title: Recombinant Hepatitis B Vaccine Adjuvanted With AS04 in Dialysis Patients: A Prospective Cohort Study.
abstract: OBJECTIVE
  Patients undergoing maintenance dialysis have an unsatisfactory response to vaccination, including to hepatitis B vaccine. A recombinant HB vaccine containing a new adjuvant system AS04 (HBV-AS04) has been recently developed; a few data exist on the immunogenicity and safety of HBV-AS04 among patients undergoing regular dialysis. All hepatitis B virus-seronegative patients with undetectable antibody against HBsAg undergoing maintenance dialysis at two units were prospectively included.
  
  
  METHODS
  Patients received four 20-mcg doses of HBV-AS04 by intramuscular route (deltoid muscle) at months 0,1,2, and 3. Anti-HB surface antibody concentrations were measured at intervals of 1, 2, 3, 4, and 12 months. Univariate and multivariate analyses determined which parameters predicted immunologic response to HBV-AS04 vaccine.
  
  
  RESULTS
  102 patients were enrolled and 91 completed the study. At completion of the vaccination schedule, using per-protocol analysis, 76 of 91 (84%) had antibody titers ≥10 mIU/mL with anti-HBs geometric antibody concentrations (GMCs) of 385.25 mIU/mL. The sero-protection rate at month 12 was 84% (48/57) with lower GMCs (62.74 mIU/mL, P<0.0001). Multivariate analysis revealed a detrimental role of age on the immune response to HB-AS04 vaccine (F Ratio, 4.04; P<0.04). Tolerance to HBV-AS04 was good and only minor side-effects were observed.
  
  
  CONCLUSIONS
  HBV-AS04 vaccine was highly immunogenic in our cohort of patients on maintenance dialysis even if a significant number of non-responders is still present. Prospective studies with HBV-AS04 on larger study groups and with longer follow-ups are under way.
authors.affiliation: Division of Nephrology, Maggiore Hospital and IRCCS Foundation, Milano, Italy.
authors.forename: Fabrizio
authors.initials: F
authors.lastname: Fabrizi
authors.forename: Antonio
authors.initials: A
authors.lastname: Tarantino
authors.forename: Claudia
authors.initials: C
authors.lastname: Castelnovo
authors.forename: Paul
authors.initials: P
authors.lastname: Martin
authors.forename: PierGiorgio
authors.initials: P
authors.lastname: Messa
mesh_terms: D000276:Adjuvants, Immunologic; D000328:Adult; D000368:Aged; D000375:Aging / Q000276:immunology; D015331:Cohort Studies; D005260:Female; D006514:Hepatitis B Surface Antigens / Q000097:blood; D017325:Hepatitis B Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology*; D006801:Humans; D007115:Immunization Schedule; D007273:Injections, Intramuscular; D008050:Lipid A / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000276:immunology; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D006435:Renal Dialysis; D012449:Safety; D014614:Vaccines, Synthetic
chemical_list: D000276:Adjuvants, Immunologic; D006514:Hepatitis B Surface Antigens; D017325:Hepatitis B Vaccines; D008050:Lipid A; D014614:Vaccines, Synthetic; C530461:hepatitis B vaccine AS04