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

Elsevier Ltd 2011

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.

Adult; Aged; Immunization, Secondary - methods; Lipid A - administration & dosage, analogs & derivatives; Male; Middle Aged; Renal Dialysis; Renal Insufficiency - immunology, therapy; Saponins - administration & dosage; Vaccination - methods; Aged, 80 and over; Animals; Antibodies, Viral - blood; Drug Combinations; Female; France; Hepatitis B Vaccines - adverse effects, immunology; Humans; info:eu-repo/semantics/article

Open access content. Open access content
info:eu-repo/semantics/restrictedAccess

English

UCDLC oai:dial.uclouvain.be:boreal:113224
boreal:113224
info:doi/10.1016/j.vaccine.2010.12.009
info:pmid/21167859
urn:ISSN:0264-410X
urn:EISSN:1873-2518
1130512409

UNIVERSITE CATHOLIQUE DE LOUVAIN
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