Evaluation on the effect of immunization and safety of live attenuated and inactivated hepatitis A vaccine in China / 中华流行病学杂志

ABSTRACT

Objective To evaluate the safety of both domestic live attenuated and inactivated hepatitis A vaccines,and to provide reference for emergent vaccination after hepatitis A outbreaks.Methods 493 children aged 6-9 with negative antibody to HAV (produced by Abbott) were randomly divided into four groups as vaccinated with domestic live attenuated hepatitis A vaccine (Group A),domestic inactivated hepatitis A vaccine (Group B),imported inactivated hepatitis A vaccine (Group C) and hepatitis B vaccine (Group D) respectively.Adverse events following the immunization were observed 30 minutes,24,48 and 72 hours after the vaccination,under doubleblind method.Results The main AEFIs werefever,local pain and scleroma but no other severe AEFIs were obvserved.The rates of AEFIs were 13.95％ in Group A,15.25％ in group B,16.80％ in group C and 25.62％ in group D,with no statistical differences between these groups (x2=6.953,P＞0.05).2 weeks after the vaccination,the positive conversion rates of domestic live attenuated hepatitis A vaccine and domestic inactivated hepatitis A vaccine were 85.00％ and 94.59％ respectively.The rate of domestic inactivated hepatitis A vaccine reached 100％ at 4 weeks after the vaccination.The antibody levels of HAV-IgG of Group A and B in 2,4 and 12 weeks of vaccination and of Group C were higher than that of Group D.After 12 weeks of vaccination,the antibody level of group B became higher than it was Group C.Conclusion There were no differences on safety among domestic live attenuated hepatitis A vaccine,domestic inactivated hepatitis A vaccine or imported inactivated hepatitis A vaccine under routine or emergency vaccination.All the vaccines showed satisfactory effects.