Abstract
The hepatitis B vaccine recently licensed for use in the United States has undergone several field trials in high-risk populations and has proven to be immunogenic, efficient and safe. The hepatitis vaccine is unique in that the hepatitis B virus (HBV), the ultimate source of the vaccine, cannot be grown in tissue culture. The immunizing antigen, purified from plasma of healthy human carriers of HBV, consists of noninfectious 22 nm particles of hepatitis B surface antigen (HBsAg), produced as excess viral surface protein and released in the bloodstream. Although the HBsAg particles are highly purified and inactivated, there is some concern that the vaccine may contain traces of host material or infective adventitious agents, which may trigger undesirable effects in the recipients. Ideally, a hepatitis B vaccine candidate should have the following properties: 1) be free of normal human serum protein contaminants, 2) be free of potential residual infectious HBV, 3) be free of other viruses and nucleic acid, 4) have a high degree of immunogenicity when administered in conjunction with an adjuvant suitable for use in humans, 5) be independent of human HBV carriers as a source of immunogenic material, 6) have a reproducible composition, 7) cost less than the present vaccine, and 8) be available in unlimited supplies.
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