Abstract：Objective To evaluate the safety of 60 μg recombinant hepatitis B vaccine（Saccharomyces Cerecisiae）in healthy population over 16 years old and immunogenicity in non-responders. Methods A total of 4 345 eligible subjects over 16 years old were selected and vaccinated with 60 μg recombinant hepatitis B vaccine, including 3 415 participants who have never been vaccined before and 930 non-responders. All participants were monitored for any adverse events occurring within 30 min after each injection and instructed to record selected injection-site reactions and systemic reactions on the day of vaccination and the subsequent 28 days. Blood samples were collected from non-responders at pre-vaccination and one month after vaccination,in order to determine anti-HBs levels,positive rates of anti-HBs and the mean geometric titre（GMT）of anti-HBs. Results Among 4 345 vaccinated participants,16.39 % of them reported at least one injection-site or systemic adverse reaction. The most common injection-site and systemic adverse reactions were Grade 1 adverse reactions with the incidence of 15.12 %（657/4 345）and 4.05%（176/4 345）respectively. No serious adverse events were observed. Among 930 non-responders,the positive rate of anti-HBs was 87.03 % with active responder of 76.74 %（551 / 718）and the GMT of anti-HBs was 479.28 mIU / ml. The positive rate of anti-HBs was not associated with gender or age（P>0.05）. The GMT of anti-HBs demonstrated significant differences between female and male （560.66 mIU / mL VS. 404.91 mIU / mL,P<0.05）,but there was no significant differences in different age groups（P>0.05）. Conclusion 60 μg recombinant hepatitis B vaccine was safe for healthy adults above 16 years and had good immunity efficacy among non-responders who had no or low response to standard immunization regimen of hepatitis B vaccine.
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