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The accelerated hepatitis B virus vaccination schedule among hemodialysis patients, does it work? A randomized controlled trial

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Abstract

Background

Hemodialysis patients possess particular attributes which increase the susceptibility to hepatitis B virus (HBV) infections. HBV vaccination significantly decreased the number of new HBV-infected patients. However, the conventional vaccination schedule requires a 6-months duration. This study aimed to examine the efficacy the accelerated vaccination schedule among hemodialysis patients.

Methods

In this study, 202 consecutive hemodialysis patients at New Jeddah hospital were enrolled. The inclusion criteria were: (1) age was above 18 years, (2) all patients had undetectable HBV surface antigen and antibody. Exclusion criteria included: (1) patient had a positive serum HBV surface antigen and antibody using enzyme-linked immunosorbent assay; (2) patient received a previous course of HBV vaccine, (3) patient who was pregnant. Patients were sequentially randomized to receive either Hepatitis B recombinant DNA vaccine (conventional schedule) or to receive combined hepatitis A and B vaccine injection (accelerated schedule). Testing for HBV surface antibodies was done one and three months after completion of the dosage schedule. The primary outcome was the proportion of seroprotection (defined by serum HBV surface antibodies ≥ 10 mIU/ml). Adverse reactions were evaluated regarding both fever and post-injection pain scale.

Results

Patients’ age ranged from 18 to 71 years.After 1 and 3 months of completion of the vaccination schedule, there was no statistical difference in the proportion of seroprotected patients among both groups.

Conclusion

Accelerated vaccination schedule using combined hepatitis A and B vaccine may be beneficial for HBV seroprotection among hemodialysis patients.

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Acknowledgements

The author would like to thank both the dialysis unit nurse team and the laboratory team for their help in recording of patient data and laboratory results.

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Correspondence to Mahmoud Hamada Imam.

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Conflict of interest

The author declares that he has no conflict of interest. The author did not receive any funding for this study.

Ethical approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Informed consent

Written informed consent was obtained from each patient before the enrollment in the study after a detailed explanation of the study process and clinical and biochemical aspects of the study.

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Imam, M.H. The accelerated hepatitis B virus vaccination schedule among hemodialysis patients, does it work? A randomized controlled trial. J Nephrol 30, 803–809 (2017). https://doi.org/10.1007/s40620-017-0443-5

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  • DOI: https://doi.org/10.1007/s40620-017-0443-5

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