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按0、1、6免疫程序,肌肉注射不同剂量(5、10、20μg)国产乙肝血源疫苗,观察其对HBV血清标志均阴性的152名健康学龄儿童的免疫效果。首针后2年,5、10,20μg各组的Anti—HBs应答半分别为88.9％、97.2％、87.2％;Anti—HBs GMT维持在85.7～1052S/N(166.1～322.1mIU/ml);Anti—HBsS/N≥10者三组分别占88.9％、91.7％、84.6％。疫苗组及对照组HBV感染率各为1.74％和32.4％,保护率是94.6％。疫苗接种者无严重不良反应。表明国产乙肝血源疫苗免疫效果确实,低剂量(5μg)用於健度儿童阻断水平传播是可行的。
According to 0, 1, 6 immunization programs, different doses of domestic hepatitis B vaccine were injected intramuscularly to observe the immune effects of 152 healthy school-age children whose HBV seropositive markers were negative. The anti-HBs response in each group was 88.9%, 97.2% and 87.2% respectively at 2 and 5 months after the first injection, while the GMT of Anti-HBs was maintained between 85.7 and 1052S / N (166.1 and 322.1mIU / ml) Anti-HBsS / N≥10 three groups accounted for 88.9%, 91.7%, 84.6%. The HBV infection rates in vaccine group and control group were 1.74% and 32.4% respectively, and the protection rate was 94.6%. Vaccinated persons without serious adverse reactions. The results showed that the immunogenicity of domestic Hepatitis B vaccine was indeed low. It was feasible to use low dose (5μg) for blocking the horizontal transmission of healthy children.