重组乙型肝炎疫苗母婴传播阻断效果的研究

A Study of Interrupting Mother - to - Infant Transmission of Hepatitis B Virus Using Different Recombinant Hepatitis B Vaccines in China

目的 比较不同种类乙肝疫苗的免疫效果。方法 1994～1999年间,应用7批国产重组酵母乙肝疫苗,4批国产重组CHO乙肝疫苗,以及美国MSD公司(Recombivax-HB),Amgen公司和比利时Smith Kline Beecham公司(Engeris B)生产的重组酵母乙肝疫苗各一批,按0、1和6个月免疫程序免疫614名新生儿,其中416名新生儿母亲为HBsAg、HBeAg双阳性,81名新生儿母亲为HBsAg阳性HBeAg阴性,117名新生儿母亲HBV感染指标阴性。结果在1年的观察期间中,178名免疫国产重组酵母乙肝疫苗的新生儿有22名HBsAg持续阳性,母婴传播阻断率在80.56％～92.59％之间,显著高于国产重组CHO乙肝疫苗(75.43％);3批国外酵母疫苗的阻断率分别为90.33％、86.59％和92.59％。未见抗体GMT和母婴传播阻断率间有相关关系。酵母疫苗高的传播阻断率可能与其诱导细胞免疫较早有关。结论 国产酵母乙肝疫苗的母婴传播阻断保护率达到国外同类疫苗水平。

Objective To evaluate the immune effcacy of different recombinant hepatitis B vaccines. Methods From 1994 to 1999, 7 lots recombinant yeast derived hepatitis B Vaccines manufactured in China (CYDV) , 4 lots recombinant Chinese hamster o-vary cells derived hepatitis B vaccines in China (CCDV) , 1 lot MSD YDV (MYDV; Recombivax - HB), Amgen YDV (AYDV) and Smith Kline Beecham YDV (SBYDV; Engeris B) were used to immunize 614 infants at birth in China according 0, 1 and 6 months schedule. Of the 614 infants, 417 were born from HBsAg and HBeAg positive mothers, 81 were from mono - HBsAg positve mothers, while 117 were form health mothers. Results Of the 178 infants received CYDV, during one year study, 22 cases HBsAg persist detected, and the PE range of 7 lots were from 80.56% to 92.59%, significantly higher than that of CCDV. For the control vaccine the PE of MYDV, AYDV and SBYDV are 90.33% , 86.59% and 92.59% , respectively. No relation between PE and anti -HBs GMT was found. The high PE of yeast derived hepatitis B vaccine might be attribute to no glycosylated of this vaccine. Condu-sions The protective efficacy of transmission interruption from mothers to infants with 5pig yeast derived hepatitis B vaccines made in China was the same level with yeast vaccines produced in other counties.