Immunogenicity and safety of heat-inactivated hepatitis B vaccine (CLB) in low risk human volunteers and in patients treated with chronic haemodialysis in the Netherlands.

The immunogenicity and safety of a heat-inactivated hepatitis B vaccine (HB-vaccine) were studied in healthy human volunteers (n = 471) at a low risk to be infected with hepatitis B virus (HBV) and in patients on chronic haemodialysis (n = 227), who were treated in hepatitis B free centres. After vaccination with 3 injections of 3 micrograms heat-inactivated HBsAg adsorbed to A1PO4, given at monthly intervals, 93% of the healthy low risk volunteers had formed anti-HBs. The haemodialysis patients were randomly divided into 2 groups, which were vaccinated with 3 monthly injections of 3 micrograms and 27 micrograms heat-inactivated HBsAg, respectively. It appeared, that this 9-fold increase of the vaccine-dosage enhanced the anti-HBs response from 77% in the 3 micrograms vaccinees to 94% in the 27 micrograms recipients. Side-effects of the vaccination were negligible, formation of autoantibodies in consequence of the vaccine treatment was not demonstrated in any of the vaccinees.