Lack of immune potentiation by complexing HBsAg in a heat-inactivated hepatitis B Vaccine with antibody in hepatitis B immunoglobulin

In a randomized, dose-response study among 305 health care workers, we examined whether the immunogenicity of a heat-inactivated hepatitis B vaccine could be enhanced when HBsAg was complexed by anti-HBs contained in hepatitis B immunoglobulin either at equivalent proportions or at 10-fold antigen excess. The dose of HBsAg in the control vaccine as well as in the two complexed vaccine preparations could be reduced from the standard value (3 micrograms) to 0.6 micrograms per injection without affecting the antibody response in the vaccinees. Still lower dosages of HBsAg in the three vaccine preparations induced significantly lower but comparable anti-HBs responses. These results indicate that, in man, using a heat-inactivated plasma vaccine, addition of anti-HBs contained in hepatitis B immunoglobulin does not potentiate the immunogenicity of HBsAg.