A reference vaccine for potency tests of rabies vaccines
1990
Senda, M. (Japan. Ministry of Agriculture, Forestry and Fisheries, Kokubunji, Tokyo. National Veterinary Assay Lab.) | Hirayama, N. | Itoh, O. | Yamamoto, H. | Kurata, K.
An inactivated and lyophilized rabies vaccine was prepared as a reference vaccine for potency tests. The RCEH strain was propagated in chick embryo fibroblast cells and inactivated by beta-propiolactone to prepare the vaccine. The vaccine was subjected to general tests on minimum requirements for inactivated rabies vaccine or other dog vaccines. For each potency test, 10 guinea pigs were inoculated subcutaneously with 0.5 ml of tenfold dilution of the vaccine. Three weeks after vaccination, they were challenged with 10 LD50 of CVS strain of rabies virus by intramasseteric route. The potency was found to be stable with a protection rate of around 90% (88.4 +- 8.35%) among 27 tests performed over a period of 6 years. Similar results were obtained in tests carried out in collaboration with several vaccine manufacturers. This vaccine induced a sufficient amount of neutralizing antibody when it was inoculated to dogs. These results suggest that the present reference vaccine exhibits adequate potency, and that similar vaccines with an adequate potency give reproducible results in the current potency test for rabies vaccine using guinea pigs. This reference vaccine will be useful for validation potency tests
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