Surveillance of the immunogenicity of a 20 μg/dose of hepatitis B vaccine made by recombinant deoxyribonucleic acid techniques in Saccharomyces cerevisiae (Hep B-SCY) in people aged 16 years and above

Abstract

Objective To evaluate the immunogenicity of a 20 μg/dose of hepatitis B vaccine made by recombinant deoxyribonucleic acid techniques in Saccharomyces cerevisiae (Hep B-SCY) in post-marketing stage among people aged 16 years and above. Methods This study recruited 4 636 healthy subjects aged 16 years and above, who were negative for hepatitis B surface antigen (HBsAg) and the antibodies to HBsAg (anti-HBs) in them were lower than 100 mIU/ml. The subjects were intramuscularly immunized with 20 μg/dose of Hep B-SCY vaccine on a three-dose schedule (vaccination at months 0, 1 and 6). The levels of anti-HBs were detected by chemiluminescence microparticle immunoassay (CMIA). Results The anti-HBs immune success rates and the geometric mean concentrations (GMCs) in subjects whose pre-immune anti-HBs titers were <100 mIU/ml and ≥10 mIU/ml were respectively 90.24%(703/779), 1 314.35 mIU/ml and 97.82%(449/459), 2 065.96 mIU/ml after 30 to 45 days of vaccination with 1 or 2 doses of the Hep B-SCY vaccine (20 μg/dose). The antibody positive conversion rates, the highly response rates and the GMCs in subjects of pre-immune anti-HBs<10 mIU/ml were respectively 69.16%(74/107), 50.47%(54/107), 47.68 mIU/ml; 86.13%(1 975/2 293), 56.43%(1 294/2 293), 147.94 mIU/ml and 98.72%(1 844/1 868), 87.53%(1 635/1 868), 649.15 mIU/ml after 30 to 45 days of vaccination with 1, 2 or 3 doses of the Hep B-SCY vaccine. Conclusion The post-marketing surveillance indicated that the three-dose schedule (vaccination at months 0, 1 and 6) of Hep B-SCY (20 μg /dose) showed good immunogenicity in healthy people aged 16 years and above. Key words: Recombinant hepatitis B vaccine (Saccharomyces cerevisiae); Healthy people aged 16 years and above; Immunogenicity