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Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet].

Meta-analysis: intradermal vs. intramuscular vaccination against hepatitis B virus in patients with chronic kidney disease

F Fabrizi, V Dixit, M Magnini, A Elli, and P Martin.

Review published: 2006.

CRD summary

This review compared the administration of HBV vaccination through the ID or IM route in CKD patients. The authors concluded that ID vaccination yields a higher seroprotection rate, despite a lower vaccine dose. The reliability of the authors' conclusions is uncertain, given the lack of reporting for parts of the review process and the study limitations.

Authors' objectives

To compare the administration of hepatitis B virus (HBV) vaccination through intradermal (ID) or intramuscular (IM) route in chronic kidney (CKD) patients.

Searching

A MEDLINE and EMBASE search covering the period from 1980 to June 2005 was undertaken. Additional studies were sought through reference lists of qualitative topic reviews, published clinical trials, current contents searches and manual searches. Studies were restricted to those published in peer-reviewed journals. Search terms were reported.

Study selection

Controlled trials comparing ID versus IM administration of hepatitis B virus vaccine were eligible for inclusion. Patients with CKD were eligible for inclusion, including those who underwent primary vaccination schedule or those who had failed to respond to prior IM vaccine schedule against hepatitis B. Included studies recruited haemodialysis (HD) patients, chronic renal failure (CRF) patients, peritoneal dialysis (PD) patients and a combination of HD and PD patients. Trials concerning renal transplant patients were excluded. The mean age of participants ranged from 45 to 67 years and the proportion of males from 50 to 79%. The included trials delivered HBV vaccine at different doses and frequencies. The primary outcome was seroprotection rate at the completion of vaccination course with further outcomes including peak anti-HBs antibody titres after vaccine schedule and adverse events of the vaccine either at the injection site or systemic reactions, liver-related morbidity and mortality. Follow-up ranged from 6 to 60 months.

Two reviewers independently assessed studies for inclusion in the review and any disagreements were resolved through consensus.

Assessment of study quality

The authors did not state how they assessed validity. They did report on allocation and how many trials were double-blind.

Data extraction

The authors did not state how the data were extracted for the review, though data extraction was conducted independently by two investigators.

Peto odds ratios (OR) and 95% confidence intervals (CI) for dichotomous outcomes on failure to respond to vaccination (ID versus IM vaccine) were calculated for each study.

Methods of synthesis

Meta-analyses were performed using a fixed-effect model and DerSimonian and Laird random-effects model.

Heterogeneity between the trials was investigated using the Cochrane Q test. Potential publication bias was assessed using funnel plot asymmetry.

Results of the review

Twelve studies were included (n=640), 11 of which were randomised controlled trials (RCTs).

The pooled OR of failure to respond to HBV at completion of vaccination against HBV was 0.36 (95% CI: 0.21, 0.62) using a fixed effects model, with no evidence of heterogeneity. Pooled OR of failure to respond to vaccination over follow-up was 1.1 (95% CI: 0.47, 2.5) using a random effects model, with weak evidence of heterogeneity (p=0.04). The mean estimate for peak anti-HBs antibody titres for ID compared with IM was 341 ± 226 versus 333 ± 259 mIU/L.

A significant association between seroprotection rate and number of vaccine shots was evident (p=0.002). No liver-related adverse-events were reported in the studies, with the rate of minor local/systemic reactions after ID vaccine varying between 0 to 100% and after IM vaccine between 0 to 36%. Liver related adverse-events were not recorded.

There was no evidence of publication bias.

Authors' conclusions

Findings show that ID vaccination, compared with IM vaccination, against the hepatitis B virus is associated with a higher seroprotection rate, despite a lower vaccine dose with ID. The seroprotection rate over follow-up was similar for both protocols.

CRD commentary

The review addressed a clearly stated research question and undertook an adequate search of two databases and reference lists. The search was restricted to publications in peer-reviewed journals. The methods used for data extraction were not reported but some assessment of the methodological quality of the included studies was undertaken, although the authors later report that the trials were not of high methodological quality. The authors undertook appropriate steps to minimise study selection bias, as well as an assessment of publication bias. The use of meta-analysis was appropriate and study heterogeneity was assessed, with weak evidence for heterogeneity apparent in one of the analyses. The included studies were small with wide confidence intervals for some outcomes. Given the poor quality of the included studies and the small study numbers, the reliability of the authors' conclusions is uncertain.

Implications of the review for practice and research

Practice: The authors did not state any implications for practice.

Research: Further controlled trials are required to ascertain if the greater seroprotection rates associated with ID vaccination results in reduced incidence of de novo HBV amongst CKD patients. Future trials should also seek to improve their methodological quality.

Funding

Project Glomerulonephritis.

Bibliographic details

Fabrizi F, Dixit V, Magnini M, Elli A, Martin P. Meta-analysis: intradermal vs. intramuscular vaccination against hepatitis B virus in patients with chronic kidney disease Alimentary Pharmacology and Therapeutics 2006; 24(3): 497-506. [PubMed: 16886915]

Indexing Status

Subject indexing assigned by NLM

MeSH

Administration, Cutaneous; Aged; Controlled Clinical Trials as Topic; Female; Hepatitis B Vaccines /administration & dosage; Hepatitis B, Chronic /prevention & control; Humans; Kidney Failure, Chronic /complications; Male; Middle Aged; Risk Factors

AccessionNumber

12006004611

Database entry date

22/04/2009

Record Status

This is a critical abstract of a systematic review that meets the criteria for inclusion on DARE. Each critical abstract contains a brief summary of the review methods, results and conclusions followed by a detailed critical assessment on the reliability of the review and the conclusions drawn.

CRD has determined that this article meets the DARE scientific quality criteria for a systematic review.

Copyright © 2014 University of York.

PMID: 16886915

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