Liu Y, Liu X, Kuang J
Sun Yat-sen Memorial Hospital, Sun Yat-sen University of Medical Sciences, Guangzhou, 510120.
Zhonghua Fu Chan Ke Za Zhi. 1999 Aug;34(8):470-2.
To evaluate the effect of yeast recombinant HBV vaccine on protecting the newborns from HBV carrier mothers and to compare with plasma-derived vaccine.
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.
(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.
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.
评估酵母重组乙肝疫苗对乙肝表面抗原（HBsAg）和乙肝e抗原（HBeAg）双阳性母亲所生新生儿的保护效果，并与血源疫苗进行比较。
117例母亲为HBsAg(+)/HBeAg(+)携带者的新生儿参与本研究。研究组（76例接种重组酵母乙肝疫苗[RECOMBIVAX HB，5微克/0.5毫升]）和对照组（41例新生儿接种血源疫苗）分别于出生后0、1、6、9个月采集血样并接种疫苗。分别采用聚合酶链反应（PCR）、酶联免疫吸附测定（ELISA）、放射免疫分析（RIA）检测乙肝病毒脱氧核糖核酸（HBV-DNA）、HBsAg/HBeAg、乙肝表面抗体（HBsAb）。
（1）研究组6个月和9个月龄儿童慢性乙肝病毒感染率分别为7.89%、5.26%，低于对照组（14.63%、17.07%）。（2）研究组疫苗效力（VE）为93.82%，对照组为79.92%。（3）研究组9个月龄时HBsAb阳性率为94.74%，显著高于对照组（80.49%）（P<0.05）。（4）两组不良反应发生率差异无统计学意义。
对于HBsAg(+)/HBeAg(+)携带者母亲所生新生儿，酵母重组乙肝疫苗的免疫原性和效力优于血源疫苗。
