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

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.