One-year vaccination against hepatitis B virus with a MPL-vaccine in liver transplant patients for HBV-related cirrhosis

Abstract

Conflicting results have been reported on vaccination against hepatitis B virus (HBV) as a prophylaxis against viral recurrence after liver transplantation. We investigated the efficacy of 1-year, monthly vaccination using an adjuvant 3-deacylated monophosphoryl-lipid-A (MPL) recombinant S vaccine initially administered together with hepatitis B immunoglobulins (HBIg) in 18 patients transplanted for HBV-related cirrhosis. All received 12 vaccine doses (HBsAg, 20 mcg plus MPL, 50 mcg): the initial six doses (phase I) were administered within 7days after intravenous HBIg (2000IU), while the last 6 (phase II) following HBIg withdrawal. All patients received lamivudine during the study. Anti-HBs titers were determined before each dose and then for 1year after vaccination. After phase I anti-HBs titers were greater than 100IU/l in all patients and in three (16.6%) were greater than 500IU/l. After phase II 10 patients (55.5%) achieved anti-HBs titers greater than 100IU/l and five (27.7%) greater than 500IU/l. One year after vaccination eight patients (44.4%) maintained anti-HBs titers greater than 100IU/l, with a median titer of 234IU/l (102-1205), and 2 (11.1%) greater than 500IU/l. One-year extended monthly vaccination with a MPL-adjuvant recombinant vaccine induces a sustained protective anti-HBs response in approximately half of transplant recipients

The detection of (total and ccc) HBV DNA in liver transplant recipients with hepatitis B vaccine against HBV reinfection

“…[8][9][10][11] Active immunization with standard hepatitis B vaccines in these patients is considered a promising substitute to the current treatment strategy, although the results of this new strategy have been controversial. [12][13][14][15][16][17][18][19][20][21][22] Some studies have reported that responders to hepatitis B vaccination, defined as patients with anti-HBs, should stop taking HBIG and/or antiviral agents. 12,16,17,[20][21][22] However, the safety of discontinuing HBIG and/or antiviral agents in responders remains unclear.…”

“…[12][13][14][15][16][17][18][19][20][21][22] Some studies have reported that responders to hepatitis B vaccination, defined as patients with anti-HBs, should stop taking HBIG and/or antiviral agents. 12,16,17,[20][21][22] However, the safety of discontinuing HBIG and/or antiviral agents in responders remains unclear. In the present study, we investigated intrahepatic and extrahepatic HBV total DNA and ccc DNA in responders to active hepatitis B immune reconstitution who had discontinued HBIG and/or antiviral agents and in non-responders to active hepatitis B immune reconstitution.…”

Prevention of Post-transplant HBV

“…Studies of hepatitis B vaccination as an alternative to longterm HBIG in LT recipients were conducted in patients at low risk of HBV recurrence [70][71][72][73][74][75][76][77][78][79]. Anti-HBs titers achieved with the vaccination are highly variable and seem in part dependant on the type of vaccine: booster doses, double-dose third-generation recombinant vaccines, and addition of an adjuvant.…”

Hepatitis B and Liver Transplantation: Update in Management before and after Transplantation

“…In a recent trial by Di Paolo et al [34], 18 patients who underwent LT for HBV-related cirrhosis were prospectively given monthly HBV vaccine including a 3-deacylated monophosphoryl-lipid-A adjuvant for 1 year, in addition to standard of care IV HBIG and LAM. After 6 months, patients then underwent the second phase of the study protocol by having HBIG prophylaxis withdrawn.…”