Guideline and Procedure Title and Document No.
Guideline and
Procedure
Hepatitis B vaccination regime for adult chronic renal failure
patients
Sites where Guideline and Procedure
applies
Target audience:
Description
This Guideline and Procedure applies to:
1. Adults
2. Children up to 16 years
3. Neonates – less than 29 days
All HNE facilities where a patient receives hemodialysis
Nephrology clinical staff who provide care to hemodialysis
patients
Yes
Yes
No
Keywords
Hepatitis B, Vaccination
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Superseded Documents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 require 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 applicable
Guideline and Procedure and committee) with authority to authorise
authorised by
Contact Person
Tina Straker
Contact Details
02 67769912
Date authorised
This Guideline and
Yes/No (delete)
Procedure contains advice
(If Yes) Approval gained from HNE Quality Use of Medicines Committee
on therapeutics
on (insert date)
Date of Issue
Review due date
TRIM Number
Version Number
Month and Year
Guideline and Procedure Title and Document No.
1. Targeted consultation – Consultation was obtained across the Area Renal network including
Nephrologists, Chronic Kidney Disease and Dialysis Nursing staff, consultation also occurred with
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 HD patients because of depressed immunity in renal
failure.1–3 Malnutrition,4,5 malignancies, IV iron overload, hepatitis C infection6 inadequate
dialysis, use of low-biocompatible material, hyperparathyroidism, anemia and old age7 are all
factors contributing to altered immunity. Therefore, different strategies have been proposed to
improve the response rate in hemodialysis patients: reinforced intramuscular (IM / / intradermal
(ID) schedule (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 Where possible, abbreviations should be avoided. Please List
all Abbreviations used in the Guideline and Procedure here in alphabetical order (add extra lines to
table if needed).
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.
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Guideline and Procedure Title and Document No.
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.
Intradermal administration is also an option of vaccination if the patient does not seroconvert.
Pre- Dialysis Patients- Following referral from nephrologist to the pre dialysis pathway virology is
arranged by the Pre Dialysis Coordinator. If immunity not detected a prescription for Hepatitis B
vaccine is organised. The patient is to collect script and arrange for their GP to administer. Patients
are to inform Coordinator at commencement of vaccine regime.
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.
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 of current Hepatitis B vaccine currently available. Vaccines are to be given at
0, 1 and 6 months.
2.
Current doses are recommended
3.
0 months- 40 microgram/mL via IMI injection
4.
1 months- 40 microgram/mL
5.
6 months- 40 microgram/mL
6.
4 to 8 weeks following 3rd vaccination serology should be attended to determine immunity
7.
If Hepatitis B surface antibody falls below recommended levels (>10) or shows poor
seroconversion after initial immunization regime a single booster can also be offered.
Administration of IM Injection:
• Patients receiving anticoagulant therapy during dialysis should have the vaccine administered 30
minutes prior to dialysis (for IMI).
• Check patient, order and vaccine dose and expiry date.
• Explain the procedure to the patient and obtain consent and provide with consumer product
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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 six weeks after the last
injection. A 4th dose may be required, if the anti-HBs <10 IU/L.
• If the Anti-HBs IU/L is still <10 following booster vaccination, it is advisable to proceed with IntraDermal 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 there are less likely to be complications
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 will 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 Intra-Dermal
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 six weeks after the last
injection. If antibody titre continues to be <10 IU/L, the notes should reflect that the patient is an ID
Hepatitis B non-responder and no further Hepatitis B vaccination undertaken
APPENDICES
Five Moments of Hand Hygiene
REFERENCES
Australia Immunisation Handbook 9th Edition, Section 3.6 Hepatitis B
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
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Guideline and Procedure Title and Document No.
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
Author, (Date). Title of Publication, Place Published: Published by Whom
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