Hepatitis B Vaccination Regimen for Adult Chronic Renal Failure Patients
Guideline and
Procedure
Hepatitis B vaccination regimen for adult chronic renal
failure patients
Sites where Guideline and Procedure
applies
Target audience:
All HNE facilities where a patient receives
hemodialysis
Nephrology clinical staff who provide care to
hemodialysis patients
Description
This Guideline and Procedure applies to:
1. Adults
2. Children up to 16 years
3. Neonates – less than 29 days
Yes
Yes
No
Keywords
Hepatitis B, Vaccination, chronic renal failure,
nephrology
Replaces Existing Guideline and Procedure Yes
Registration Number(s) and/or name and of JHH Nephrology SWP N.4.15
Superseded Documents
Related Legislation, Australian Standards, NSW Health Policy Directive, NSQHS
Standard/EQuIP Criterion and/or other, HNE Health Documents, Professional Guidelines,
Codes of Practice or Ethics::
 NSW Health Policy Directive 2007_079 Correct patient, Correct procedure, correct site
http://www.health.nsw.gov.au/policies/pd/2007/pdf/PD2007_079.pdf
 NSW Health Policy PD 2005_406 Consent to Medical Treatment
http://www.health.nsw.gov.au/policies/PD/2005/pdf/PD2005_406.pdf
 NSW Health Policy Directive PD 2007_036 Infection Control Policy
http://www.health.nsw.gov.au/policies/pd/2007/pdf/PD2007_036.pdf
Prerequisites (if required)
Registered Nurse or Endorsed Enrolled Nurse.
Current, signed medication order.
Guideline and Procedure Note This document reflects what is currently regarded as safe and
appropriate practice. The guideline section does not replace the
need for the application of clinical judgment in respect to each
individual patient but the procedure/s requires mandatory
compliance. If staff believe that the procedure/s should not
apply in a particular clinical situation they must seek advice from
their unit manager/delegate and document the variance in the
patient’s health record.
If this document needs to be utilised in a Non Clinical Area
please liaise with the Infection control Service to ensure the
appropriateness of the information contained within the Guideline
and Procedure.
Position responsible for the
Tier 2 Executive or Network or Stream Clinical Leader (or
Guideline and Procedure and applicable committee) with authority to authorise
authorised by
Contact Person
Tina Straker
Contact Details
02 67769912
Date authorised
This Guideline and
Yes
Procedure contains advice
Approval gained from HNE Quality Use of Medicines Committee
on therapeutics
on 9th April 2013
Date of Issue
Review due date
TRIM Number
Version Number 2
Feb 2013
Hepatitis B Vaccination Regimen for Adult Chronic Renal Failure Patients
1. Targeted consultation – Consultation was obtained across the Area Renal network including
Nephrologists, Chronic Kidney Disease and Dialysis Nursing staff.
Note: Over time links in this document may cease working. Where this occurs please source the document
in the PPG Directory at: http://ppg.hne.health.nsw.gov.au/
RISK STATEMENT
Although the rate of Hepatitis B infections in dialysis patients is decreasing, the success rate
of immunization is lower (around 50–60%) in hemodialysis patients because of depressed
immunity in renal failure. Malnutrition, malignancies, IV iron overload, hepatitis C infection,
inadequate dialysis, use of low-biocompatible material, hyperparathyroidism, anemia and old
age are all factors contributing to altered immunity. Therefore, different strategies have been
proposed to improve the response rate in hemodialysis patients: reinforced intramuscular and
intra dermal regimes for immunization for Hepatitis B in hemodialysis patients (Mat etal
2006:49).
RISK CATEGORY: Clinical Care & Patient Safety
OUTCOMES
1
To make certain that all patients referred to the Pre dialysis pathway and patients already
commenced on dialysis are immunized against Hepatitis B.
2
To utilize Intra Dermal vaccination if the first line Intra Muscular immunization is
unsuccessful
ABBREVIATIONS & GLOSSARY
Abbreviation/Word
Definition
CKD
Chronic Kidney Disease
HBIG
Hepatitis B Immune Globulin
HBsAG
Hepatitis B Surface Antigen
HBV
Hepatitis B virus
IM
Intra – Muscular
ID
Intra – Dermal
GUIDELINE
This Guideline does not replace the need for the application of clinical judgment in respect to each
individual patient.
Hepatitis B vaccinations are an essential part of the pre-dialysis pathway. It is also important that
patients already commenced on dialysis are screened and immunized if necessary. A total of 3
Hepatitis B vaccines are given at 0, 1 and 6 months.
Four to eight weeks following the final vaccination a blood test is conducted to determine
immunity status. A key reason to consider for non-response to vaccine is that the patient might be
HBsAg positive, so a check carriage status should be made prior to giving further doses of the
vaccine.
If Hepatitis B immunity is not reached after the 3rd dose, further doses should be administered,
this can be as a 4th dose or a further three doses at monthly intervals, with serology attended at
least 4 weeks following last dose.
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Hepatitis B Vaccination Regimen for Adult Chronic Renal Failure Patients
Intradermal administration is also an option of vaccination if the patient does not seroconvert after
the Intra Muscular immunizations have been administered.
Pre- Dialysis Patients- Following referral from nephrologist to the pre dialysis pathway virology is
arranged by the Pre Dialysis Coordinator. If immunity is not detected, a prescription for Hepatitis
B vaccine is organised. The patient is to collect the script and arrange for their GP to administer.
Patients are to inform Coordinator at commencement of vaccine regime. Home dialysis patients
also need to follow the same process outlined above for Pre-Dialysis patients.
If immunity is not detected or patient has not been vaccinated on commencement of dialysis
treatments, consult with Nephrologist to arrange immunization as soon as possible.
