| Establishment of animal model for potency evaluationof inactivated SARS virus experimental vaccine |
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| 作者单位： | GUAN MU DONG 1，QI AN 1，YAN KONG 1，WEN XUE LIU 1，LI HONG YANG 1JUN ZHI WANG 1，YONG XIN YU 1，YAO LONG SHU 2，ZHENG WANG 2，WEI DONG YIN 3，QING YU ZHU 4 and HAI FA ZHENG 5 1 National Institute for the Control of Pharmaceutical and Biological Products，Beijing，P.R.China 2 Beijing Jindike Bio-Technology Institute，Beijing，P. R. China 3 Sinovac Biotech Co.Ltd. 39 Shangdi Xi Road，Haidian District，Beijing，P.R.China 4 Microbiology and Epidemic Institute of Academy of Military Medical Science，Beijing，P.R.China 5 Huatesen Gene Co.Ltd，Beijing，P. R. China. |
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| 摘 要： | The SARS outbreak in China has made governmentto organize a comprehensive collaborative study forevery aspect of SARS. A great progress has beenmade in the research of SARS basically, clinicallyand epidemiologically. Meanwhile, thanks to in ternational cooperation, we have now known thatSARS is caused by a human coronavirus (HCoV).The classical method for the development of vac cine by inactivating virus in tissue culture is afastest, safe and effective one [1,2]. SARS HCoV…
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| 关 键 词： | 动物模型 SARS 非典型性肺炎 病毒感染 疫苗治疗 |
Establishment of animal model for potency evaluation of inactivated SARS virus experimental vaccine |
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| GUANMUDONG QIAN YANKONG WENXUELIU LIHINGYANG JUNZHIWANG YONGXINYU YAOLONGSHU ZHENGWANG WEIDONGYIN QINGYUZHU HAIFAZHENG. Establishment of animal model for potency evaluation of inactivated SARS virus experimental vaccine[J]. Chinese Journal of Microbiology and Immunology, 2005, 3(1): 53-60 |
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| Authors: | GUANMUDONG QIAN YANKONG WENXUELIU LIHINGYANG JUNZHIWANG YONGXINYU YAOLONGSHU ZHENGWANG WEIDONGYIN QINGYUZHU HAIFAZHENG |
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| Affiliation: | [1]NationalInstitutefortheControlofPharmaceuticalandBiologicalProducts,Beijing,P.R.China [2]BeijingJindikeBio-TechnologyInstitute,Beijing,P.R.China [3]SinovacBiotechCo.Ltd.39ShangdiXiRoad,HaidianDistrict,Beijing,P.R.China [4]MicrobiologyandEpidemicInstituteofAcademyofMilitaryMedicalScience,Beijing,P.R.China [5]HuatesenGeneCo.Ltd,Beijing,P.R.China |
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| Abstract: | 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. |
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| Keywords: | SARS virus Inactivated vaccine Neutralizing antibody Potency assay Plaque reduction neutralization test(PRNT) |
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