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)
|
|
|
|
| |
|