Heat-inactivated HBsAg as a vaccine against hepatitis B

Abstract Hepatitis B (HB) vaccine was prepared as follows: hepatitis B surface antigen (HBsAg) was purified from pooled plasma positive for HBsAg (subtype adw2), boiled for 90 s at 101°C and adsorbed to aluminum hydroxide; subsequently, 1 ml doses, containing 0.15 μg HBsAg, were filled off and pasteurized for 10 h at 65°C. Potency studies of the vaccine were done in rabbits, and tests for safety were carried out in three non-immune chimpanzees and four human volunteers. Neither hepatitis (B) nor autoimmune phenomena were observed in any of the vaccinated chimpanzees or humans, whereas all rabbits and chimpanzees and three of the four humans formed anti-HBs antibody.