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用比较

Comparing Immunogenicity and Efficacy of Two Hepatitis B Vaccines in Newborn Infants of Hepatitis B Surface Antigen (+)/Hepatitis B e Antigen (+) Carrier Mothers

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（ Ｈ Ｂｓ Ａｇ） 及ｅ 抗原阳性（ 双阳） 母亲分娩的新生儿的保护效果及副反用，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 例，注射血源乙肝疫苗３０ Ｕ。均于出生后２４ 小时、１ 个月、６ 个月注射，每次注射前及出生９ 个月时抽取静脉血，检查乙肝病毒脱氧核糖核酸片段（ Ｈ Ｂ Ｖ Ｄ Ｎ Ａ）（ Ｐ Ｃ Ｒ 及斑点杂交法） 、 Ｈ Ｂｓ Ａｇ（ Ｅ Ｌ Ｉ Ｓ Ａ） 、乙型肝炎表面抗体（ Ｈ Ｂｓ Ａｂ） （ Ｒ Ｉ Ａ） 、肝功能等，并观察副反应。结果 （１） 试验组出生６ 、９ 个月后， Ｈ Ｂ Ｖ 持续感染率分别为７ ．８９ ％ 、５ ．２６ ％ ，均低于对照组（１４ ．６３ ％ 、１７ ．０７ ％ ） ，但差异无显著性；（２） 试验组疫苗保护率（ Ｖ Ｅ） 为９３ ．８２ ％ ，对照组为７９ ．９２ ％ ；（３） 出生９ 个月时试验组 Ｈ Ｂｓ Ａｂ 阳性率为９４ ．７４ ％ ，对照组为８０ ．４９ ％ ，两组比较差异有显著性（ Ｐ＜ ０ ．０５） ；（４） 两组副反应发生率比较，差异无显著性。结论 酵母重组基因工程乙肝疫苗对乙肝双阳?

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( 5mcg/0.5ml)] 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.