Active hepatitis B immunization with an experimental German vaccine. I. Immunogenicity studies in healthy adults. II. The primary 19 S and 7 S responses to HBsAg in healthy adults. III. Immunogenicity studies in hemodialysis patients.

The immunogenicity of an experimental german hepatitis B vaccine has been evaluated in 343 healthy adults. Three doses of vaccine induced anti-HBs antibodies in 94 to 100% of the vaccines. Different batches and doses of vaccine did not significantly influence the seroconversion rates at the end of the vaccine trial. Higher doses were followed by more rapidly and more vigorously occurring anti-HBs-levels. Significant differences were noticed between the 40 micrograms- und the 10- or 8 micrograms-doses. Variation of schedules (0-1-6 or 0-1-5) did not result in significant differences. Batch-no. I/B 070881 induced significant lower anti-HBs levels than batch-no. II/310781. Females developed significant higher anti-HBs values than males, younger vaccinees higher than older vaccinees. Rate zonal ultracentrifugation analysis of anti-HBs-positive sera collected after vaccination regularly revealed anti-HBs of the IgM class in case of early and high immune response to the vaccine. Individuals characterized by a late onset of anti-HBs production developed anti-HBs antibodies of the IgG class only. The vaccine induced an anti-HBs response in 64 to 75% of hemodialysis patients. The conversion rates and the achieved anti-HBs levels were significantly higher in young and/or female patients than in old and/or male patients.