Protective efficacy, immunotherapeutic potential, and safety of hepatitis B vaccines

J Med Virol. 2006 Feb;78(2):169-77. doi: 10.1002/jmv.20524.


Hepatitis B vaccines are highly effective and safe and have been incorporated into national immunization programs in over 150 countries. The major humoral immune response is to the common a determinant of the surface antigen protein of the virus. Approximately 5-10% of healthy immunocompetent subjects do not mount an antibody response (anti-HBs). Non-response is associated with different HLA-DR alleles and impaired Th cell response, among other factors such as route of injection, age, gender, body mass, and other factors. Important hepatitis B surface antigen variants have also been identified, which may have a potential impact on immunization and routine screening of blood, blood products and tissues, and organs for transplantation. Strategies for hepatitis B immunization are reviewed. Over 1,000 million doses of hepatitis B vaccine have been used with an outstanding record of safety. There is no evidence of an association between hepatitis B vaccines and the sudden infant death syndrome, chronic fatigue syndrome, and multiple sclerosis (MS). Several studies are in progress on treatment of chronic hepatitis B infection by immunization with multiple antigenic components, combination of vaccine with antiviral drugs and cytokines, T cell vaccines, DNA vaccines alone or with DNA encoded immunomodulatory cytokines, and direct genetic manipulation of antigen presenting cells.

Publication types

  • Review

MeSH terms

  • Age Factors
  • Alleles
  • HLA-DR Antigens / genetics
  • Hepatitis B / immunology
  • Hepatitis B / prevention & control*
  • Hepatitis B Antibodies / blood
  • Hepatitis B Surface Antigens
  • Hepatitis B Vaccines* / administration & dosage
  • Hepatitis B Vaccines* / genetics
  • Hepatitis B Vaccines* / immunology
  • Hepatitis B Vaccines* / therapeutic use
  • Hepatitis B, Chronic / therapy*
  • Humans
  • Injections
  • Mutation
  • Safety
  • Sex Factors
  • T-Lymphocytes, Helper-Inducer / immunology
  • Vaccination*
  • Vaccines, DNA


  • HLA-DR Antigens
  • Hepatitis B Antibodies
  • Hepatitis B Surface Antigens
  • Hepatitis B Vaccines
  • Vaccines, DNA