Response to an experimental HBV vaccine permits withdrawal of HBIg prophylaxis in fulminant and selected chronic HBV-infected liver graft recipients

Liver Transpl. 2005 Oct;11(10):1228-34. doi: 10.1002/lt.20464.

Abstract

Strategies using lamivudine and hepatitis B immunoglobulins (HBIg) for prevention of hepatitis B virus (HBV) reinfection after liver transplantation (LT) are expensive since life-long treatment is needed. We evaluated the possibility to obtain protective hepatitis B surface antigen (HBsAg) antibody (anti-HBs) titers after LT and to discontinue HBIg prophylaxis after a reinforced course of vaccination against HBV using an experimental adjuvant HBsAg / AS04 vaccine (GlaxoSmithKline Biologicals [GSK], Rixensart, Belgium) in patients transplanted for hepatitis B. Fifteen LT patients on stable low-level immunosuppression were vaccinated with a double dose of the vaccine at 0, 1, 2, 6, and 12 months: 5 patients were transplanted for nonviral diseases and 10 patients were transplanted for HBV on HBIg monotherapy. HBIg were continued during baseline vaccination (0, 1, and 2 months) and when anti-HBs titers determined every 6 weeks dropped below 150 IU/L. Overall follow-up was 18 months. Sustained long-term response to vaccination was defined as anti-HBs titers >500 IU/L without further need for HBIg administration during a follow-up period of at least 12 months. Overall sustained response to vaccination was 53% (8 / 15 patients); 80% (4 / 5 patients) in the nonviral disease group and 40% (4 / 10 patients) in the HBV group (2 /2 fulminant and 2/8 chronically infected patients) developed a sustained long-term response and were completely free of HBIg at the end of the 18-month follow-up. No HBV recurrence, rejection episodes, or side effects occurred during the follow-up. In conclusion, protective anti-HBs titers were obtained in a substantial number of LT patients following a reinforced course of HBV vaccination with vaccines containing new immunostimulating adjuvants. Vaccination seems well tolerated and safe and allows long-term discontinuation of HBIg.

MeSH terms

  • Adult
  • Aged
  • Cadaver
  • Female
  • Hepatitis B / immunology*
  • Hepatitis B / prevention & control
  • Hepatitis B / surgery
  • Hepatitis B Antibodies / blood
  • Hepatitis B Surface Antigens / therapeutic use
  • Hepatitis B Vaccines / therapeutic use*
  • Hepatitis B, Chronic / immunology*
  • Hepatitis B, Chronic / prevention & control
  • Hepatitis B, Chronic / surgery
  • Humans
  • Immunization, Passive*
  • Immunoglobulins / therapeutic use*
  • Liver Transplantation / immunology*
  • Living Donors
  • Male
  • Middle Aged
  • Recombinant Proteins / therapeutic use
  • Tissue Donors
  • Treatment Outcome

Substances

  • Hepatitis B Antibodies
  • Hepatitis B Surface Antigens
  • Hepatitis B Vaccines
  • Immunoglobulins
  • Recombinant Proteins
  • hepatitis B hyperimmune globulin