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

Tielemans, Christian L;Vlasak, Jiri;Kosa, Dezider;Billiouw, Jean-Marie;Surquin, Murielle;et.al.
(2011) Vaccine — Vol. 29, n° 6, p. 1159-1166 (2011)

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Authors
  • Tielemans, Christian L
    Author
  • Vlasak, Jiri
    Author
  • Kosa, Dezider
    Author
  • Billiouw, Jean-Marie
    Author
  • Jadoul, MichelUCLouvain
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  • Surquin, Murielle
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Abstract
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.
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Tielemans, C. L., Vlasak, J., Kosa, D., Billiouw, J.-M., Verpooten, G. A., Mezei, I., Ryba, M., Peeters, P. C., Mat, O., Jadoul, M., Polakovic, V., Dhaene, M., Treille, S., Kuriyakose, S. O., Leyssen, M., Houard, S. A., & Surquin, M. (2011). 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. Vaccine, 29(6), 1159-1166. https://doi.org/10.1016/j.vaccine.2010.12.009 (Original work published 2011)