title: Immunogenicity and safety of an investigational AS02(v)-adjuvanted hepatitis B vaccine in patients with renal insufficiency who failed to respond or to maintain antibody levels after prior vaccination: results of two open, randomized, comparative trials.
abstract: An investigational AS02(v)-adjuvanted hepatitis B (HB-AS02) was compared with a licensed conventional recombinant hepatitis B vaccine (HBVAXPRO™; Sanofi Pasteur MSD, Lyon, France) in pre-dialysis, peritoneal dialysis and hemodialysis patients aged ≥18 years who had failed either to respond to prior vaccination with a conventional hepatitis B vaccine (Study A; n=251) or to maintain protective antibody concentrations after prior hepatitis B vaccination (Study B; n=181). These were open, randomized, comparative trials. Mean (range) age was 65.9 (31-92) and 64.6 (29-92) years in the two studies, respectively. In Study A, two doses of HB-AS02 given one month apart were found to be superior to two doses of the licensed vaccine in terms of seroprotection rate (76.9% versus 37.6%) and anti-HBs geometric mean antibody concentration (GMC; 139.3 versus 6.9mIU/ml), with antibody concentrations ≥100mIU/ml in 61.1% and 15.4% of subjects in the two groups, respectively. In Study B, one month after administration of a single booster dose, seroprotection rates were 89.0% in the HB-AS02 group and 90.8% in the licensed vaccine group, 81.3% and 60.9% of subjects had antibody concentrations ≥100mIU/ml, and anti-HBs GMCs were 1726.8 and 189.5mIU/ml. HB-AS02 was found to be more reactogenic than the licensed vaccine. In summary, the investigational HB-AS02 vaccine induced higher seroprotection rates and anti-HBs GMCs than a licensed conventional hepatitis B vaccine in uremic patients who had failed to respond or to maintain protective antibody titers after prior hepatitis B vaccination.
authors.affiliation: ULB Hôpital Erasme, Département de Néphrologie, Dialyse et Transplantation, Bruxelles, Belgium.
authors.forename: Christian L
authors.initials: CL
authors.lastname: Tielemans
authors.forename: Jiri
authors.initials: J
authors.lastname: Vlasak
authors.forename: Dezider
authors.initials: D
authors.lastname: Kosa
authors.forename: Jean-Marie
authors.initials: JM
authors.lastname: Billiouw
authors.forename: Gert A
authors.initials: GA
authors.lastname: Verpooten
authors.forename: Ilona
authors.initials: I
authors.lastname: Mezei
authors.forename: Miroslav
authors.initials: M
authors.lastname: Ryba
authors.forename: Patrick C
authors.initials: PC
authors.lastname: Peeters
authors.forename: Olivier
authors.initials: O
authors.lastname: Mat
authors.forename: Michel Y
authors.initials: MY
authors.lastname: Jadoul
authors.forename: Vladimir
authors.initials: V
authors.lastname: Polakovic
authors.forename: Michel
authors.initials: M
authors.lastname: Dhaene
authors.forename: Serge
authors.initials: S
authors.lastname: Treille
authors.forename: Sherine O
authors.initials: SO
authors.lastname: Kuriyakose
authors.forename: Maarten
authors.initials: M
authors.lastname: Leyssen
authors.forename: Sophie A
authors.initials: SA
authors.lastname: Houard
authors.forename: Murielle
authors.initials: M
authors.lastname: Surquin
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000818:Animals; D000914:Antibodies, Viral / Q000097:blood*; D004338:Drug Combinations; D005260:Female; D005602:France; D017325:Hepatitis B Vaccines / Q000009:adverse effects* / Q000276:immunology*; D006801:Humans; D007117:Immunization, Secondary / Q000379:methods; D008050:Lipid A / Q000008:administration & dosage / Q000031:analogs & derivatives*; D008297:Male; D008875:Middle Aged; D006435:Renal Dialysis; D051437:Renal Insufficiency / Q000276:immunology* / Q000628:therapy; D012503:Saponins / Q000008:administration & dosage*; D014611:Vaccination / Q000379:methods*
chemical_list: C501939:ASO2A adjuvant; D000914:Antibodies, Viral; D004338:Drug Combinations; D017325:Hepatitis B Vaccines; D008050:Lipid A; D012503:Saponins