一种新型重组(汉逊酵母)乙型肝炎疫苗人体安全性和免疫效果考核

Evaluation on Safety and Immunization Effectivity of a New Recombinant(Hansenula Polymorpha)Hepatitis B Vaccine on Human

为了观察一种新型重组 (汉逊酵母 )乙型肝炎 (乙肝 )疫苗的人体安全性、抗体应答和母婴传播阻断效果 ,在开封市筛选 6～ 9岁乙肝病毒 (HBV)感染指标 [乙肝病毒表面抗原 (HBsAg)与抗体 (抗 HBs)、乙肝病毒核心抗体 (抗 HBc) ]均阴性的健康儿童 2 0名 ,按 0、1、6个月程序接种 1批重组 (汉逊酵母 )乙肝疫苗 ,观察不良反应。完成 3针免疫观察未见严重不良反应后 ,选择 348名 6～ 9岁HBV感染指标阴性儿童 ,随机分为 3组 ,每组接种 1批重组 (汉逊酵母 )乙肝疫苗 ,进一步观察不良反应和抗体应答。筛选 4 5名怀孕期间HBsAg、乙肝病毒e抗原 (HBeAg)双阳性母亲所生的新生儿作为研究对象 ,并以 4 1名怀孕期间HBsAg阴性母亲所生的新生儿和 5名母亲HBsAg阳性、HBeAg阴性的新生儿作为对照 ,按 0、1、6个月免疫程序接种该乙肝疫苗。结果显示 :所有接种的儿童和新生儿 ,免疫后无 1人发现有严重不良反应。 348名接种乙肝疫苗的儿童中 ,除 5人次发热反应在 38 1℃～ 38 5℃外 ,体温升高均≤ 38℃。所有发热反应者和个别头痛者均在 1d内恢复正常。儿童接种 3批疫苗 ,第 1针免疫后 7个月时抗体阳转率分别为 98 2 5 % ( 112 / 114 )、10 0 0 0 % ( 10 7/ 10 7)、99 2 1% ( 12 6 / 12 7) ;抗体几何平均滴度 (GMT)分别为35

To assess the safety,antibody response and the interruption of mother-infant transmission of a new recombinant(Hansenule Polymorpha)hepatitis B vaccine(HP) 20 healthy children aged 6～9 years old whose HBV infectious markers(HBsAg,anti-HBs and anti-HBc)were negative were chosen and vaccinated HP vaccine following 0,1,6 months schedule,adverse effect was observed after each dose After full dose vaccination no severe adverse effect occurred,then 348 healthy children aged 6～9 years were randomly divided to 3 groups,each group received one lot of HP vaccines to further observe the adverse effect and antibody response. 45 infants of HBsAg and HBeAg positive mothers were chosen as study group,5 infants of HBsAg positive and HBeAg negative mothers and 41 infants of HBsAg and HBeAg negative mothers were selected as control groups to be vaccinated HP following the same schedule The results showed no serious adverse effects were found. Among all 348 vaccinated children the temperatures of all children were below 38℃ except 5 persontimes were at 38 1℃-38 5℃,and all the cases with fever and headache recovered within 24 hours 7 months after the first dose (T7), antibody convertion rates among 3 groups were 98 25%(112/114),100%(107/107)and 99 21%(126/127)respectively The geometric mean titers(GMT) were 3513 56mIU/ml,19197 27mIU/ml and 4536 08mIU/ml respectively The antibody titer decreased slightly 12 months after the first dose vaccination Among the 45 infants whose mothers were HBsAg and HBeAg positive,2 cases were detected HBsAg positive 7 months after the first dose immunization,the antibody positive rate was 4 44%,and the protection rate interrupting the mother-infant transmission was 95 07% Among the 41 infants whose mothers were healthy and 5 infants whose mothers were HBsAg positive,no case was detected HBsAg positive 7 months after the first dose vaccination This result suggests the new recombinant hepatitis B vaccine is safe and can induce high level antibody response and interrupt the mother-infant transmission effectively after vaccination The effect is related to the strong inducement of cellular immunogenicity