乙型肝炎基因工程疫苗母婴阻断及儿童免疫效果

The Efficacy of a Recombinant Vaccine against Type B Hepatitis Prepared by Genetic Engineering in Interruption of Perinatal Transmission and Immunization of School-aged Children

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?

Seventy-six newborn babies who had been borne from HBsAg (+) and HBeAg (+) mothers were randomly divided into Group A and Group B, and were inoculated with 3 injections of 20μg genetic engineering vaccine and with 3 injection of hightiter immunoglobulin against HBV plus 3 injections of 10μg genetic engineering vaccine, respectively. Two-hundred and thirty-nine school-aged children(aged 7-9 years) who were susceptible to type B hepatitis were randomly divided into 3 groups.Group Ⅰ received 3 injections of 10μg genetic engineering vaccine. Group Ⅱ received 3 injections of 5μg genetic engineering vaccine. Group Ⅲ received 3 injections of 10μg blood-derived vaccine. The procedure and site of injection were taken according to the 'Beijing Immunization Regulations for Type B Hepatitis'. Blood was collected at 7 months, 12 months and 24 months after the first injection and assayed for HBsAg, anti-HBs and anti-HBc. Results showed that: (1) The immune protection rates of newborn babies: They were 80.92% and 96.97% for Group Ⅰ and Group Ⅱ, respectively at 24 months. The difference was significant as examined by the Fisher accurate X2 test (P < 0.05). (2) The antibody response after immunizstion of newborn babies: The anti-HBs positive conversion rates of Group Ⅰ and Group Ⅱ at 24 months were 70.27% and 94.74%, respectively. and theGMT (mIU / ml) were 494 and 388, respectively. Statistical analysis disclosed that the difference in antibody positive conversion rates was significant, showing that the efficacy of Group Ⅱ was superior to that of Group Ⅰ. (3) The anti-HBs conversion rates of 3 groups of school-aged children: They were all over 96% at 7 months and 12 months. There was no significant difference among them. At 24 months, the anti-HBs conversion rates of 3 groups were 98.65%, 97.40% and 98.63%, respectively, and the GMT of Group Ⅰ was higher than that of Group Ⅲ, and those of both Group Ⅰ and Group Ⅲ were higher than that of Group Ⅱ.