Recombinant Hepatitis B Vaccine Adjuvanted With AS04 in Dialysis Patients: A Prospective Cohort Study

Background/Aims: Patients undergoing maintenance dialysis have an unsatisfactory response to vaccination, including to hepatitis B vaccine. A recombinant HB vaccine containing a new adjuvant system AS04 (HBV-AS04) has been recently developed; a few data exist on the immunogenicity and safety of HBV-...

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Bibliographic Details
Published in:Kidney & blood pressure research 2015-01, Vol.40 (6), p.584-592
Main Authors: Fabrizi, Fabrizio, Tarantino, Antonio, Castelnovo, Claudia, Martin, Paul, Messa, PierGiorgio
Format: Article
Language:English
Subjects:
Adjuvant
Adjuvants, Immunologic
Adult
Aged
Aging - immunology
Cohort Studies
Dialysis
Female
Hepatitis B Surface Antigens - blood
Hepatitis B vaccine
Hepatitis B Vaccines - administration & dosage
Hepatitis B Vaccines - adverse effects
Hepatitis B Vaccines - immunology
Humans
Immunization Schedule
Immunogenicity
Injections, Intramuscular
Lipid A - administration & dosage
Lipid A - adverse effects
Lipid A - analogs & derivatives
Lipid A - immunology
Male
Middle Aged
Original Paper
Prospective Studies
Renal Dialysis
Safety
Vaccines, Synthetic
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Summary:Background/Aims: Patients undergoing maintenance dialysis have an unsatisfactory response to vaccination, including to hepatitis B vaccine. A recombinant HB vaccine containing a new adjuvant system AS04 (HBV-AS04) has been recently developed; a few data exist on the immunogenicity and safety of HBV-AS04 among patients undergoing regular dialysis. All hepatitis B virus-seronegative patients with undetectable antibody against HBsAg undergoing maintenance dialysis at two units were prospectively included. Methods: Patients received four 20-mcg doses of HBV-AS04 by intramuscular route (deltoid muscle) at months 0,1,2, and 3. Anti-HB surface antibody concentrations were measured at intervals of 1, 2, 3, 4, and 12 months. Univariate and multivariate analyses determined which parameters predicted immunologic response to HBV-AS04 vaccine. Results: 102 patients were enrolled and 91 completed the study. At completion of the vaccination schedule, using per-protocol analysis, 76 of 91 (84%) had antibody titers ≥10 mIU/mL with anti-HBs geometric antibody concentrations (GMCs) of 385.25 mIU/mL. The sero-protection rate at month 12 was 84% (48/57) with lower GMCs (62.74 mIU/mL, P
ISSN:1420-4096
1423-0143
DOI:10.1159/000368534