OBJECTIVETo evaluate safety and immunogenicity of inactivated hepatitis A vaccine in HBsAg carriers and healthy children.

METHODSOne hundred and twenty-one healthy children and ten HBsAg carriers, aged 1-10 years HAV susceptible were enrolled in the study. The inactivated hepatitis A vaccine was produced by Tangshan Biogenetic Company. The dosage of the vaccine was 1000 U/Dosage and 500 U/Dosage. The vaccination schedule was six month apart for two injections. The serum anti-HAV level was detected with EIA at one month after first injection and at one and six month after the booster injection, respectively.

RESULTSThe anti-HAV appeared in all the children. One month after the booster injection, the serum anti-HAV level in children vaccinated 500 U/Dosage was 4684.9 mIU and 4535.6 mIU, respectively and in the children vaccinated 1000 U/Dosage, 5399.8 mIU and 7347.1 mIU, respectively. The anti-HAV level was not statistically different between the two groups of children. There was no adverse reaction after the vaccination. The anti-HAV level was still high one year after first injection.

CONCLUSIONSThe data indicated that the safety and immunogenicity of the domestic inactivated hepatitis A vaccine were excellent in both groups of children.