重组乙型肝炎疫苗阻断乙型肝炎病毒母婴传播方案的保护效果评价

目的 评价国产重组乙型肝炎(乙肝)疫苗及其与中效价乙肝免疫球蛋白(HBIG)联合应用母婴阻断方案的保护效果。方法 在广西等3个地区，对乙肝病毒双阳性母亲新生儿，应用重组乙肝疫苗和重组乙肝疫苗加50IU HBIG两种母婴阻断方案免疫新生儿，共随访单纯重组乙肝疫苗母婴阻断儿289例，重组乙肝疫苗加HBIG阻断儿186例。结果 单纯重组乙肝疫苗的母婴阻断效果为87．8％(95％CI：83．6—91．9)，重组乙肝疫苗加HBIG的阻断效果为91．2％(95％CI：86．7—95．6)，重组(酵母)乙肝疫苗和重组(CHO细胞)乙肝疫苗间(P=0．7072)、两种母婴阻断方案间(P=0．2955)及各地免疫人群间(P=0．9987)的母婴阻断效果差异均无显著统计学意义。两种母婴阻断方案免疫新生儿间抗—HBs的阳转率(P＝0．3188)和抗体滴度(GMT)间(P＝0．8925)差异均无显著统计学意义，首剂免疫后1年，抗—HBs阳性率在单纯重组乙肝疫苗组和重组乙肝疫苗加HBIG组分别为91．1％和93．5％，GMT分别为153mIU／ml和164mIU／ml，以后逐年显著下降(线性趋势检验χ^2＝60．47，P=0．0001)，至免疫后第4年，阳性率分别降为65．0％和66．6％，GMT仅为第一年的1／3。结论 重组乙肝疫苗加中效价HBIG的母婴阻断效果可达90％以上，明显优于常规剂量的血源疫苗。中国现行重组乙肝疫苗抗—HBs的免疫检测技术方法有待改进。

Efficacy of recombinant hepatitis B vaccine and low-dose hepatitis B immune globulin in preventing mother-infant transmission of hepatitis B virus infection

OBJECTIVE: To determine the efficacy of recombinant hepatitis B (rHB) vaccine and low-dose hepatitis B immune globulin (HBIG) in the prevention of mother-infant transmission of hepatitis B virus (HBV) infection. METHODS: rHB vaccine was administered to two groups of healthy neonates born to mothers with both hepatitis B surface antigen and e antigen positive in Guangxi, Hunan and Hebei province. Two hundred eighty-nine subjects were included in active immunization group, receiving triple doses of rHB vaccine given i.m. at 0, 1 and 6 month intervals; while 186 subjects receiving 50 IU HBIG at birth with triple doses of rHB vaccine in the low-dose HBIG group. RESULTS: Efficacy of active immunization alone was 87.8% (95% CI: 83.6 - 91.9). Efficacy of rHB vaccine and HBIG was 91.2% (95% CI: 86.7 - 95.6). No significant differences in efficacy by type of rHB vaccine (P = 0.707 2), immunoprophylaxis programs (P = 0.295 5) and regions of living (P = 0.998 7) were noticed. Seroprotection rates (anti-HBs >or= 10 mIU/ml) were detected in 91.1% and 93.5% in rHB vaccine alone recipients and rHB vaccine plus HBIG recipients, with geometric mean titer (GMT) of 153 mIU/ml and 164 mIU/ml at 1 year of age, respectively. Anti-rHBs decreased significantly with years after vaccination (chi(2) = 60.47, P = 0.000 1). Seroprotection rates of anti-rHBs antibodies decreased to 65.0% and 66.6% at 4 years of age in rHB vaccine alone recipients and rHB vaccine plus HBIG recipients, with GMT of 55 mIU/ml and 56 mIU/ml, respectively. CONCLUSION: These results suggested that the effectiveness of rHB vaccine plus low-dose HBIG was much better than only active plasma-derived vaccine; however, methods used for anti-rHBs assay need to be evaluated and verified.