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[目的]评价接种酵母重组乙肝疫苗 (基因疫苗 )的免疫效果与免疫持久性 ,为基因疫苗的推广应用及高危新生儿乙型肝炎的预防提供依据。[方法]1985年～1986年HBsAg ( +)产妇93例及所生的新生儿94例 ,按0、1、6免疫程序接种美国Merck基因疫苗 (5μg/剂 ) ;分别于免疫接种后6个月、12个月及12周岁后采血用放射免疫法 (RIA)作HBsAg及抗 HBs检测。[结果]新生儿接种基因疫苗12年后 ,母亲HBsAg 阳性但HBeAg阴性者 (单阳性 )的HBsAg阳性率为4.17% ,显著低于母亲HBsAg 及HBeAg均阳性者 (双阳性 )的23.40 % (P<0.05)。两组对象12周岁时的免疫保护率分别为91.66 %与74.00 %。联合使用乙肝免疫球蛋白(HBIG)并未显示出能提高基因疫苗接种者的HBsAg阻断率及抗 HBs血清阳转率 (P>0.05)。[结论]Merck基因疫苗的短期和远期免疫效果可以肯定 ,其对于乙肝高危产妇所生儿童的有效保护率至少可以持续12年。联合使用HBIG并不增加基因疫苗的长期免疫效果。基因疫苗可以取代乙肝血源疫苗 ,并将在乙肝免疫预防中发挥重要的作用
[Objective] To evaluate the immune effect and immune persistence of recombinant hepatitis B vaccine (gene vaccine) inoculated with yeast and provide the basis for the popularization and application of gene vaccines and the prevention of hepatitis B in high-risk neonates. [Methods] 93 cases of HBsAg (+) mothers and 94 newborn infants born from 1985 to 1986 were vaccinated with Merck gene vaccine (5μg / dose) according to the 0,1,6 immunization program. Six months after immunization Months, 12 months and 12 years of age after blood collection by radioimmunoassay (RIA) for HBsAg and anti-HBs test. [Results] The positive rate of HBsAg in mothers with HBsAg positive but HBeAg negative (single positive) was 4.17% 12 years later, which was significantly lower than that of mothers with positive HBsAg and positive HBeAg (double positive) of 23.40% (P <0.05). The immune protection rates at 12 years of age in both groups were 91.66% and 74.00% respectively. Combined use of HBIG did not show an increase in HBsAg blocking and anti-HBs seroconversion (P> 0.05) among gene vaccines. [Conclusion] The short-term and long-term immunization effects of Merck gene vaccine can be affirmed. The effective protection rate of Merck gene vaccine for children born at high risk of hepatitis B can last for 12 years. Combined use of HBIG does not increase the long-term immunization of gene vaccines. Gene vaccine can replace hepatitis B blood vaccine, and will play an important role in hepatitis B immune prevention