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 in Vaccinology

Volumn 5, Issue , 2011, Pages 47-59

  Isbrucker, Richard ^a   Levis, Robin ^b   Casey, Warren ^c   McFarland, Richard ^b   Schmitt, Michael ^b   Arciniega, Juan ^b   Descamps, Johan ^d   Finn, Theresa ^b   Hendriksen, Coenraad ^e   Horiuchi, Yoshinobu ^f   Keller, James ^b   Kojima, Hajime ^g   Sesardic, Dorothea ^h   Stickings, Paul ^h   Johnson, Nelson W ⁱ   Allen, David ⁱ  

^a HEALTH CANADA   (Canada)

^b CENTER FOR BIOLOGICS EVALUATION AND RESEARCH   (United States)

^c NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES   (United States)

^d GLAXOSMITHKLINE BIOLOGICALS   (Belgium)

^e NETHERLANDS VACCINE INSTITUTE   (Netherlands)

^f PHARMACEUTICALS AND MEDICAL DEVICES AGENCY   (Japan)

^g Japanese Center for the Validation of Alternative Methods   (Japan)

^h NATIONAL INSTITUTE FOR BIOLOGICAL STANDARDS AND CONTROL   (United Kingdom)

ⁱ INTEGRATED LABORATORY SYSTEMS   (United States)

Author keywords

3Rs alternatives; Human vaccines; ICCVAM; Vaccine potency testing; Vaccine safety testing

Indexed keywords

BACTERIUM LIPOPOLYSACCHARIDE; ENDOTOXIN; VACCINE;

ANIMAL TESTING REDUCTION; ANIMAL TESTING REFINEMENT; ANIMAL TESTING REPLACEMENT; ARTICLE; BODY TEMPERATURE; CELL ASSAY; CHO CELL; DRUG INTERACTION; DRUG SAFETY; DRUG SCREENING; LEUKOCYTE PROMOTION TEST; LICENSING; LIMULUS LYSATE TEST; MOUSE WEIGHT GAIN TEST; NONHUMAN; PRIORITY JOURNAL; TOXICITY TESTING; TOXICOKINETICS; VIRUS VIRULENCE; WORKSHOP;

EID: 84555191840     PISSN: None     EISSN: 1877282X     Source Type: Journal    
DOI: 10.1016/j.provac.2011.10.004     Document Type: Article

References (68)

1. Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM). The NICEATM-ICCVAM five-year plan (2008-2012): a plan to advance alternative test methods of high scientific quality to protect and advance the health of people, animals, and the environment. National Institute of Environmental Health Sciences, 2008. NIH Publication No. 08-6410. http://iccvam.niehs.nih.gov/docs/5yearplan.htm.
2. Stokes WS, Kulpa-Eddy J, McFarland RM. Introduction and summary of the international workshop on alternative methods to reduce, refine, and replace the use of animals in vaccine potency and safety testing: state of the science and future directions. Proc Vaccinol 2011 (current issue).
3. McFarland R, Verthelyi D, Casey W, Arciniega J, Isbrucker R, Schmitt M, Finn T, Descamps J, Horiuchi Y, Sesardic D, Stickings P, Johnson NW, Lipscomb E, Allen D. Non-animal replacement methods for human vaccine potency testing: state-of-the-science and future directions. Proc Vaccinol 2011 (current issue).
4. Kulpa-Eddy J, Srinivas G, Halder M, Hill R, Brown K, Roth J, Draayer H, Galvin J, Claassen I, Gifford G, WoodlandR, Doelling V, Jones B, Stokes WS. Non-animal replacement methods for veterinary vaccine potency testing: state-of-the-science and future directions. Proc Vaccinol 2011 (current issue).
5. Casey W, Schmitt M, McFarland R, Isbrucker R, Levis R, Arciniega J, Descamps J, Finn T, Hendriksen C, Horiuchi Y, Keller J, Kojima H, Sesardic D, Stickings P, Johnson NW, Lipscomb E, Allen D. Improving animal welfare and reducing and refining animal use for human vaccine potency testing: state-of-the-science and future directions. Proc Vaccinol 2011 (current issue).
6. Stokes WS, Brown K, Kulpa-Eddy J, Srinivas G, Halder M, Draayer H, Galvin J, Claassen I, Gifford G, Woodland R, Doelling V, Jones B. Improving animal welfare and reducing animal use for veterinary vaccine potency testing: state-of-the-science and future directions. Proc Vaccinol 2011 (current issue).
7. Isbrucker R, Levis R, Casey W, McFarland R, Schmitt M, Arciniega J, Descamps J, Finn T, Hendriksen C, Horiuchi Y, Keller J, Kojima H, Sesardic D, Stickings P, Johnson NW, Allen D. 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. Proc Vaccinol 2011 (current issue).
8. Kulpa-Eddy J, Srinivas G, Halder M, Hill R, Brown K, Draayer H, Galvin J, Claassen I, Gifford G, Woodland R, Doelling V, Jones B, Stokes WS. Alternative methods and strategies to reduce, refine, and replace animal use for veterinary vaccine post-licensing safety testing: state of the science and future directions. Proc Vaccinol 2011 (current issue).
9. Roth J. Veterinary vaccines and their importance to animal health and public health. Proc Vaccinol 2011 (current issue).
10. Schuchat A. Human vaccines and their importance to public health. Proc Vaccinol 2011 (current issue).
11. Finn T. U.S. FDA Requirements for human vaccine safety and potency testing. Proc Vaccinol 2011 (current issue).
12. Hill RE. USDA requirements for veterinary vaccine safety and potency testing. Proc Vaccinol 2011 (current issue).
13. Isbrucker R, Sontakke S, Smith D. Health Canada's human vaccine lot release program: impact on the 3Rs. Proc Vaccinol 2011 (current issue).
14. Woodland R. European regulatory requirements for veterinary vaccine safety and potency testing and recent progress toward reducing animal use. Proc Vaccinol 2011 (current issue).
15. Horiuchi Y, Ochiai M, Kataoka M, Yamamoto A, Yuen C-T, Asokanathan C, Corbel M, Kurata T, Xing D. Strategic approaches for developing alternative tests for safety and potency of vaccines. Proc Vaccinol 2011 (current issue).
16. Shin J, Lei D, Conrad C, Knezevic I, Wood D. International Regulatory Requirements for Vaccine Safety and Potency Testing: A WHO perspective. Proc Vaccinol 2011 (current issue).
17. Draayer H. Overview of currently approved veterinary vaccine potency testing methods and methods in development that do not require animal use. Proc Vaccinol 2011 (current issue).
18. Claassen I. Case study of development, validation, and acceptance of a non-animal method for assessing veterinary vaccine potency. Proc Vaccinol 2011 (current issue).
19. Levis R. Overview of the current status of human vaccine potency testing methods that replace animals. Presented at: International Workshop on Alternative Methods to Reduce, Refine, and Replace the Use of Animals in Vaccine Potency and Safety Testing: State of the Science and Future Directions. NICEAM. Bethesda, MD. September 2010. Available at: http://iccvam.niehs.nih.gov/meetings/BiologicsWksp-2010/BiologicsWksp-present.htm.
20. Descamps J, et al. A Case study of development, validation, and acceptance of a non-animal method for assessing human vaccine potency. Proc Vaccinol 2011 (current issue).
21. Keller JE. Overview of currently approved serological methods with a focus on diphtheria and tetanus toxoid potency testing. Proc Vaccinol 2011 (current issue).
