A clinical guideline recommended for use In: By: For: Key words: Written by: Supported by: Approved

by: Dr David Booth, Consultant Neonatologist Dr Margaret Sillis, Consultant Clinical Scientist, Virology Clinical Guidelines Assessment Panel (CGAP) Clinical Effectiveness Committee Reported as approved Clinical Governance Committee to the: Healthcare Governance Board Date of approval Nov 2007 Date 21 Nov 2007 Delivery Suite, Blakeney Ward, NICU, Cley Ward Paediatric medical and nursing staff and midwifery staff For Infants at risk of Hepatitis B infection Hepatitis B, Neonates, Infants Dr Jayanti Bose, SpR Neonatal Medicine

To be reviewed before: Nov 2010 To be reviewed by: Dr David Booth, Consultant Neonatologist

Guideline supersedes: CA2017 V1 Guideline Reg. No: CA2017 V2

Document

Immunisation of infants at risk of Hepatitis B infection

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Trust Guideline for the Immunisation of Infants at Risk of Hepatitis B Infection Quick reference guideline
Term Infants Hepatitis B status of mother HBsAg positive and HBeAg positive HBsAg positive, HBeAg negative, anti-HBe negative HBsAg positive where e markers not determined Acute hepatitis B during pregnancy HBsAg positive , anti-HBe positive Baby should receive Hepatitis B vaccine HBIG single dose Yes Yes Yes Yes Yes Yes Yes Yes Yes No

Dosage As soon as possible (within 24 hours) after birth Hepatitis B vaccine HBIG 0.5mL* 200 iu IM IM anterolateral aspect of thigh anterolateral aspect of thigh (contralateral thigh to vaccine)

*There are two brands of Hepatitis B (Hep B) vaccine available: Pharmacy usually stock Engerix B (dose 10 micrograms in 0.5mL). When there are supply problems, we use HBvaxPRO (dose 5 micrograms in 0.5mL). The dose of vaccine administered varies with brand, but the volume administered is 0.5mL, regardless of brand. Very low birth weight infants (1500g or less) Both vaccine and HBIG should be given to infants of Hepatitis B-infected mothers regardless of the e antigen/antibody status of the mother. Preterm infants Preterm infants of Hepatitis B-infected mothers should receive full term infant dose of Hepatitis B vaccine. Abbreviations: HBV and Hep B: HBIG: HBsAg: HBeAg: anti-HBe: IM

Hepatitis B virus Hepatitis B immunoglobulin Hepatitis B virus surface antigen Hepatitis B virus e-antigen antibodies against Hepatitis B e-antigen intramuscular

Author/s Dr Bose Dr Booth Valid until November 2010 Document Immunisation of infants at risk of Hepatitis B infection Copy of complete document available from Trust Intranet

Date of issue November 2007 Guideline Ref No CA2017 version 2 Page 2 of 8

Trust Guideline for the Immunisation of Infants at Risk of Hepatitis B Infection 2. 3.

Objective of guideline
To immunise those infants at risk of infection with Hepatitis B virus

Rationale for the recommendations

Perinatal transmission of maternal HBV infection accounts for up to 50% of cases of chronic hepatitis B carriage. Since April 2000, screening for HBV has been routinely offered to all women in early pregnancy. This aims to identify infants at risk of Hepatitis B infection Risk of vertical transmission of the virus is associated with the e-antigen status of the mother Perinatal transmission of HBV can be reduced by immunisation of the infant - a recent Cochrane Review concludes that vaccine, Hepatitis B immunoglobulin (HBIG), and vaccine plus Hepatitis B immunoglobulin prevent Hepatitis B occurrence in newborn infants of Hepatitis B surface antigen (HBsAg) positive mothers.1 Low birth weight infants weighing <1500g should receive both Hepatitis B vaccine and Hepatitis B immunoglobulin regardless of the e-antigen status.2, 3 Preterm infants should receive the full paediatric dose of Hepatitis B vaccine4

4.

Broad recommendations
To identify infants at risk of HBV infection and offer immunisation in the form of: vaccination alone or vaccination plus additional passive immunisation with Hepatitis immunoglobulin (HBIG) depending on the risk category (see below) B

5.

Clinical audit standards derived from guideline

All infants at risk of HBV identified All at risk infants offered immunisation Immunisation within the recommended time frame Correct documentation and timely communication of immunisation status

6.

Summary of development and consultation process undertaken before registration and dissemination
The authors listed above drafted the guideline. During its development it was reviewed at the neonatal unit guideline development meeting and amended based on recommendations arising from that forum. This version is endorsed by the Department of Microbiology at NNUH.

7.

