| 时景璞,李征远,郑力国,徐占民,王桂花,王昕,张群弟,杨志齐,孙宏章,郭乃全,梁争论,吴晓音.重组酵母乙型肝炎疫苗对成人的免疫效果及安全性的研究[J].Chinese journal of Epidemiology,2001,22(2):105-107 |
| 重组酵母乙型肝炎疫苗对成人的免疫效果及安全性的研究 |
| Immunogenicity and safety of recombinant yeast -derived hepatitis B vaccine( YDV)on adults |
| Received:October 15, 2000 |
| DOI： |
| KeyWord: 重组酵母乙型肝炎疫苗 抗体阳转率 抗体几何平均滴度 |
| English Key Word: Recombinant yeast-derived hepatitis B vaccine(YDV) Positive rates of anti -HBs Mean geometric titre( GMT)of anti-HBs |
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| Abstract: |
| 目的探讨重组酵母乙型肝炎疫苗(YDV)对成人的免疫效果及安全性。方法在辽宁省北票市部分学校选择一般健康状况良好，乙型肝炎表面抗原(HBsAg)、乙型肝炎表面抗体(抗HBs)、乙型肝炎核心抗体(抗HBc)三项指标均为阴性，体温正常的22～58岁的教师，随机抽取124名，按0、1、6个月程序，每剂5μg/0.5ml接种卫生部北京生物制品研究所生产的重组酵母乙型肝炎疫苗。结果免疫后3、7、12个月时，抗HBs阳转率分别为35.0%、83.3%、67.2%(P<0.01)。抗HBs平均滴度分别为12.63mIU/ml、402.04mIU/ml、70.28mIU/ml(P<0.01);抗HBs阳转率及其滴度均在7个月时达到高峰，以后又急剧下降。免疫后3、7、12个月时，女性抗HBs阳转率和滴度均高于男性。但仅抗HBs滴度在免疫后3个月时两者之间差异有显著性;小于35岁组的抗体阳转率高于35岁以上组，但仅在免疫后12个月时两者之间差异有显著性;而该两个年龄组间的抗HBs滴度差异无显著性;免疫3d后局部和全身未见不良反应。结论重组酵母乙型肝炎疫苗对成人具有良好的免疫原性和安全性，其抗HBs持续时间有待进一步观察。 |
| English Abstract: |
| ObjectiveTo study the immunogenicity and safety of recombinant yeast-derived hepatitis B vaccine ( YDV)on adults. Methods One hundred twenty-four healthy teachers of 22-58 years old, were randomly selected in Beipiao city, Liaoning province.Their HBsAg, anti-HBs and anti -HBc were all negative and temperature was normal.They were vaccinated with 5 μ g/ 0. 5 ml of YDV, which was made in Beijing Institute of Biologic Products, at 0, 1, 6 months.Results The positive rates of anti -HBs were 35. 0%, 83. 3%, 67. 2%( P <0. 01)with the mean geometric titre( GM T)of anti -HBs 12. 63 mIU/ml、402. 04 mIU/ml and 70. 28 mIU/ml(P<0. 01)at 3th, 7th, 12th months respectively.The positive rates of anti-HBs and GMT of anti -HBs became the highest at 7th month, then began to decrease sharply.At 3th, 7th, 12th months the positive rates of anti-HBs and GM T of anti-HBs were higher on female compared to male, but only GM T of anti -HBs was significantly different at 3th month; the positive rates of anti -HBs in below 35 years old group was higher than 35 and over years old group, but it was significantly different only at 12th month. GMT of anti-HBs between the two groups was no obvious difference.Local or systematic addictive reactions were not found in all the subjects in 3 days after injection.Conclusion YDV is effective and safety to adults.The duration of anti -HBs should be further observed. |
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