1. ¹Nephroloyg/Dialysis Unit, Department of Medicine, National University Hospital of Malaysia, Kuala Lumpur, Malaysia
2. ²Vaccination and Travel Medicine Center, Poliklinka II, Hradec Kralove, Czech Republic
3. ³Department of Infectious Diseases, School of Medicine and University Hospital, Hradec Kralove, Czech Republic
4. ⁴Dialysis Unit, La Paz Hospital, Madrid, Spain
5. ⁵Department of Preventive Medicine, Clinic Hospital, Barcelona, Spain
6. ⁶Department of Preventive Medicine, Hospital Carlos Haya, Málaga, Spain
7. ⁷Nephrology Department, Hospital Carlos Haya, Málaga, Spain
8. ⁸Clinical Development Operations Center, GlaxoSmithKline Biologicals, Bangalore, India
9. ⁹Clinical Regulatory & Labelling, GlaxoSmithKline Biologicals, Rixensart, Belgium
10. ¹⁰Worldwide Clinical Development, GlaxoSmithKline Biologicals, Rixensart, Belgium

Correspondence: B Hoet, GlaxoSmithKline Biologicals, 89 Rue de l'Institut, 1330 Rixensart, Belgium. E-mail: bernard.hoet@gskbio.com

Received 28 February 2007; Revised 15 September 2007; Accepted 9 October 2007; Published online 26 December 2007.

Abstract

Prehemodialysis and hemodialysis patients are at an increased risk of hepatitis B infection and have an impaired immune response to hepatitis B vaccines. We evaluated the immune response to the new adjuvant of hepatitis B vaccine AS04 (HBV-AS04) in this population. We measured antibody persistence for up to 42 months, and the anamnestic response and safety of booster doses in patients who were no longer seroprotected. The primary vaccination study showed that HBV-AS04 elicited an earlier antibody response and higher antibody titers than four double doses of standard hepatitis B vaccine. Seroprotection rates were significantly higher in HBV-AS04 recipients throughout the study. The decline in seroprotection over time was significantly less in the HBV-AS04 group with significantly fewer primed patients requiring a booster dose over the follow-up period. Solicited/unsolicited adverse events were rare following booster administration. Fifty-seven patients experienced a serious adverse event during the follow-up; none of which was vaccine related. When HBV-AS04 was used as the priming immunogen, the need for a booster dose occurred at a longer time compared to double doses of standard hepatitis B vaccine. Hence, in this population, the HBV-AS04 was immunogenic, safe, and well-tolerated both as a booster dose after HBV-AS04 or standard hepatitis B vaccine priming.