Safety and immunogenicity of a recombinant hepatitis B vaccine

Publisher Website
Google Scholar
Abstract
A hepatitis B vaccine produced in yeast by recombinant DNA technology was evaluated using 5‐μg and 10‐μg doses in a randomized trial lasting 7 months in 110 male armed forces recruits aged 17–19 years. Results were compared to those of an identical trial of a plasma‐derived vaccine. No allergic reactions were observed, and the rate of mild side effects was similar to the plasma‐derived vaccine. Seroconversion rates in the first month were 60% (33/55) and 67% (37/55) with the 5‐μg and 10‐μg doses of the recombinant vaccine, respectively. All participants seroconverted by 3 months, and none lost antibody. These results are very similar to those for plasma‐derived vaccine. Comparison of titres of antibody to hepatitis B surface antigen (anti‐HBs) showed a slightly higher level with the 10‐μg than with the 5‐μg dose of the recombinant vaccine. Geometric mean titres of anti‐HBs after the booster dose were similar in the 5‐μg and 10‐μg dose recombinant vaccine groups (2,620 and 2,748 IU/I, respectively) and in the 5‐μg plasma‐derived vaccine group (3,591 IU/I) but significantly higher (9,227 IU/I) with the 10‐μg dose of the plasma‐derived vaccine. These results confirm the safety and immunogenicity of the recombinant vaccine, although further study is needed on the duration of immunity.