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谭顺革, 金炜翔, 龙润乡, 陈洪波, 李华, 杨丽仙, 陈统球. 甲肝灭活疫苗接种安全性及免疫效果观察[J]. 中国公共卫生, 2002, 18(1): 38-39. DOI: 10.11847/zgggws2002-18-01-20
引用本文: 谭顺革, 金炜翔, 龙润乡, 陈洪波, 李华, 杨丽仙, 陈统球. 甲肝灭活疫苗接种安全性及免疫效果观察[J]. 中国公共卫生, 2002, 18(1): 38-39. DOI: 10.11847/zgggws2002-18-01-20
TAN Shun-ge, . Study on Safety and Effecacy of Inactivated Hepatitis A Vaccine in Rhesus Monkey[J]. Chinese Journal of Public Health, 2002, 18(1): 38-39. DOI: 10.11847/zgggws2002-18-01-20
Citation: TAN Shun-ge, . Study on Safety and Effecacy of Inactivated Hepatitis A Vaccine in Rhesus Monkey[J]. Chinese Journal of Public Health, 2002, 18(1): 38-39. DOI: 10.11847/zgggws2002-18-01-20

甲肝灭活疫苗接种安全性及免疫效果观察

Study on Safety and Effecacy of Inactivated Hepatitis A Vaccine in Rhesus Monkey

  • 摘要: 目的观察甲型肝炎灭活疫苗的安全性及免疫效果.方法挑选甲肝抗体阴性、丙氨酸转氨酶(ALT)正常的健康的恒河猴10只.随机分为5组,每组2只,每只接种1ml甲肝疫苗,分别接种甲肝灭活疫苗吕8株(Lu8)、H2株及史克疫苗.方案:0、4周接种.接种3天内,每天观察有无局部及全身反应.首次注射后每周采静脉血1次,加强1针后每2周采血1次检测抗HAV及ALT,14周后改为每4周采血1次直至46周.每周采粪便2次,连采4周,用KMB17细胞进行病毒分离.4、8周肝组织穿刺作病理学检查.结果接种疫苗后3天内,所有猴子均无局部及全身反应.ALT正常,4、8周肝脏穿刺无特殊组织病理改变.首次注射后2周100%抗体阳转,4周效价为374.8mIU/ml~937mIU/ml.加强1针后抗HAV效价有10倍以上升高,抗体最高达14992mIU/ml,到46周抗体水平持续在2998.4mIU/ml~7496mIU/ml之间,GMT为31.2~34.2.大便传代2次无排毒.结论4批国产甲肝灭活疫苗接种恒河猴具有很好的安全性和可靠的免疫效果.

     

    Abstract: ObjectiveTo study on the safety and efficacy of inactivated hepatitis A vaccine in rhesus monkeys.MethodsTen rhesus monkeys with negative anti-HAV and normal liver function were divided randomly into 5 groups.Two animals for 1 specimen,1ml specimen of Lu8,H2 strain and SKB vaccines were injected by IM into rhesus respectively at 0th、4th week.The local and body reaction were observed within 3 day after injection.The blood test for anti-HAV and ALT were detected at once every week.The same test did once every two weeks after second inoculation,and once every month within 14th-46th weeks.HAV was isolated and identified by KMB17 cells/EIA from feces collected at twice in 1-4 weeks postinoculation.Liver puncture was performed at 46th week for examing liver histopathology by routine sections with H-E staining.ResultsLocal and body reaction was not observed in all rhesus monkey within 3 day after vacination,no elevation of ALT and liver histopathological change in all rhesus monkeys.Tbe seroconversion rate of anti-HAV was 100% at second week after first inoculation.The valence of antibody was 374.8-937mIU/ml at 4th week.The titer of antibody got up>10 fold after booster inoculation,and kept 2 998.4mIU/ml-7 496mIU/ml at 46th weeks.GMTs were 31.2-34.2.Two passages of feces were negative for HAV.ConclusionFour batchs of inactivated HAV vaccines has good effectiveness and safety.

     

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