PROCEDURE
This procedure requires mandatory compliance.
Patient Preparation
It is mandatory to ensure that the patient has received appropriate information to provide
informed consent and, that patient identification, correct procedure and correct site process is
completed prior to any procedure.
Staff Preparation
It is mandatory for staff to follow relevant: “Five moments of hand hygiene”, infection control,
moving safely/safe manual handling, and documentation practices.
Contraindications:
Those with documented evidence or a reaction to the HBV vaccine or any components of the
vaccine.
Equipment Requirements
•
•
•
•
Alcohol hand gel
Personal Protective Equipment
Pathology request for screening
Prescription for vaccine
Procedure Steps
1. All Pre- Dialysis patients and patients already commenced on hemodialysis are to
complete 3 vaccination course as per the current Hepatitis B vaccine currently available.
Vaccines are to be given at 0, 1 and 6 months.
Current doses that are recommended via Intra Muscular Injection (Engerix Dialysis Formulation):
1.
0 months- 40 microgram/mL
2.
1 months- 40 microgram/mL
3.
6 months- 40 microgram/mL
4.
4 to 8 weeks following 3rd vaccination serology should be attended to determine immunity
5.
If Hepatitis B surface antibody falls below recommended levels (>10 International units
per litre) or shows poor seroconversion after initial immunization regime, a single booster
can also be offered. If poor seroconversion still remains, the Intra Dermal route of
immunization should be considered.
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Hepatitis B Vaccination Regimen for Adult Chronic Renal Failure Patients
Administration of IM Injection:
• Patients receiving anticoagulant therapy during dialysis should have the vaccine administered
30 minutes prior to dialysis (for IM Injections).
• Check patient, order and vaccine dose and expiry date.
• Explain the procedure to the patient and obtain consent and provide with consumer product
information leaflet.
• The vaccine is a ready to use suspension and should be shaken well before use. The vaccine
should be a slightly opaque, white suspension, discard if appears otherwise.
• Prepare the site with alcohol swab and allow to dry thoroughly (alcohol may affect the
effectiveness of the vaccine) administer the vaccine deep in the deltoid muscle. The schedule is
as per the prescribing information: IM injections (deltoid muscle) at 0, 1 and 6 months.
• Following administration, the patient should stay in the area for 15 minutes to observe for any
signs of adverse reactions.
• The vaccine must be signed for and the batch number noted, on the Immunization Record Form
which is to be kept at the front of the patient’s most current medical record chart (or as per local
hospital procedures).
• The Hepatitis B surface antibody should be checked approximately four to eight weeks after the
last injection. A 4th dose may be required, if the anti-HBs <10 International units per litre.
• If the Anti-HBs International units per litre is still <10 following booster vaccination, it is
advisable to proceed with Intra-Dermal HBV vaccination.
Administration of Intra-Dermal Injection:
• Patients receiving anticoagulant therapy during dialysis can have the vaccine administered via
the Intra-Dermal Injection method during the treatment as complications are less likely from this
injection method.
• Check patient, order and vaccine dose and expiry date.
• Explain the procedure to the patient and obtain consent and provide with consumer product
information leaflet.
• The vaccine is a ready to use suspension and should be shaken well before use, the vaccine
should be a slightly opaque, white suspension, discard if appears otherwise.
• Registered Nurses who have undergone ward-based immunization training can administer the
Intra-Dermal injection. Prepare the site with alcohol swab and prepare two separate Intra-Dermal
injections of 0.25ml (5ug Engerix B) via an insulin syringe or 27G needle. Inject using IntraDermal Injection technique into the volar aspect of the forearm. Ideally the injection sites will be
approx. 4cm apart in width, and be on the arm with no vascular access.
• The schedule is on a weekly basis for 8 weeks – a total of 80ug. A schedule outlining dates as
well as a medical prescription will be organised by the Hemodialysis Infection Control portfolio
group or allocated nurse.
• Following administration the patient should stay in the area for 15 minutes to observe for any
signs of adverse reactions.
• The vaccine must be signed for and the batch number noted, on the Immunization record form
which is to be kept at the front of the patients most current medical record chart (or as per local
hospital policy).
• The Hepatitis B surface antibody should be checked approximately four to eight weeks after the
last injection. If antibody titre continues to be <10 IU/L, the notes should reflect that the patient is
an Intra Dermal Hepatitis B non-responder and no further Hepatitis B vaccination undertaken.
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Hepatitis B Vaccination Regimen for Adult Chronic Renal Failure Patients
APPENDICES
Appendix 1: Five Moments of Hand Hygiene
REFERENCES
Australia Immunisation Handbook 9th Edition, Section 3.6 Hepatitis B
Energix-B Product Information
Hand Hygiene Australia 2008: Five Moments for Hand Hygiene
Hepatitis Australia. (2009). Hepatitis B. Accessed 7/01/10
http://www.hepatitisaustralia.com/about_hepatitis/hep_b.html
Mat, O, Mestrez F, Beauwens, R, Muniz-Martinez, M, and Dhaene. 2006. Primary high-dose
intradermal hepatitis B vaccination in hemodialysis: Cost – effectiveness evaluation at 2 years,
Hemodialysis International 2006; 10: 49-55
Queensland Government, Queensland Health, Procedure no. 01191/V1/2012. Hepatitis B
Immunisation for Renal Patients: Monitoring. 2012
FEEDBACK
Any feedback on this document should be sent to the Contact Officer listed on the front page.
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Hepatitis B Vaccination Regimen for Adult Chronic Renal Failure Patients
Appendix 1
Adopted from the world Health Organisation and Hand Hygiene Australia
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