[Detection of pre-S gene products in HBsAg carriers and in hepatitis B vaccines].

The immunogenicity and efficacy of different commercially available vaccines against hepatitis B virus (HBV) has been demonstrated in a number of controlled vaccination trials throughout the world. However, the significance of pre-S proteins in hepatitis B vaccines is still controversially discussed. Therefore, a radioimmunoassay (RIA) was developed to detect pre-S proteins in HBsAg-carriers as well as in different hepatitis B vaccines. This study confirmed the high amount of pre-S proteins as well as poly-albumin receptors in purified Dane particles and sera of patients with acute hepatitis B. The currently available plasma derived vaccine H-B-Vax and the recombinant hepatitis B vaccines Gen H-B-Vax and Engerix B yielded negative results in pre-S- and poly-albumin-receptor-RIAs. The plasma derived vaccine Hevac B Pasteur included pre-S encoded proteins. Future vaccination trials in man have to evaluate the role of pre-S antigens and antibodies in the pathogenesis and the protection of hepatitis B infection including recombinant pre-S vaccines which are under development.