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Establishment of animal model for potency evaluationof inactivated SARS virus experimental vaccine

Journal of Microbiology and Immunology 2005年第1期3卷 53-60页

作者： GUANMUDONG QIAN YANKONG WENXUELIU LIHINGYANG JUNZHIWANG YONGXINYU YAOLONGSHU ZHENGWANG WEIDONGYIN QINGYUZHU HAIFAZHENG NationalInstitutefortheControlofPharmaceuticalandBiologicalProducts BeijingP.R.China BeijingJindikeBio-TechnologyInstitute BeijingP.R.China SinovacBiotechCo.Ltd.39ShangdiXiRoad HaidianDistrictBeijingP.R.China MicrobiologyandEpidemicInstituteofAcademyofMilitaryMedicalScience BeijingP.R.China HuatesenGeneCo.Ltd BeijingP.R.China

The purpose of this study was to test the effectiveness of source virus strain for the manufacture of the inactivated SARS virus vaccine, and establish an experimental method and preliminary standard for potency evaluation. Mice were divided into groups for being immunized with corresponding serially diluted experimental SARS virus inactivated vaccine. And the rabbits were immunized with undiluted vaccine. Challenge assay was conducted with a heterologous SARS virus. And the neutralization antibody was determined with plaque reduction neutralization test (PRNT), to which the neutralization antibody in the convalescent serum of SARS patients was compared. The experimental vaccine viral strains were proved to be suitable for manufacturing the vaccine. Mice immunized by vaccines of serial dilutions were able to elicit neutralizing antibody. The antibody titer from mice immunized with the undiluted vaccine could reach up to 1∶495.2, while those of rabbits immunized with the undiluted vaccine could reach a GMT of 55.0-79.9. The capability of the antibody to neutralize the virus from Guangdong is more efficient than that from Beijing. The GMT of neutralizing antibody in SARS convalescents living in south and north China ranged from 50.12 to 54.95, and the titers of convalescents from north China were higher than those from south China. Mice and rabbits used as the model for evaluation of potency are of sensitivity, and the test is of reproducibility. The candidate challenge viral strains showed a relatively consistent effect on evaluating antibodies produced by various batches and different vaccine-source strains, hence they can be used to evaluate potency of the vaccine. The method for testing the vaccine potency and the evaluation standard was established preliminarily.

关键词： SARS virus Inactivated vaccine Neutralizing antibody potency assay Plaque reduction neutralization test(PRNT)

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A Semi-quantitative Serological Method to Assess the potency of Inactivated Rabies Vaccine for Veterinary Use

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Virologica Sinica 2012年第4期27卷 259-264页

作者： Ye Liu Shoufeng Zhang Fei Zhang Rongliang Hu Laboratory of Epidemiology Military Veterinary Research InstituteAcademy of Military Medical SciencesChangchun 130122China

potency is one of the most important indexes of inactivated vaccines.A number of methods have been established to assay the potency,of which the NIH test and single-dose mouse protection test are the "prescribed methods".Here,we report a method to semi-quantitatively assay the potency of an inactivated rabies vaccine,which uses fewer animals and takes less time to *** on the quality requirements of a vaccine(*** potency),a rabies reference vaccine is,for example,diluted to the minimum potency,and 50 μL of the dilution is taken to inoculate 10 *** same amount of the test rabies vaccine is inoculated into another 10 *** two weeks,all mice are bled and serum samples are assayed for viral neutralizing antibody by the fluorescent antibody virus neutralization(FAVN) *** comparing the median and interquartile range of antibody titers of the reference vaccine with those of the test vaccine,the test vaccine potency can be semi-quantitatively judged as to whether it is in accord with the required *** reliability of this method was also confirmed in *** procedure can be recommended for batch potency testing during inactivated rabies vaccine production.

关键词： Rabies Inactivated vaccine potency assay Semi-quantitative method

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