酵母重组基因工程乙型肝炎疫苗与血源疫苗对新生儿的保护作？…

目的 评价酵母重组基因工程乙型肝炎（乙肝）疫苗对乙肝表面抗原（ＨＢｓＡｇ）及ｅ抗原阳性（双阳）母亲分娩的新生儿的保护效果及副反应,并与血源乙肝疫苗比较。方法 将１１７例双阳母亲分娩的新生儿,分为试验组７６例,注射酵母重组基因工程乙肝疫苗５μｇ,对照组４１注射血源乙肝疫苗３０Ｕ,均于出生后２４小时、１个月、６个月注射,每次注射前扩及出生９个月时抽取静脉血,检查乙肝病毒脱氧核糖核酸片段（ＨＢＶ－ＤＮＡ

Comparing immunogenicity and efficacy of two hepatitis B vaccines in newborn infants of hepatitis B surface antigen (+)/hepatitis B e antigen (+) carrier mothers

OBJECTIVE: To evaluate the effect of yeast recombinant HBV vaccine on protecting the newborns from HBV carrier mothers and to compare with plasma-derived vaccine. METHODS: There were 117 neonates from HBsAg(+)/HBeAg(+) carrier mothers involved in the study. Study group 76 of them received RECOMBIVAX HB(5 mcg/0.5 ml)] and control group (41 neonates receive plasma derived vaccine) had blood samples collected and received vaccine at 0, 1, 6, 9 month after birth respectively. HBV-DNA, HBsAg/HBeAg, HBsAb were determined by PCR, ELISA, RIA independently. RESULTS: (1) Children chronic HBV infection rates at 6, 9 month of age in study group were 7.89%, 5.26% respectively, which were lower than that of control group(14.63%, 17.07%). (2) The vaccine efficacy (VE) in study group was 93.82%, vs, that of control group was 79.92%. (3) The HBsAb positive rate in study group at 9 month of age was 94.74% which was significantly higher than that of control group(80.49%) (P < 0.05). (4) The difference of side-effect rates between the two groups was not significant. CONCLUSION: Immunogenicity and efficacy of yeast-recombinant hepatitis B vaccine is better than that of plasma derived vaccine in newborn infants of HBsAg(+)/HBeAg(+) carrier mothers.