Hepatitis B virus vaccine in chronic kidney disease: Improved immunogenicity by adjuvants? A meta-analysis of randomized trials

Fabrizio Fabrizi, Vivek Dixit, Piergiorgio Messa, Paul Martin

Research output: Contribution to journalArticle

15 Citations (Scopus)

Abstract

Background: Patients with chronic kidney disease typically show an impaired immune response to hepatitis B virus vaccine compared with healthy individuals. A variety of inherited or acquired factors have been implicated in this diminished response. Some authors suggested a benefit with adjuvantation to improve the immunogenicity of existing HBV vaccines. Aim: To evaluate the efficacy and safety of adjuvantation for hepatitis B virus vaccine in patients with chronic kidney disease. Methods: Only prospective, randomized clinical trials (RCTs) were included. We used the random effects model of DerSimonian and Laird with heterogeneity and subgroups analyses. The primary end-point of interest was the seroprotection rate after HBV vaccination with recombinant vaccine plus adjuvants (study group) versus recombinant vaccine alone (control group). Results: We identified ten studies involving 1228 unique patients with chronic kidney disease. Pooling of study results did not show a significant increase in seroprotection rate among study (HBV recombinant vaccine plus adjuvants) versus control (HBV recombinant alone) patients; the pooled odds ratio of seroprotection rate was 1.47 (95% CI: 0.88; 2.46, NS). The pooled OR for seroresponse rate after HBV vaccine (adjuvanted recombinant vaccine versus recombinant vaccine alone) did not change in the subgroup of studies based on novel adjuvant systems (i.e., HBV-AS04 or HBV-AS02), the pooled OR was 2.22 (95% CI, 0.72; 6.78), NS. Q-test for heterogeneity being 10.819 (P= 0.004). Conclusions: Our meta-analysis showed that adjuvanted hepatitis B vaccine did not significantly improve the seroprotection rate in patients with renal insufficiency. These results do not support adjuvantation as an approach to increase the immunogenicity of existing recombinant vaccines towards HBV in this high-risk population.

Original languageEnglish
Pages (from-to)2295-2300
Number of pages6
JournalVaccine
Volume30
Issue number13
DOIs
StatePublished - Mar 16 2012

Fingerprint

Hepatitis B Vaccines
Synthetic Vaccines
Hepatitis B virus
recombinant vaccines
kidney diseases
Chronic Renal Insufficiency
meta-analysis
adjuvants
Meta-Analysis
immune response
vaccines
Vaccines
randomized clinical trials
hepatitis B
odds ratio
Renal Insufficiency
Vaccination
Randomized Controlled Trials
Odds Ratio
vaccination

Keywords

  • Adjuvants
  • Chronic kidney disease
  • Dialysis
  • Hepatitis B virus
  • Meta-analysis
  • Vaccine

ASJC Scopus subject areas

  • Immunology and Microbiology(all)
  • Infectious Diseases
  • Public Health, Environmental and Occupational Health
  • veterinary(all)
  • Molecular Medicine

Cite this

Hepatitis B virus vaccine in chronic kidney disease : Improved immunogenicity by adjuvants? A meta-analysis of randomized trials. / Fabrizi, Fabrizio; Dixit, Vivek; Messa, Piergiorgio; Martin, Paul.

In: Vaccine, Vol. 30, No. 13, 16.03.2012, p. 2295-2300.

Research output: Contribution to journalArticle

Fabrizi, Fabrizio ; Dixit, Vivek ; Messa, Piergiorgio ; Martin, Paul. / Hepatitis B virus vaccine in chronic kidney disease : Improved immunogenicity by adjuvants? A meta-analysis of randomized trials. In: Vaccine. 2012 ; Vol. 30, No. 13. pp. 2295-2300.
@article{48dec0f379294ef8a326b115d2b5fa05,
title = "Hepatitis B virus vaccine in chronic kidney disease: Improved immunogenicity by adjuvants? A meta-analysis of randomized trials",
abstract = "Background: Patients with chronic kidney disease typically show an impaired immune response to hepatitis B virus vaccine compared with healthy individuals. A variety of inherited or acquired factors have been implicated in this diminished response. Some authors suggested a benefit with adjuvantation to improve the immunogenicity of existing HBV vaccines. Aim: To evaluate the efficacy and safety of adjuvantation for hepatitis B virus vaccine in patients with chronic kidney disease. Methods: Only prospective, randomized clinical trials (RCTs) were included. We used the random effects model of DerSimonian and Laird with heterogeneity and subgroups analyses. The primary end-point of interest was the seroprotection rate after HBV vaccination with recombinant vaccine plus adjuvants (study group) versus recombinant vaccine alone (control group). Results: We identified ten studies involving 1228 unique patients with chronic kidney disease. Pooling of study results did not show a significant increase in seroprotection rate among study (HBV recombinant vaccine plus adjuvants) versus control (HBV recombinant alone) patients; the pooled odds ratio of seroprotection rate was 1.47 (95{\%} CI: 0.88; 2.46, NS). The pooled OR for seroresponse rate after HBV vaccine (adjuvanted recombinant vaccine versus recombinant vaccine alone) did not change in the subgroup of studies based on novel adjuvant systems (i.e., HBV-AS04 or HBV-AS02), the pooled OR was 2.22 (95{\%} CI, 0.72; 6.78), NS. Q-test for heterogeneity being 10.819 (P= 0.004). Conclusions: Our meta-analysis showed that adjuvanted hepatitis B vaccine did not significantly improve the seroprotection rate in patients with renal insufficiency. These results do not support adjuvantation as an approach to increase the immunogenicity of existing recombinant vaccines towards HBV in this high-risk population.",
keywords = "Adjuvants, Chronic kidney disease, Dialysis, Hepatitis B virus, Meta-analysis, Vaccine",
author = "Fabrizio Fabrizi and Vivek Dixit and Piergiorgio Messa and Paul Martin",
year = "2012",
month = "3",
day = "16",
doi = "10.1016/j.vaccine.2012.01.064",
language = "English",
volume = "30",
pages = "2295--2300",
journal = "Vaccine",
issn = "0264-410X",
publisher = "Elsevier BV",
number = "13",

