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用国产基因工程乙肝疫苗 5μg/支 x 3按 0、1、 2程序对134名新生儿(母亲产前 HBsAg(+) 47名,HBsAg(-)87名)免疫接种,免后观察12个月。结果新生儿接种疫苗后均无局部及全身不良反应。免后 T7、 T12抗-HBs阳性率分别为 83.58%及 87.40%;抗- HBs滴度均值分别为 157.56、 126.92。免前检测抗-HBs(-)的67名新生儿,免后T7及T12检测抗-HBs阳转率分别为80.60%(54/67)、83.58%(56/67),免后T7检出HBsAg阳性婴儿2名,阳性率4.26%(占母亲HBsAg(+)),乙肝传播阻断率(保护率)91.48%。结果显示,乙肝基因疫苗具有良好的安全性和免疫原性,可取代血源性乙肝疫苗进行全面推广应用。
134 newborn babies (mothers prenatal HBsAg (+) 47, HBsAg (-) 87) were vaccinated with domestic genetic engineering hepatitis B vaccine 5μg / branch x 3 according to the 0,1,2 procedures. After 12 months . Results No neonatal local and systemic adverse reactions after vaccination. The positive rates of T7 and T12 anti-HBs were 83.58% and 87.40% respectively after immunization. The mean titers of anti-HBs were 157.56 and 126.92, respectively. Pretreatment anti-HBs (-) in 67 newborns, after free T7 and T12 detection of anti-HBs positive rates were 80.60% (54/67), 83.58% (56/67), respectively After T7 detected 2 HBsAg positive infants, the positive rate of 4.26% (accounting for the mother HBsAg (+)), hepatitis B transmission rate (protection rate) 91.48%. The results showed that the hepatitis B gene vaccine has good safety and immunogenicity, which can replace the blood-borne hepatitis B vaccine for comprehensive promotion and application.