ABSTRACT
Objective] To assess the safety and immunogenicity of booster vaccination 10 μg of recombinant Hansenula hepatitis B vaccine in school-age children , and to provide scientific basis for the development of hepatitis B immunization strategies . [ Methods] A total of 2 101 children were selected as the safety study object and were inoculated with three injections of 10 μg Hansenula hepatitis B vaccine for observation of the incidence of abnormal reaction .Among them 404 schoolchildren were observed for immune effects.And comparison was made in the difference of antibody titers and antibody positive rate before and after immunization . [ Results] Of the 2 101 children, 85 cases of adverse reactions occurred and the incidence rate was 4.05%.Of the 85 cases, 84 had slight reactions , one with moderate reactions and none with severe reactions .After vaccination , the positive rate of protective antibodies increased to 100.00%, and antibody titers rose from 2.55 IU/L to 5 051.90 IU/L, the difference being statistically significant (Z =12.51, P =0.00). [Conclusion] Hansenula hepatitis B vaccine used for booster immunization in schoolchildren is of good security and fine immune effect .