Practical Considerations in Converting from Plasma-Derived to Recombinant Hepatitis B Vaccines

Abstract

Plasma-derived and recombinant vaccines have been developed to prevent hepatitis B virus infections. Both types of vaccine perform very well with respect to safety, immunogenicity and protective efficacy. The protection afforded by both types of vaccine is satisfactory for at least 5 to 10 years after vaccination, and a further booster dose is not necessary during this period. However, the plasma-derived vaccine is costly to produce and there is an unjustified but prevalent fear that it may be contaminated by potential pathogens. The supply of human plasma for production of the plasma-derived vaccine cannot be assured once use of hepatitis B vaccines becomes universal. It is therefore inevitable that the recombinant vaccine will replace the plasma-derived vaccine. If necessary, both vaccines can be used in combination. Future directions for hepatitis B vaccine development include: determination of the need for incorporation of pre-S gene products to enhance immunogenicity; defining a practical strategy to combat the problem of escape mutants after vaccination; and development of combination vaccines containing other inactivated antigens to allow complete immunisation against several diseases with a minimal number of injections.