Background : In order to evaluate the immunogenicity and safety of recombinant DNA yeast derived hepatitis B vaccine(Euvax-B) among healthy adults a clinical trial was conducted.
Methods : 70 healthy adults(male 58, female 12) were included from August 1993 to June 1994. 40 cases were given 1.0ml of yeast derived vaccine(Euvax-B) intramuscularly in the deltoid muscle at 0, 1, 6 months and 30 controls were given 1.0ml of plasma derived vaccine(Hepavax-B) by same method. Anti-HBs antibody was tested at 1, 2, 6, 7 months after first vaccination by radioimmunoassay(Abbott).
Results : After three injections the seroconversion rate of case group(97.1%) was similar to that of control group(100.0%). Geometric mean titers were 302 RIA units(95% CI 179-526) in case group and 631 RIA units(95% CI 322-1,277) in control group. Adverse events were fatigue(2.5%), myalgia(2.5%), fever(1.3%), pain in injection site(1.3%) in case group and myalgia(8.6%), dizziness(1.7%) in control group.
Conclusion : Immunogenicity of recombinant DNA yeast derived hepatitis B vannice(Euvax-B) among adults is comparable to that to plasma derived by 0, 1, 6 month schedule.