Abstract |
Potency controls of inactivated rabies vaccines for human use are confirmed by the National Institutes of Health challenge test in which lethal infection with severe neurological symptoms should be observed in approximately half of the mice inoculated with the rabies virus. Weight loss, decreased body temperature, and the presence of rabies-associated neurological signs have been proposed as humane endpoints. The potential for reduction of animal suffering by introducing humane endpoints in the potency test for inactivated rabies vaccine for human use was investigated. The clinical signs were scored and body weight was monitored. The average times to death following inoculation were 10.49 and 10.99 days post-inoculation (dpi) by the potency and challenge control tests, respectively, whereas the average times to showing Score-2 signs ( paralysis, trembling, and coma) were 6.26 and 6.55 dpi, respectively. Body weight loss of more than 15% appeared at 5.82 and 6.42 dpi. The data provided here support the introduction of obvious neuronal signs combined with a body weight loss of ≥15% as a humane endpoint to reduce the time of animal suffering by approximately 4 days.
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Authors | Mutsuyo Takayama-Ito, Chang-Kweng Lim, Kazuo Nakamichi, Satsuki Kakiuchi, Madoka Horiya, Guillermo Posadas-Herrera, Ichiro Kurane, Masayuki Saijo |
Journal | Biologicals : journal of the International Association of Biological Standardization
(Biologicals)
Vol. 46
Pg. 38-45
(Mar 2017)
ISSN: 1095-8320 [Electronic] England |
PMID | 28040390
(Publication Type: Journal Article)
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Copyright | Copyright © 2017 International Alliance for Biological Standardization. Published by Elsevier Ltd. All rights reserved. |
Chemical References |
- Rabies Vaccines
- Vaccines, Inactivated
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Topics |
- Animals
- Body Weight
(immunology)
- Chick Embryo
- Female
- Humans
- Mice
- Rabies
(immunology, mortality, virology)
- Rabies Vaccines
(immunology)
- Rabies virus
(immunology)
- Survival Analysis
- Survival Rate
- Time Factors
- Vaccination
(methods)
- Vaccine Potency
- Vaccines, Inactivated
(immunology)
- Weight Loss
(immunology)
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