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: Results of two open, randomized, comparative tri

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Vaccine. 2010 Dec 15. [Epub ahead of print]

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: Results of two open,

randomized, comparative trials.

Tielemans CL, Vlasak J, Kosa D, Billiouw JM, Verpooten GA, Mezei I, Ryba M,

Peeters PC, Mat O, Jadoul MY, Polakovic V, Dhaene M, Treille S, Kuriyakose SO,

Leyssen M, Houard SA, Surquin M.

ULB Hôpital Erasme, Département de Néphrologie, Dialyse et Transplantation,

Bruxelles, Belgium.

Abstract

An investigational AS02(v)-adjuvanted hepatitis B (HB-AS02) was compared with a

licensed conventional recombinant hepatitis B vaccine (HBVAXPROâ„¢; 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.

Copyright © 2010. Published by Elsevier Ltd.

PMID: 21167859 [PubMed - as supplied by publisher]