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
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 va...
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| Main Authors: | , , , , , , , , , , , , , , , , |
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| Format: | Article (Journal) |
| Language: | English |
| Published: |
2011
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| In: |
Vaccine
Year: 2011, Volume: 29, Issue: 6, Pages: 1159-1166 |
| ISSN: | 1873-2518 |
| DOI: | 10.1016/j.vaccine.2010.12.009 |
| Online Access: | Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1016/j.vaccine.2010.12.009 Verlag, lizenzpflichtig, Volltext: https://www.sciencedirect.com/science/article/pii/S0264410X10017470 
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| Author Notes: | Christian L. Tielemans, Jiri Vlasak, Dezider Kosa, Jean-Marie Billiouw, Gert A. Verpooten, Ilona Mezei, Miroslav Ryba, Patrick C. Peeters, Olivier Mat, Michel Y. Jadoul, Vladimir Polakovic, Michel Dhaene, Serge Treille, Sherine O. Kuriyakose, Maarten Leyssen, Sophie A. Houard, Murielle Surquin |
MARC
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| 245 | 1 | 0 | |a 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 |b results of two open, randomized, comparative trials |c Christian L. Tielemans, Jiri Vlasak, Dezider Kosa, Jean-Marie Billiouw, Gert A. Verpooten, Ilona Mezei, Miroslav Ryba, Patrick C. Peeters, Olivier Mat, Michel Y. Jadoul, Vladimir Polakovic, Michel Dhaene, Serge Treille, Sherine O. Kuriyakose, Maarten Leyssen, Sophie A. Houard, Murielle Surquin |
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| 520 | |a 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. | ||
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