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[乙型肝炎减毒活疫苗(H2株)人体安全性观察]

[Safety observation of attenuated live hepatitis B vaccine (H2 strain) in humans].

作者信息

Zhang S

出版信息

Zhonghua Yi Xue Za Zhi. 1990 Dec;70(12):682-4, 48.

PMID:1963372
Abstract

3089 healthy persons, aged 4 to 27 years, have been inoculated in 3 batches with attenuated live hepatitis A vaccine (H2 strain) since May, 1987. Each subject received 10(8.5) TCID dosage subcutaneously in the upper arm. None of the recipients developed any local or systemic reaction during a 42-day followup after vaccination. The serum enzyme activities, including SGPT/ALT and LDH5, were within normal range during the 4th to 16th weeks of serial tests after inoculation. The study of hepatitis A virus (HAV) shedding in feces of 4 subjects showed that no hepatitis A antigen (HAAg) was detected with antigen capture ELISA, but infectious HAV was recovered from stool-cell cultures in three of four recipients. No patient with hepatitis A was found within 6 months after vaccination in the institution where the HAV vaccine was used. In addition, no immunological evidence was seen that the HAV vaccine recipients can transmit HAV after the investigation of serological epidemiology at a class in which the HAV vaccine was tested. It is suggested that the potential of hepatitis A related to HAV vaccine among the non-vaccinated persons is rare. Seroconversion occurred at a mean time of 2 to 5 weeks after inoculation, and the positive rate of specific antibody was 95.6%.

摘要

自1987年5月以来,分3批对3089名年龄在4至27岁的健康人接种了甲型肝炎减毒活疫苗(H2株)。每位受试者在上臂皮下接种10(8.5)TCID剂量。接种疫苗后42天的随访期间,所有接种者均未出现任何局部或全身反应。接种后第4至16周的系列检测中,血清酶活性,包括SGPT/ALT和LDH5,均在正常范围内。对4名受试者粪便中甲型肝炎病毒(HAV)排出情况的研究表明,用抗原捕获ELISA未检测到甲型肝炎抗原(HAAg),但4名接种者中有3名从粪便细胞培养物中分离出了有传染性的HAV。在使用HAV疫苗的机构中,接种疫苗后6个月内未发现甲型肝炎患者。此外,在对一个班级进行甲型肝炎疫苗检测的血清流行病学调查后,没有发现免疫证据表明接种HAV疫苗的人会传播HAV。提示在未接种疫苗人群中,与HAV疫苗相关的甲型肝炎发生可能性很小。接种后血清阳转平均发生时间为2至5周,特异性抗体阳性率为95.6%。

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[Safety observation of attenuated live hepatitis B vaccine (H2 strain) in humans].[乙型肝炎减毒活疫苗(H2株)人体安全性观察]
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Safety and immunogenicity of live attenuated hepatitis A virus vaccine (H2 strain) in humans.甲型肝炎减毒活疫苗(H2株)在人体中的安全性和免疫原性。
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[Epidemiological effects of live attenuated hepatitis A vaccine (H(2)-strain): results of A 10-year observation].甲型肝炎减毒活疫苗(H2株)的流行病学效果:10年观察结果
Zhonghua Liu Xing Bing Xue Za Zhi. 2001 Jun;22(3):188-90.

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A review of immunogenicity and tolerability of live attenuated Hepatitis A vaccine in children.儿童甲型肝炎减毒活疫苗的免疫原性和耐受性综述。
Hum Vaccin Immunother. 2016 Dec;12(12):3160-3165. doi: 10.1080/21645515.2016.1216286.
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Viral hepatitis vaccination during pregnancy.孕期接种病毒性肝炎疫苗。
Hum Vaccin Immunother. 2016 Apr 2;12(4):894-902. doi: 10.1080/21645515.2015.1132129.
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Era of vaccination heralds a decline in incidence of hepatitis A in high-risk groups in China.疫苗接种时代预示着中国高危人群中甲肝发病率的下降。
Hepat Mon. 2012 Feb;12(2):100-5. doi: 10.5812/hepatmon.838. Epub 2012 Feb 29.