两种基因工程乙型肝炎疫苗随机化临床比较研究

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方法 用酵母乙肝基因疫苗 (A苗 )和含前S2抗原乙肝基因疫苗 (B苗 ) ,接种成人、儿童与HBsAg和HBeAg双阳性母亲的新生儿 ,采用 0、1、6月接种方案 ,于免后 1、6、7个月采血 ,用Abbott MEIA试剂检测。结果 第 7个月时 ,成人、儿童和新生儿抗HBs阳转率和几何均数分别为 (除注明外 ,其余均为 5 μg/针 ) 89 4%、 147 16mIU/ml (成人A ) ;89 6 %、2 92 48mIU/ml(成人B) ;97 8%、831 19mIU/ml(成人B :10 μg/针 ) ;10 0 %、 5 5 1 5 7mIU/ml (儿童A ) ;10 0 %、979 2 6mIU/ml(儿童B) ;90 5 %、2 82 88mIU/ml(新生儿A +HBIG) ;80 8%、2 6 5 5 2mIU/ml(新生儿B +HBIG) ;84 1%、180 0 9mIU/ml(新生儿A)和 71 1%、117 6 3mIU/ml(新生儿B)。分析结果表明 ,两种疫苗在使用剂量和方案相同时 ,免后抗HBs阳转率、几何均数以及新生儿HBsAg阳性率都没有统计学差别。 7个月两种疫苗母婴阻断率分别为 :83 8% (A +HBIG)、89 1% (B +HBIG)、81 9% (A)和 6 7 2 % (B)。结论 上述两种乙肝基因疫苗的安全性、免疫原性和阻断乙肝病毒母婴传播近期效果相似。 Methods Newborns with both HBsAg and HBeAg-positive mothers were inoculated with yeast hepatitis B gene vaccine (A vaccine) and pre-S2 antigen-containing hepatitis B gene vaccine (B vaccine), and were vaccinated with 0, 1 and 6 months Blood samples were taken at 1, 6, and 7 months after Abbott MEIA. Results At 7 months, the rates and geometric mean anti-HBs positive rates in adults, children and newborns were 89 4% and 147 16 mIU / ml, respectively (Adult A) (Adult B: 10 μg / needle); 10 0%; 5 5 1 57 mIU / ml (for children A); 10 8%; 831 19 mIU / ml (Neonatal A + HBIG); 80 8%, 25 65mIU / ml (neonatal B + HBIG); 84% 1%, 180 9mIU / ml (newborn A) and 71 1%, 117 6 3mIU / ml (newborn B). The results showed that the two vaccines at the same dose and protocol, no post-anti-HBs positive rate, geometric mean and HBsAg positive rate of newborns no statistically significant difference. The blocking rates of the two vaccines at 7 months were 83 8% (A + HBIG), 89 1% (B + HBIG), 81 9% (A) and 6 72% (B) respectively. Conclusion The safety and immunogenicity of the two hepatitis B gene vaccines mentioned above are similar to those of blocking the mother-to-child transmission of hepatitis B virus.
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