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.
D000293:Adolescent; D000328:Adult; D000368:Aged; D006510:Hepatitis B Antibodies / Q000032:analysis; D017325:Hepatitis B Vaccines; D006358:Hot Temperature; D006801:Humans; D008875:Middle Aged; D006435:Renal Dialysis; D012306:Risk; D014611:Vaccination; D014765:Viral Vaccines / Q000009:adverse effects / Q000276:immunology*
D006510:Hepatitis B Antibodies; D017325:Hepatitis B Vaccines; D014765:Viral Vaccines