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Developments leading to the preparation and testing for safety and potency of a highly purified inactivated preparation of hepatitis B surface antigen are descirbed. Protective efficacy studies in chimps of a lot of the inactivated hepatitis B vaccine are currently and suitable for clinical trials in man.
Highly purified hepatitis B virus surface antigen (Australia antigen) purified by physical and chemical procedures from infected human plasma was used to prepare hepatitis B vaccine. The purified antigen was treated with formalin and the vaccine was tested exhaustively for safety by ordinary procedures and additionally in marmosets (for live hepatitis B(More)
Soon after the plasma-derived hepatitis B vaccine became available in the US, the Centers for Disease Control and the manufacturer received over 100 reports of vaccinated groups with unexpectedly low levels of vaccine-induced antibody. To confirm previous retrospective surveys relating these failures to buttock injection and to evaluate the effect of other(More)
A highly purified and inactivated vaccine was made of hepatitis B virus surface antigen. The vaccine was tested exhaustively for safety by ordinary procedures and additionally in chimpanzees and marmosets. It was highly potent and induced antibody in guinea pigs, grivet monkeys, and chimpanzees after three doses of vaccine were given subcutaneously.(More)
A competitive radioimmunoassay was developed for measuring hepatitis B virus (HBV) anti-PreS2 antibody. The assay has been demonstrated to be highly specific for anti-PreS2 antibody and not subject to interference by other antibodies to HBV-specific antigens. This assay was used to evaluate anti-PreS2 antibody responses in a hepatitis B PreS2 + S vaccine(More)