22. Srinivas G. Refinement alternatives for veterinary vaccine potency testing: overview of currently approved serological methods. Presented at: International Workshop on Alternative Methods to Reduce, Refine, and Replace the Use of Animals in Vaccine Potency and Safety Testing: State of the Science and Future Directions. NICEAM. Bethesda, MD. September 2010. Available at: http://iccvam.niehs.nih.gov/meetings/BiologicsWksp-2010/BiologicsWksp-present.htm.
23. Stickings P, Rigsby P, Coombes L, Hockley J, Tierney R, Sesardic D. Animal refinement and reduction: alternative approaches for potency testing of diphtheria and tetanus vaccines. Proc Vaccinol 2011 (current issue).
24. Arciniega JL, Domínguez-Castillo RI. Development and validation of serological methods for human vaccine potency testing: case study of an anthrax vaccine. Proc Vaccinol 2011 (current issue).
25. Hendriksen CFM. Humane endpoints in vaccine potency testing. Proc Vaccinol 2011 (current issue).
26. Kulpa-Eddy J, Srinivas G. Examples of approaches to reducing animal numbers in vaccine potency testing. Proc Vaccinol 2011 (current issue).
27. Kulpa-Eddy J, Dusek D. Application of the consistency approach in the United States to reduce animal use in vaccine potency testing. Proc Vaccinol 2011 (current issue).
28. Gifford G, Agrawal P, Hutchings D, Yarosh O. Veterinary vaccine post-licensing safety testing: overview of current regulatory requirements and accepted alternatives. Proc Vaccinol 2011 (current issue).
29. Arciniega JL, Corvette L, Hsu H, Lynn F, Romani T, Dobbelaer R. Target alternative vaccine safety testing strategies for Pertussis toxin. Proc Vaccinol 2011 (current issue).
30. Rubin SA. Toward replacement of the monkey neurovirulence test in vaccine safety testing. Proc Vaccinol 2011 (current issue).
31. Public Health Service Act. 1944 (as amended). 42 U.S.C. 6A. Available at: http://www.FDA.gov/RegulatoryInformation/Legislation/ucm148717.htm.
32. European Pharmacopoeia. Monograph 443. Diphtheria vaccine absorbed, Ph. Eur. 6th Edition. Strasbourg, France: European Department for the Quality of Medicines within the Council of Europe; 2008.
33. Japanese Minimum Requirements for Biological Products. National Institute of Infectious Diseases, Japan 2006.
34. World Health Organization Expert. Committee on Biological Standardization, Fortieth Report. Requirements for Diphtheria, Tetanus, Pertussis and Combined Vaccines. Technical Report Series No. 800 Annex 2. WHO, Geneva, 1990:87-179.
35. United States Code of Federal Regulations, Title 21 Part 610 General Biological Products Standards Section 610.11. http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?sid=bdffeb20f7459487424b72d073e473e9&c=ecfr&tpl=/ecfrbrowse/Title21/21tab_02.tpl.
36. Schwanig M, Nagel M, Duchow K, Krämer B. Elimination of abnormal toxicity test for sera and certain vaccines in the European Pharmacopoeia. Vaccine. 1997;15(10):1047-1048.
37. European Pharmacopoeia. Monograph 0215. Poliomyelitis vaccine (oral), Ph.Eur. 7th Edition. Strasbourg, France: European Department for the Quality of Medicines within the Council of Europe; 2011.
38. World Health Organization. Committee on Biological Standardization, Fiftieth report. Recommendations for the production and control of poliomyelitis vaccine (oral). Technical Report Series No. 904 Annex 1. WHO, Geneva, 2002.
39. World Health Organization Expert Committee on Biological Standardization, Fortieth Report. Requirements for poliomyelitis vaccine, oral. Technical Report Series No. 800 Annex 1. WHO, Geneva, 1990:30-86.
40. Hoonakker ME, Ruiterkamp N, Hendriksen CFM. The cAMP assay: a functional in vitro alternative to the in vivo histamine sensitization test. Vaccine 2010;28:1347-1352.
41. Gomez SR, Xing D K-L, Corbel MJ, Coote J, Parton R, Yuen C-T. Development of a carbohydrate binding assay for the B-oligomer of pertussis toxin and toxoid. Anal Biochem 2006;356:244-253.
42. World Health Organization Expert Committee on Biological Standardization. Fifty-sixth report. Recommendations for whole cell pertussis vaccine. Technical Report Series No. 941 Annex 6. WHO, Geneva, 2007:301-334.
43. Hendriksen C. Replacement, reduction and refinement alternatives to animal use in vaccine potency measurement. Expert Rev. Vaccines 2008;8(3):313-322.
44. European Pharmacopoeia. Monograph 0161. Pertussis vaccine (whole cell, adsorbed), Ph.Eur. 7th Edition. Strasbourg, France: European Department for the Quality of Medicines within the Council of Europe; 2011.
45. European Pharmacopoeia. Monograph 1356. Pertussis Vaccine Acellular Component, Absorbed, Ph.Eur. 6th Edition. Strasbourg, France: European Department for the Quality of Medicines within the Council of Europe; 2008.
46. European Pharmacopoeia. Monograph 1595. Pertussis Vaccine Acellular, Copurified, Absorbed, Ph.Eur. 6th Edition. Strasbourg, France: European Department for the Quality of Medicines within the Council of Europe; 2008.
