摘要
目的 以血源乙型肝炎疫苗为对照 ,评估国产重组酵母乙型肝炎疫苗单用或联合乙型肝炎免疫球蛋白 (HBIG)对乙型肝炎病毒 (HBV)母婴传播的阻断效果。方法 以乙型肝炎表面抗原阳性母亲的婴儿为观察对象。其中 117名接种 30 μg血源乙型肝炎疫苗 (血源疫苗组 ) ,99名接种 5 μg酵母重组乙型肝炎疫苗 (基因疫苗组 )。均随机分为单用疫苗或联合免疫 ,单用疫苗者按 0、1、6个月程序接种 ,联合免疫者出生时和出生后 2周时各注射HBIG 10 0IU ,然后于 1、2、7个月龄接种疫苗。结果单用疫苗时 ,1、3、6、12个月龄抗 HBs阳性率在血源疫苗组分别为 11.3%、41.2 %、6 2 .7%、80 .9% ;基因疫苗组为 8.2 %、41.7%、5 8.3%、77.3% ;慢性HBV感染率血源疫苗组为 10 .6 % ,基因疫苗组为 9.1%。联合免疫时 ,1、4、7、12个月龄抗 HBs阳性率在血源疫苗组为 6 7.2 %、6 9.4%、85 .0 %、87.3% ;基因疫苗组为70 .7%、5 3.1%、5 0 .0 %、89.1% ;慢性HBV感染率血源疫苗组为 5 .5 % ,基因疫苗组为 6 .5 % ,两种疫苗间除联合免疫时 7个月龄抗 HBs阳性率差异有显著性 (χ2 =15 .39,P <0 .0 0 5 ) ,其余指标差异无显著性。结论 国产 5 μg重组酵母乙型肝炎疫苗阻断HBV母婴传播的效果和 30 μg血源疫苗相仿。
Objective To compare the efficacy of plasma derived hepatitis B vaccine (pHBvac) with domestically made recombinant yeast derived hepatitis B vaccine (rHBvac) for interruption of hepatitis B virus (HBV) maternal infantile transmission. Methods Serum hepatitis B surface antigen (HBsAg) was tested in the third stage of pregnancy for all pregnant women in 1995 to 1998 in two hospitals. The HBsAg positive mothers were tested again before labor. Infants born to the mothers who were classified as HBsAg positive at two occasions were enrolled to receive HBvac alone at 0, 1, 6 mon of age or hepatitis B immunoglobulin (HBIG) immediately at birth and two weeks, then HBvac at 1, 2, 7 mon of age. Totally 117 infants received pHBvac 30 μg each time, 99 received rHBvac 5 μg each time. For infants who received HBvac alone, serum HBsAg and anti HBs were detected before every injection and at 3, 12 mon of age; For infants who received HBIG plus HBvac, serum HBV markers were detected at 1, 4, 7, 12 mon of age. Chronic HBV infection was defined as serum HBsAg positive for more than 6 months and positive at 12 mon of age. Results At 1, 3, 6 and 12 months of age, the serum anti HBs became detectable in 11.3%, 41.2%, 62.7%, 80.9% of subjects who received pHBvac alone, in 8.2%, 41.7%, 58.3%, 77.3% of subjects who received rHBvac alone. Anti HBs was detectable in 67.2%, 69.4%, 85.0%, 87.3% of subjects in HBIG plus pHBvac group and in 70.7%, 53.1%, 50.0%, 89.1% of subjects in HBIG plus rHBvac group. Chronic HBV infection was found in 9.1% of subjects in rHBvac alone group, 10.6% of pHBvac alone group, 6.5% of HBIG plus rHBvac group and 5.5% of HBIG plus pHBvac group. Besides the difference of anti HBs positivity at 7 mon of age between HBIG added subjects(χ 2=15.39, P < 0.005), there were no statistically significant differences between rHBvac and pHBvac group. No severe adverse events were reported in any of the vaccine recipients. Conclusions The homemade rHBvac was safe and 5 μg rHBvac was as effective as 30 μg pHBvac for interruption of the mother to infant HBV transmission.
出处
《中华儿科杂志》
CAS
CSCD
北大核心
2000年第11期682-684,共3页
Chinese Journal of Pediatrics
基金
卫生部临床重点学科建设项目! (970 30 2 2 3)
关键词
疫苗
合成
肝炎病毒
乙型
疾病传播
垂直
Vaccines,synthetic
Hepatitis B virus
Disease transmission,vertical