}

TY - JOUR

T1 - Hepatitis B virus vaccine in chronic kidney disease

T2 - Improved immunogenicity by adjuvants? A meta-analysis of randomized trials

AU - Fabrizi, Fabrizio

AU - Dixit, Vivek

AU - Messa, Piergiorgio

AU - Martin, Paul

PY - 2012/3/16

Y1 - 2012/3/16

N2 - Background: Patients with chronic kidney disease typically show an impaired immune response to hepatitis B virus vaccine compared with healthy individuals. A variety of inherited or acquired factors have been implicated in this diminished response. Some authors suggested a benefit with adjuvantation to improve the immunogenicity of existing HBV vaccines. Aim: To evaluate the efficacy and safety of adjuvantation for hepatitis B virus vaccine in patients with chronic kidney disease. Methods: Only prospective, randomized clinical trials (RCTs) were included. We used the random effects model of DerSimonian and Laird with heterogeneity and subgroups analyses. The primary end-point of interest was the seroprotection rate after HBV vaccination with recombinant vaccine plus adjuvants (study group) versus recombinant vaccine alone (control group). Results: We identified ten studies involving 1228 unique patients with chronic kidney disease. Pooling of study results did not show a significant increase in seroprotection rate among study (HBV recombinant vaccine plus adjuvants) versus control (HBV recombinant alone) patients; the pooled odds ratio of seroprotection rate was 1.47 (95% CI: 0.88; 2.46, NS). The pooled OR for seroresponse rate after HBV vaccine (adjuvanted recombinant vaccine versus recombinant vaccine alone) did not change in the subgroup of studies based on novel adjuvant systems (i.e., HBV-AS04 or HBV-AS02), the pooled OR was 2.22 (95% CI, 0.72; 6.78), NS. Q-test for heterogeneity being 10.819 (P= 0.004). Conclusions: Our meta-analysis showed that adjuvanted hepatitis B vaccine did not significantly improve the seroprotection rate in patients with renal insufficiency. These results do not support adjuvantation as an approach to increase the immunogenicity of existing recombinant vaccines towards HBV in this high-risk population.

AB - Background: Patients with chronic kidney disease typically show an impaired immune response to hepatitis B virus vaccine compared with healthy individuals. A variety of inherited or acquired factors have been implicated in this diminished response. Some authors suggested a benefit with adjuvantation to improve the immunogenicity of existing HBV vaccines. Aim: To evaluate the efficacy and safety of adjuvantation for hepatitis B virus vaccine in patients with chronic kidney disease. Methods: Only prospective, randomized clinical trials (RCTs) were included. We used the random effects model of DerSimonian and Laird with heterogeneity and subgroups analyses. The primary end-point of interest was the seroprotection rate after HBV vaccination with recombinant vaccine plus adjuvants (study group) versus recombinant vaccine alone (control group). Results: We identified ten studies involving 1228 unique patients with chronic kidney disease. Pooling of study results did not show a significant increase in seroprotection rate among study (HBV recombinant vaccine plus adjuvants) versus control (HBV recombinant alone) patients; the pooled odds ratio of seroprotection rate was 1.47 (95% CI: 0.88; 2.46, NS). The pooled OR for seroresponse rate after HBV vaccine (adjuvanted recombinant vaccine versus recombinant vaccine alone) did not change in the subgroup of studies based on novel adjuvant systems (i.e., HBV-AS04 or HBV-AS02), the pooled OR was 2.22 (95% CI, 0.72; 6.78), NS. Q-test for heterogeneity being 10.819 (P= 0.004). Conclusions: Our meta-analysis showed that adjuvanted hepatitis B vaccine did not significantly improve the seroprotection rate in patients with renal insufficiency. These results do not support adjuvantation as an approach to increase the immunogenicity of existing recombinant vaccines towards HBV in this high-risk population.

KW - Adjuvants

KW - Chronic kidney disease

KW - Dialysis

KW - Hepatitis B virus

KW - Meta-analysis

KW - Vaccine

UR - http://www.scopus.com/inward/record.url?scp=84863397336&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84863397336&partnerID=8YFLogxK

U2 - 10.1016/j.vaccine.2012.01.064

DO - 10.1016/j.vaccine.2012.01.064

M3 - Article

C2 - 22285268

AN - SCOPUS:84863397336

VL - 30

SP - 2295

EP - 2300

JO - Vaccine

JF - Vaccine

SN - 0264-410X

IS - 13

ER -