Abstract

Hepatitis B surface antigen in the form of 22-nm spherical particles (and tubular forms) is excess virus coat protein. Guidelines for the preparation of the 22-nm spherical particles (and their separated polypeptides) derived from the plasma of asymptomatic human carriers were suggested by the WHO Expert Committee on Viral Hepatitis in 1977, and the proposed requirements for the 22-nm hepatitis B particle vaccine were published by the WHO Expert Committee on Biological Standardization in 1981 and revised in 1983. Such preparations have been tested for safety and protective efficacy, and many clinical studies in several million individuals with the plasma-derived vaccine have demonstrated the immunogenicity, high protective efficacy and safety of the currently licensed preparations meeting WHO requirements (Deinhardt and Zuckerman 1985).

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