing of acellular pertussis vaccines. Pharmeur Bio Sci Notes. 2010;1:51–63. PubMed

Plotkin SA. Correlates of protection induced by vaccination. Clin Vaccine Immunol. 2010;17(7):1055–65. PubMed PMC

Burns DL, Kenimer JG, Manclark CR. Role of the A subunit of pertussis toxin in alteration of Chinese hamster ovary cell morphology. Infect Immun. 1987;55(1):24–28. PubMed PMC

Brennan MJ, David JL, Kenimer JG, et al. Lectin-like binding of pertussis toxin to a 165-kilodalton Chinese hamster ovary cell glycoprotein. J Biol Chem. 1988;263(10):4895–99. PubMed

Kataoka M, Toyoizumi H, Yamamoto A, et al. Chinese hamster ovary (CHO) cell clustering does not correlate with in vivo histamine-sensitization when measuring residual activity of aldehyde-treated pertussis toxin (PT) Biologicals. 2002;30(4):297–302. PubMed

Yuen CT, Horiuchi Y, Asokanathan C, et al. An in vitro assay system as a potential replacement for the histamine sensitisation test for acellular pertussis based combination vaccines. Vaccine. 2010;28(21):3714–21. PubMed

Oh H, Kim BG, Nam KT, et al. Characterization of the carbohydrate binding and ADP-ribosyltransferase activities of chemically detoxified pertussis toxins. Vaccine. 2013;31(29):2988–93. PubMed

Xing D, Das RG, Newland P, et al. Comparison of the bioactivity of reference preparations for assaying Bordetella pertussis toxin activity in vaccines by the histamine sensitisation and Chinese hamster ovary-cell tests: assessment of validity of expression of activity in terms of protein concentration. Vaccine. 2002;20(29-30):3535–42. PubMed

Less reactogenic whole-cell pertussis vaccine confers protection from Bordetella pertussis infection