Back to Search
Start Over
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
- Source :
-
Vaccine . Feb2011, Vol. 29 Issue 6, p1159-1166. 8p. - Publication Year :
- 2011
-
Abstract
- 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 (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. [ABSTRACT FROM AUTHOR]
Details
- Language :
- English
- ISSN :
- 0264410X
- Volume :
- 29
- Issue :
- 6
- Database :
- Academic Search Index
- Journal :
- Vaccine
- Publication Type :
- Academic Journal
- Accession number :
- 57517673
- Full Text :
- https://doi.org/10.1016/j.vaccine.2010.12.009