Three Rs Approaches in the Quality Control of Inactivated Rabies Vaccines: The Report and Recommendations of ECVAM Workshop 48<sup>,</sup>

Bruckner, L; Cußler, Klaus; Halder, Marlies; Barrat, J; Castle, Peter; Duchow, Karin; Gatewood, Donna M.; Gibert, R; Groen, Jan; Knapp, Bernhard; Levis, Robin; Milne, C; Parker, Simon; Stünkel, Karin; Nico, Visser; Volkers, Peter

doi:10.1177/026119290303100409

Cited by 35 publications

(43 citation statements)

References 15 publications

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“…Approximately half of the test animals die or develop acute signs of rabies (e.g., convulsions, paresis, paralysis). The inherent variability of this assay contributes to a high number of invalid assays, which leads to further use of animals for repeat testing [59]. The potential exposure of laboratory technicians to biohazardous materials during testing is also an important consideration.…”

Section: State Of the Sciencementioning

confidence: 99%

“…There are antigen quantification methods available that may one day eliminate the need for an in vivo potency test (replacement), leading to a significant reduction in the use of animals for testing. Several types of in vitro ELISA procedures for rabies vaccines have been developed during the past few years, taking advantage of advances in defining the neutralizing epitopes [59,60,61]. While these assays would confer distinct advantages over in vivo test methods (e.g., no animals required, faster, less costly), limitations that have impeded their development and implementation include the following: (1) they are not universally applicable to all vaccine strains, (2) they cannot be used in combination with adjuvants, and (3) they do not correlate well with the in vivo challenge test [35,59].…”

Section: State Of the Sciencementioning

confidence: 99%

“…Several types of in vitro ELISA procedures for rabies vaccines have been developed during the past few years, taking advantage of advances in defining the neutralizing epitopes [59,60,61]. While these assays would confer distinct advantages over in vivo test methods (e.g., no animals required, faster, less costly), limitations that have impeded their development and implementation include the following: (1) they are not universally applicable to all vaccine strains, (2) they cannot be used in combination with adjuvants, and (3) they do not correlate well with the in vivo challenge test [35,59]. Clear correlations have yet to be demonstrated among the amount of antigen required to induce a protective immune response in animals, the amount of antigen measured using alternative in vitro assays, and the immune response in human vaccines [19].…”

Section: State Of the Sciencementioning

confidence: 99%

See 2 more Smart Citations

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: State Of the Sciencementioning

confidence: 99%

Section: State Of the Sciencementioning

confidence: 99%

Section: State Of the Sciencementioning

confidence: 99%

See 1 more Smart Citation

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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“…Several types of antigen quantification tests are currently in development for inactivated rabies veterinary vaccines, including single radial diffusion tests, antibody-binding tests, and ELISA methods [57,116,117]. Although the ELISA assays are reproducible, inexpensive, and quantitative, they are currently product specific, and reagents are not universally available [116]. In addition, it has yet to be demonstrated that the antigen concentration in the vaccine can be correlated with an ability to stimulate a protective immune response [118].…”

Section: Rabies Vaccinesmentioning

confidence: 99%

“…In addition, it has yet to be demonstrated that the antigen concentration in the vaccine can be correlated with an ability to stimulate a protective immune response [118]. Furthermore, guidance and/or recommendations from global regulatory agencies are necessary to resolve how any new alternative assay (i.e., serological or antigen quantification) can be validated against the current, highly variable in vivo assay [22,116].…”

Section: Rabies Vaccinesmentioning

confidence: 99%

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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Inactivated Viral Vaccines

Sanders

Koldijk

Schuitemaker

2014

Vaccine Analysis: Strategies, Principles, and Control

132

135

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Three Rs Approaches in the Quality Control of Inactivated Rabies Vaccines: The Report and Recommendations of ECVAM Workshop 48^,

Cited by 35 publications

References 15 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

Inactivated Viral Vaccines

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Three Rs Approaches in the Quality Control of Inactivated Rabies Vaccines: The Report and Recommendations of ECVAM Workshop 48,

Cited by 35 publications

References 15 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

Inactivated Viral Vaccines

Contact Info

Product

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About

Three Rs Approaches in the Quality Control of Inactivated Rabies Vaccines: The Report and Recommendations of ECVAM Workshop 48^,