重组(酵母)乙型肝炎疫苗对成人36个月的免疫效果及安全性研究

Safety and Immunogenicity of Recombinant Yeast-derived Hepatitis B Vaccine (YDV) on Adults after Three Years of Injection

为探讨重组 (酵母 )乙型肝炎 (乙肝 )疫苗对成人的免疫效果及安全性 ,在辽宁省北票市部分学校选择一般健康状况良好 ,乙肝病毒表面抗原 (HBsAg)与抗体 (抗 HBs)、乙肝病毒核心抗体 (抗 HBc)三项指标均为阴性 ,体温正常 ,2 2～ 5 8岁的教师 12 4名 ,按 0、1、6个月免疫程序 ,接种北京生物制品研究所生产的重组 (酵母 )乙肝疫苗 ,每剂5 μg/ 0 5ml。结果显示 :免疫后 3、7、12、2 4、36个月时 ,抗 HBs阳转率分别为 35 0 %、83 3%、6 9 6 %、32 7%、2 0 8% ,差异有非常显著的统计学意义 (χ2 =117 6 9,P <0 0 1) ;抗 HBs几何平均滴度 (GMT)分别为 12 6 3mIU/ml、4 0 2 0 4mIU/ml、70 2 8mIU/ml、2 0 2 8mIU/ml、12 0 7mIU/ml,差异有非常显著的统计学意义 (F =5 71,P <0 0 1) ;抗 HBs阳转率及GMT均在免疫后 7个月时达到高峰 ,以后又急剧下降 ;免疫后各月女性抗 HBs阳转率和GMT均高于男性 ,但抗 HBsGMT仅在免疫后 3个月时二者之间的差异有非常显著的统计学意义 (t=3 0 0 ,P <0 0 1) ;<35岁组的抗体阳转率高于≥ 35岁组 ,但仅在免疫后 12个月时二者之间的差异有非常显著的统计学意义(χ2 =7 2 5 ,P <0 0 1) ;该两个年龄组间的抗 HBsGMT差异无显著的统计学意义 (P >

To study the safety and immunogenicity of recombinant yeast-derived hepatitis B vaccine (YDV) on adults, 124 healthy teachers of 22～58 years old were randomly selected from Beipiao City of Liaoning Province. Their HBsAg, anti-HBs and anti-HBc were all negative and the body temperature was normal. They were vaccinated with 5μg/0.5ml of YDV, which was made by Beijing Institute of Biological Products, at 0? 1? 6 months. The results showed that the positive seroconversion rates of anti-HBs were 35.0%, 83.3%, 69.6%, 32.7%, 20.8% (χ 2=117.69, P<0.01), the mean geometric titres (GMTs) of anti-HBs were 12.63mIU/ml, 402.04mIU/ml, 70.28mIU/ml, 20.28mIU/ml and 12.07mIU/ml (F=5.71, P<0.01) after 3, 7, 12, 24 and 36 months of vaccination respectively. The anti-HBs positive seroconversion rates and GMT became the highest at 7th month, then began to decrease sharply. At each period, the positive seroconversion rates of anti-HBs and GMT were always higher in female than in male, but GMT of anti-HBs was significantly different only at 3th month post inoculation (t=3.00, P<0.01). The positive seroconversion rates of anti-HBs in <35 year old group was higher than group of ≥35 years old, but it was signficantly different only at 12th month (χ 2=7.25, P<0.01). GMT of anti-HBs between these two groups had no obvious difference. Local or systemic reactions were not found in all the subjects within 3 days after injection. YDV is effective and safe to adults. The duration of persistence of anti-HBs in adults was short as compared to children.