47. Arciniega JL, Corbel M, Dellepiane N, Dobbelaer R, Griffiths E, Heron I, et al. WHO guidelines for the production and control of the acellular pertussis component of monovalent or combined vaccines. Biologicals 1998; 26(3):195-204.
48. Ochiai M, Yamamoto A, Kataoka M, Toyoizumi H, Arakawa Y, Horiuchi Y. Highly sensitive histamine-sensitization test for residual activity of pertussis toxin in acellular pertussis vaccine. Biologicals. 2007;35:259-264.
49. World Health Organization Expert Committee on Biological Standardization. Forty-seventh report. Guidelines for the production and control of the acellular pertussis component of monovalent or combined vaccines. WHO Technical Report Series No. 878 Annex 2, WHO Geneva, 1998:57-76.
50. European Pharmacopoeia. Monograph 218. Rabies vaccine for human use prepared in cell cultures, Ph. Eur. 6th Edition. Strasbourg, France: European Department for the Quality of Medicines within the Council of Europe; 2008.
51. World Health Organization Expert Committee on Biological Standardization. Forty-seventh report. Requirements for poliomyelitis vaccine. WHO Technical Report Series No. 889, WHO Geneva, 1999.
52. Metz B, Brunel F, Chamberlin C, van der Gun J, Halder M, Jiskoot W, Kersten G, van Opstal O, Petersen JW, Ravetkar SD, Redhead K, Schwanig M, Wilhelmsen ES, Vann WF, Hendriksen C. The potential of physiochemical and immunochemical assays to replace animal tests in the quality control of toxoid vaccines. The report and recommendations of ECVAM Workshop 61. ATLA 2007;35:323-331.
53. World Health Organization Expert Committee on Biological Standardization. Fifty-fourth report. Recommendations for diphtheria, tetanus, pertussis and combined vaccines (Amendments 2003). WHO Technical Report Series No. 927, WHO Geneva, 2005.
54. Van Straaten-van de Kappelle I, van der Gun JW, Marsman FR, Hendriksen CFM, van de Donk HJM. Collaborative study on test systems to assess toxicity of whole cell pertussis vaccine. Biologicals. 1997;25:41-57.
55. Ren R, Costantini F, Gorgacz EJ, Lee JJ, Racaniello VR. Transgenic mice expressing a human poliovirus receptor: a new model for poliomyelitis. Cell. 1990;63:353-362.
56. Koike S, Taya C, Kurata T, Abe S, Ise I, Yonekawa H, Nomoto A. Transgenic mice susceptible to poliovirus. Proc. Natl. Acad. Sci. USA. 1991;88:951-955.
57. Organizers. IABs scientific workshop on neurovirulence test for live virus vaccines, January 31 - February 1, 2005, Geneva. Biologicals. 2006;34:233-236.
58. Evans DMA, Dunn G, Minor PD, Schild GC, Cann AJ, Stanway G, Almond JW, Currey JV, Maizel JV Jr. Increased neurovirulence associated with a single nucleotide change in a noncoding region of the Sabin type 3 poliovaccine genome. Nature. 1985;314:548-550.
59. Neverov A and Chumakov K. Massively parallel sequencing for monitoring genetic consistency and quality control of live viral vaccines. PNAS. 2010;107:20063-20068.
60. European Pharmacopoeia. 2.6.8 Pyrogens, Ph. Eur. 7th Edition. Strasbourg, France: European Department for the Quality of Medicines within the Council of Europe; 2011:161-162.
61. Pearson CF. LAL. Testing and depyrogenation. In: Robinson JR, Editor. Pyrogens. New York: Marcel Dekker, 1985;3-272.
62. Metz B, Hendriksen C, Jiskoot W, Kersten GFA. Reduction of animal use in human vaccine quality control: opportunities and problems. Vaccine. 2002;20:2411-2430.
63. Tsai CM, Frasch CE, Rivera E, Hochstein HD. Measurements of lipopolysaccharide (endotoxin) in meningococcal protein and polysaccharide preparations for vaccine usage. J Biol Stand. 1989;17:249-258.
64. Park CY, Jung SH, Bak JP, Lee SS, Rhee DK. Comparison of the rabbit pyrogen test and Limulus amoebocyte lysate (LAL) assay for endotoxin in hepatitis B vaccines and the effect of aluminum hydroxide. Biologicals. 2005;33:145-151.
65. Hoffmann S, Peterbauer A, Schindler S, Fennrich S, Poole S, Mistry Y, Montag-Lessing T, Spreitzer I, Löschner B, van Aalderen M, Bos R, Gommer M, Nibbeling R, Werner-Felmayer G, Loitzl P, Jungi T, Brcic M, Brügger P, Frey E, Bowe G, Casado J, Coecke S, de Lange J, Mogster B, Næss LM, Aaberge IS, Wendel A, Hartung T. International validation of novel pyrogen tests based on human moncytoid cells. J Immunol Methods. 2005;298:161-173.
66. ICCVAM. ICCVAM test method evaluation report: validation status of five in vitro test methods proposed for assessing potential pyrogenicity of pharmaceuticals and other products. HIH Publication No: 08-6392. Research Triangle Park:National Toxicology Program, 2008b. Available at: http://iccvam.niehs.nih.gov/methods/pyrogen/pyr_tmer.htm.
67. European Pharmacopoeia. 2.6.14 Bacterial endotoxins, Ph. Eur. 7th Edition. Strasbourg, France: European Department for the Quality of Medicines within the Council of Europe; 2011:171-175.
68. Hendriksen CFM. Towards eliminating the use of animals for regulatory required vaccine quality control. ALTEX 2006;23:187-190.