Overview of currently approved veterinary vaccine potency testing methods and methods in development that do not require animal use

Draayer, Hans

doi:10.1016/j.provac.2011.10.016

Cited by 10 publications

(8 citation statements)

References 3 publications

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“…The second plenary session addressed methods that have been accepted and methods that are in development that do not require the use of animals for assessing the potency of vaccines [17,18,19,20]. This was followed by breakout sessions to discuss the state of the science and recommendations for future progress for in vitro potency tests for human and veterinary vaccines.…”

Section: Goals and Organization Of The Workhopmentioning

confidence: 99%

Non-animal replacement methods for human vaccine potency testing: state of the science and future directions

McFarland¹,

Verthelyi²,

Casey³

et al. 2011

Procedia in Vaccinology

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NICEATM and ICCVAM convened an international workshop to review the state of the science of human and veterinary vaccine potency and safety testing methods, and to identify opportunities to advance new and improved methods that can further reduce, refine, and replace animal use. This report addresses methods and strategies identified by workshop participants for replacement of animals used for potency testing of human vaccines. Vaccines considered to have the highest priority for future efforts were (1) vaccines for which antigen quantification methods are already developed but not validated, (2) vaccines/components that require the largest number of animals, (3) vaccines that require an in vivo challenge test, and (4) vaccines with in vivo tests that are highly variable and cause a significant number of invalid tests. Vaccine potency tests identified as the highest priorities for replacement were those for diphtheria and tetanus, pertussis (whole cell and acellular), rabies, anthrax, polio vaccine (inactivated) and complex combination vaccines based on DT or DTwP/aP. Research into understanding the precise mechanism of protection afforded by vaccines and the identification of clinically relevant immunological markers are needed to facilitate the successful implementation of in vitro testing alternatives. This report also identifies several priority human vaccines and associated research objectives that are necessary to successfully implement in vitro vaccine potency testing alternatives.

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Section: Goals and Organization Of The Workhopmentioning

confidence: 99%

Non-animal replacement methods for human vaccine potency testing: state of the science and future directions

McFarland¹,

Verthelyi²,

Casey³

et al. 2011

Procedia in Vaccinology

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“…Titration of live organisms (in vitro but occasionally in vivo) In vitro assays such as ELISAs or other quantitative methods Serology methods (in vivo to in vitro) Vaccination-challenge in vivo methods using either the host animal (fish, poultry) or laboratory animals (e.g., hamsters, mice) [17] For a typical U.S. veterinary vaccine manufacturer, 37% of tests use in vitro titration assays, 22% use in vitro ELISAs, 12% use some other in vitro method, 8% use in vivo serology test, and 21% use in vivo vaccinationchallenge methods [17]. These data exclude poultry and fish vaccine potency testing but do suggest that in vitro methods are being applied for most potency testing conducted on veterinary vaccines.…”

Section: State Of the Sciencementioning

confidence: 99%

“…These data exclude poultry and fish vaccine potency testing but do suggest that in vitro methods are being applied for most potency testing conducted on veterinary vaccines. Animal welfare concerns, increased scientific accuracy, and the financial benefits associated with in vitro assays provide significant incentives to veterinary vaccine manufacturers for the replacement of animals for potency testing procedures, especially if a vaccine product can be released without the potential concern for repeat in vivo testing [17,60].…”

Section: State Of the Sciencementioning

confidence: 99%

“…Understanding the protective antigen was identified as the primary technical issue. However, for many veterinary vaccines, especially bacterial vaccine products, the protective antigen is unknown or is a complex combination of antigens [17]. Therefore, development of antigen quantification tests is technically difficult because demonstrating a dose response between an antigen and protection in the target species may not be possible.…”

Section: Knowledge Gaps and Priority Research Development And Validmentioning

confidence: 99%

“…The USDA recently developed a sandwich ELISA as an alternative in vitro test using rabbit polyclonal capture and a specific mouse monoclonal detecting antibody to measure the relative potency of specific bacterins compared to a qualified reference standard for several Leptospira interrogans serovars including pomona [81], canicola [37], grippotyphosa [82], and icterohaemorrhagiae [83]. Studies still to be completed include the testing of adjuvants and other vaccine components on assay interference [17]. The in vivo and in vitro assay methods are currently published by the USDA in SAMs and European monographs (e.g., canine leptospiral antigen quantification method, Ph.…”

Section: Leptospira Spp Vaccinesmentioning

confidence: 99%

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Non-animal replacement methods for veterinary vaccine potency testing: state of the science and future directions

Kulpa-Eddy

Srinivas

Halder

et al. 2011

Procedia in Vaccinology

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NICEATM and ICCVAM convened an international workshop to review the state of the science of human and veterinary vaccine potency and safety testing methods and to identify opportunities to advance new and improved methods that can further reduce, refine, and replace animal use. Six topics were addressed in detail by speakers and workshop participants and are reported in a series of six reports. This workshop report, the second in the series, provides recommendations for current and future use of nonanimal methods and strategies for veterinary vaccine potency testing. Workshop participants recommended that future efforts to replace animal use give priority to vaccines (1) that use large numbers of animals per test and for which many serials are produced annually, (2) that involve significant animal pain and distress during procedures, (3) for which the functional protective antigen has been identified, (4) that involve foreign animal/zoonotic organisms that are dangerous to humans, and (5) that involve pathogens that can be easily spread to wildlife populations. Vaccines identified as the highest priorities were those for rabies, Leptospira spp., Clostridium spp., Erysipelas, foreign animal diseases (FAD), poultry diseases, and fish diseases. Further research on the identification, purification, and characterization of vaccine protective antigens in veterinary vaccines was also identified as a priority. critical knowledge and data gaps, including opportunities to apply new science and technology. Recommendations included (1) investigations into the relative impact of various adjuvants on antigen quantification assays, (2) investigations into extraction methods that could be used for vaccines containing adjuvants that can interfere with antigen assays, and (3) review of the current status of rabies and tetanus human vaccine in vitro potency methods for their potential application to the corresponding veterinary vaccines. Workshop participants recommended enhanced international harmonization and cooperation and closer collaborations between human and veterinary researchers to expedite progress. Implementation of the workshop recommendations is expected to advance alternative in vitro methods for veterinary vaccine potency testing that will benefit animal welfare and replace animal use while ensuring continued protection of human and animal health.

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The Potential Use of Animals for the Production of Veterinary Products

Bashir,

Muhammad,

Shah

et al. 2024

Recent Advances in Industrial Biochemistry

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Overview of currently approved veterinary vaccine potency testing methods and methods in development that do not require animal use

Cited by 10 publications

References 3 publications

Non-animal replacement methods for human vaccine potency testing: state of the science and future directions

Non-animal replacement methods for human vaccine potency testing: state of the science and future directions

Non-animal replacement methods for veterinary vaccine potency testing: state of the science and future directions

The Potential Use of Animals for the Production of Veterinary Products

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