国产甲乙型肝炎联合疫苗的安全性和免疫原性初步研究

Evaluation on safety and immunogennicity of a combined hepatitis A and B vaccine in children and young adults.

目的评价国产甲、乙肝联合疫苗的安全性和免疫原性。方法对278名健康儿童和312名健康成人接种国产甲、乙肝联合疫苗 ,并与单价甲肝灭活疫苗和乙肝灭活疫苗进行对照 ,观察其免疫后的副反应和检测抗体阳转率。结果接种国产甲、乙肝联合疫苗成人和儿童中均未观察到严重全身反应和局部反应。首针免疫后7个月 ,儿童组甲肝抗体和乙肝抗体阳转率分别达到100 %和96.88% ,GMT达到29144mIU/ml和102mIU/ml;成人组甲肝抗体和乙肝抗体阳转率也达到100 %和98.84% ,GMT达到21891mIU/ml和112mIU/ml。儿童和成人接种甲乙肝联合疫苗后 ,甲肝和乙肝抗体阳转率和GMT均高于单价疫苗。结论国产甲、乙型肝炎联合疫苗是安全的 ,并可诱导较高的甲肝抗体和乙肝抗体应答。

Objective To evaluate the safety and immunogennicity of a combined hepatitis A and B vaccine,manufactured by Tangshan Yuan Biological Products Co.,Ltd,.Methods137healthy children and127young adults with HbsAg,anti-HBs,anti-HBc and anti-HAV negative selected from Tianyang county of Guangxi Zhuang Autonomous Region were randomly divided into6groups.127children(group AB)and137young adults(group AB)were received5μg/0.5ml and10μg/1.0ml of a home-made combined hepatitis A and B vaccine,respectively,and55children(group B)and55young adults(group B)were received5μg/0.5ml and10μg/1.0ml of hepatitis B vaccine(Beijing Tiantan Biological Products Co.,Ltd,)by0,1,6months schedule,reˉspectively.86children(group A)and137young adults(group A)were received250μ/0.5ml and500μ/1.0ml of inactivated hepatitis A vaccine(Tangshan Yuan Biological Products Co.,Ltd,)by0,6months schedule,reˉspectively The local and systemic side-effects were recorded in the first72hours after each vaccination,and the seroconversion of anti-HAV IgG and anti-HBs were tested at months2and7after the first vaccination.Results The local and systemic side-effects were not observed in all participants within72hours after the first dose of vaccination.Seven months after the first dose of vaccination,the seroconversion rates and GMTs of anti-HAV IgG and anti-HBs were100%,96.8%and29144mIU/mland102mIU/ml in children AB group and100%,98.8%and21891mIU/ml and12mIU/ml in adults AB group,respectively.The seroconversion rates and GMTs of anˉti-HAV IgG and anti-HBs of combined hepatitis A and B vaccine were significantly higher than those of single hepatitis A and hepatitis B vaccines.Conclusion The home-made combined hepatitis A and B vaccine is safe and highly immunogenicity in children and young adults.