title: Immunogenicity and safety of an experimental adjuvanted hepatitis B candidate vaccine in liver transplant patients.
abstract: Patients with chronic liver disease are at higher risk of hepatitis B (HB) virus infection before and after liver transplantation, and they commonly have a suboptimal immune response to HB vaccines. In this randomized trial, we compared the immunogenicity of primary vaccination with 2 doses of an experimental adjuvanted HB vaccine (adjuvant system 04 containing aluminium and monophosphoryl lipid A [HB-AS04]) to that of 3 double doses of a licensed HB vaccine in 93 liver transplant candidates. Depending on the waiting list for liver transplantation, a booster dose of HB-AS04 or double booster dose of the licensed HB vaccine was given before or after surgery, at 6 to 12 months after initiation of the vaccination course. The percentage of subjects with seroprotective anti-HB surface antibody concentrations 1 month after booster was twice as high in the HB-AS04 group (60.0%), vs. patients in the comparator group (32.0%) (P = 0.035). In subjects who did not undergo liver transplantation before administration of the booster, better immunogenicity results were obtained: 80% of subjects were seroprotected after HB-AS04 vaccination vs. 60% with the comparator (P = 0.2302). Despite a slightly higher reactogenicity, the safety profile of the HB-AS04 vaccine was clinically acceptable. In conclusion, an improved antibody response was observed in liver transplant candidates with 3 doses of HB-AS04, as compared to 4 double doses of a comparator. Liver transplant candidates could benefit from the use of this experimental adjuvanted HB vaccine to further increase their protection against HB infection.
authors.affiliation: Department of Hepatology, University Hospital Gasthuisberg K.U. Leuven, Leuven, Belgium. frederik.nevens@uz.kuleuven.ac.be
authors.forename: Frederik
authors.initials: F
authors.lastname: Nevens
authors.forename: Jane N
authors.initials: JN
authors.lastname: Zuckerman
authors.forename: Andrew K
authors.initials: AK
authors.lastname: Burroughs
authors.forename: Maria-Christina
authors.initials: MC
authors.lastname: Jung
authors.forename: José M
authors.initials: JM
authors.lastname: Bayas
authors.forename: Birgit
authors.initials: B
authors.lastname: Kallinowski
authors.forename: Enrique Fraga
authors.initials: EF
authors.lastname: Rivas
authors.forename: Christophe
authors.initials: C
authors.lastname: Duvoux
authors.forename: Peter
authors.initials: P
authors.lastname: Neuhaus
authors.forename: Faouzi
authors.initials: F
authors.lastname: Saliba
authors.forename: Maria
authors.initials: M
authors.lastname: Buti
authors.forename: Jean-Pierre
authors.initials: JP
authors.lastname: Zarski
authors.forename: Fernando
authors.initials: F
authors.lastname: Pons
authors.forename: Claire
authors.initials: C
authors.lastname: Vanlemmens
authors.forename: Virginie
authors.initials: V
authors.lastname: Hamtiaux
authors.forename: Michel
authors.initials: M
authors.lastname: Stoffel
mesh_terms: D000276:Adjuvants, Immunologic / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D000328:Adult; D005260:Female; D006509:Hepatitis B / Q000276:immunology / Q000517:prevention & control*; D006510:Hepatitis B Antibodies / Q000096:biosynthesis / Q000097:blood; D017325:Hepatitis B Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology* / Q000627:therapeutic use; D006801:Humans; D007117:Immunization, Secondary; D016031:Liver Transplantation; D008297:Male; D008875:Middle Aged; D013997:Time Factors
chemical_list: D000276:Adjuvants, Immunologic; D006510:Hepatitis B Antibodies; D017325:Hepatitis B Vaccines