Publication
Title
Immunogenicity and safety of an investigational AS02v-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
Author
Abstract
An investigational AS02v-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 (3192) and 64.6 (2992) 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 6.9 mIU/ml), with antibody concentrations ≥100 mIU/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 ≥100 mIU/ml, and anti-HBs GMCs were 1726.8 and 189.5 mIU/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.
Language
English
Source (journal)
Vaccine / International Society for Vaccines. - Amsterdam
Publication
Amsterdam : 2011
ISSN
0264-410X
DOI
10.1016/J.VACCINE.2010.12.009
Volume/pages
29 :6 (2011) , p. 1159-1166
ISI
000287339800009
Full text (Publisher's DOI)
UAntwerpen
Faculty/Department
Research group
Publication type
Subject
Affiliation
Publications with a UAntwerp address
External links
Web of Science
Record
Identifier
Creation 17.05.2011
Last edited 15.11.2022
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