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将７６例ＨＢｓＡｇ和ＨＢｅＡｇ双阳性母亲所生新生儿随机分为Ａ、Ｂ两组，分别接种３针２０μｇ基因疫苗和１针ＨＢＩＧ加３针１０μｇ基因疫苗。将２３９名乙肝易感学龄儿童（７～９岁）随机分为３组，Ⅰ组接种３针１０μｇ基因疫苗，Ⅱ组接种３针５μｇ基因疫苗，Ⅲ组接种３针１０μｇ血源疫苗。接种程序和接种部位均按＂北京市乙肝疫苗免疫接种规程＂进行，并于初次免疫后７个月、１２个月和２４个月采血检测ＨＢｓＡｇ、抗－ＨＢｓ和抗－ＨＢｃ。结果表明，①新生儿免疫保护率：Ｔ２４时Ａ、Ｂ两组分别为８０．９２％和９６．９７％；用Ｆｉｓｈｅｒ精确ｘ２检验Ｐ＜０．０５，两组间差异有显著性；②新生儿免疫后抗体应答：Ｔ２４时Ａ、Ｂ两组的抗－ＨＢｓ阳转率分别为７０．２７％和９４．７４％，ＧＭＴ（ｍＩＵ／ｍｌ，下同）分别为４９４和３８８，经统计学分析，两组间抗体阳转率差异有显著性，表明，ＨＢＩＧ加３针１０μｇ基因疫苗联合使用效果优于单用３针２０μｇ疫苗组；③学龄儿童３组的抗－ＨＢｓ阳转率：在Ｔ７、Ｔ１２时均在９６％以上，各组间未见显著性差异。在Ｔ２４时，３组的抗－ＨＢｓ阳转率分别为９８．６５％、９７．４０％和９８．６３％，ＧＭＴ为１０６２、５３３和７?
Sixty-six newborn infants born from HBsAg and HBeAg positive mothers were randomly divided into A and B groups and inoculated with 3 doses of 20 μg gene vaccine and 1 dose of HBIG plus 3 doses of 10 μg of gene vaccine respectively. A total of 239 hepatitis B susceptible school-aged children (7-9 years old) were randomly divided into three groups: group I received 3 doses of 10μg gene vaccine, group Ⅱ received 3 doses of 5μg gene vaccine, and group Ⅲ received 3 doses of 10μg blood vaccine. Inoculation procedures and vaccination sites were conducted according to the “Beijing Hepatitis B Vaccine Immunization Protocol” and HBsAg, anti-HBs and anti-HBc were collected at 7, 12 and 24 months after the initial immunization. The results showed that: (1) The rate of neonatal immunization was 80.92% and 96.97% respectively in A and B groups at T24, P <0.05 by Fisher’s exact x2 test, and there was significant difference between the two groups Antibody response in children after immunization: The positive rate of anti-HBs in A and B groups was 70.27% and 94.74% at T24, respectively, and 494 and 388 respectively in GMT (mIU / ml, the same below) Analysis showed that there was a significant difference in antibody positive rate between the two groups, indicating that HBIG combined with 3-pin 10μg gene vaccine was superior to the single-dose 3μg 20μg vaccine group. ③ The positive rate of anti-HBs in school-age children was T7, T12 were more than 96%, no significant differences between groups. At T24, the anti-HBs positive rates in the three groups were 98.65%, 97.40% and 98.63%, respectively, with GMTs of 1062, 533 and 7%