Distribution list/ dissemination method

NICU Delivery Suite Blakeney Ward Cley Ward Trust Intranet

8.

References/ source documents

Date of issue November 2007 Guideline Ref No CA2017 version 2 Page 3 of 8

Author/s Dr Bose Dr Booth Valid until November 2010 Document Immunisation of infants at risk of Hepatitis B infection Copy of complete document available from Trust Intranet

Trust Guideline for the Immunisation of Infants at Risk of Hepatitis B Infection

Lee et al The Cochrane Database of Systematic Reviews 2006 Issue 2 Losonsky et al Pediatrics 1999; 103 (2): E14 Immunisation against infectious disease: Dept of Health 2006 The Green Bookhttp://www.dh.gov.uk/en/Policyandguidance/Healthandsocialcaretopics/Gre enbook/DH_4097254 4. Saari et al Pediatrics 2003; 112; 193-198
1. 2. 3.

Antenatal Management The neonatal unit should be notified via the Paediatric Alert system when antenatal screening serology has identified a woman infected with Hepatitis B virus. There is a separate Trust guideline Hepatitis screening in pregnancy and neonatal vaccination CA 3051 which outlines antenatal management in detail.
http://intranet/guidelines/Word%20docs/CA3051_Hepatits_%20B_Screening_ %20in_Pregnancy_and_Neonatal_Vaccination.doc

Post natal management Immunisation of infants The following protocol describes the immunisation strategy for term infants of mothers infected with Hepatitis B. Immunisation should occur as soon as possible (within 24 hours). Term infants Hepatitis B status of mother HBsAg positive and HBeAg positive HBsAg positive, HBeAg negative, anti-HBe negative HBsAg positive where e markers not determined Acute hepatitis during pregnancy HBsAg positive , anti-HBe positive Baby should receive Hep B vaccine HBIG single dose Yes Yes Yes Yes Yes Yes Yes Yes Yes No

Very low birth weight infants 1500g or less Both vaccine and HBIG should be given to infants of Hepatitis B-infected mothers regardless of the e antigen/ antibody status of mother. Preterm infants Preterm infants of Hepatitis B-infected mothers should receive full paediatric dose of Hepatitis B vaccine, according to above. Hepatitis B Immunoglobulin (HBIG) Is available via the Department of Microbiology, on a named patient basis only. HBIG is also available in an emergency from Pharmacy, but only if authorised by the Duty Virologist (ext: 4588) or, if out of hours, by the Consultant Microbiologist on call (via NNUH switchboard).

Author/s Dr Bose Dr Booth Valid until November 2010 Document Immunisation of infants at risk of Hepatitis B infection Copy of complete document available from Trust Intranet

Date of issue November 2007 Guideline Ref No CA2017 version 2 Page 4 of 8

Trust Guideline for the Immunisation of Infants at Risk of Hepatitis B Infection

At Risk Babies Other babies born at risk will be offered Hepatitis B immunisation these should include babies born to:

1. Primary caregiver(s) with a history of current or previous substance abuse e.g.

heroin, crack cocaine 2. Primary caregiver(s) on Methadone Programme 3. Human immunodeficiency virus (HIV) positive mothers 4. Hepatitis C Virus (HCV) positive mothers 5. Mothers from high HBV prevalence area with unknown HBV status (a country has high prevalence if the chronic infection rate is >8%. http://www.medic8.com/travel/viral-hepatitis-b.htm Schedule Infants at risk of infection should receive Hepatitis B vaccine at birth, 1 month, 2 months and at 12 months of age. Dosage At birth Hepatitis B vaccine 0.5mL IM anterolateral aspect of thigh HBIG 200 iu IM anterolateral aspect of thigh (if required) Contralateral thigh if vaccine given. 1 month 2 months 12 months Vaccines available Engerix B HBvaxPRO (dose 10 micrograms in 0.5mL). (dose 5 micrograms in 0.5mL). Hepatitis B vaccine 0.5mL IM anterolateral aspect of thigh Hepatitis B vaccine 0.5mL IM anterolateral aspect of thigh, can be at the same time as the first routine immunisation. Hepatitis B vaccine 0.5mL IM anterolateral aspect of thigh

The dose of vaccine administered varies with brand, but the volume administered is 0.5mL, regardless of brand. Documentation 1. Neonatal Hepatitis B Immunisation Form should be completed for each immunisation (see Appendix): Original to be filed in infants medical case notes 1 copy to be faxed to Norfolk Health Protection Agency (confidential fax no: 01603 307111) 1 copy to GP at time of discharge 1 copy for parents, to keep in the Red Book at time of discharge
Author/s Dr Bose Dr Booth Valid until November 2010 Document Immunisation of infants at risk of Hepatitis B infection Copy of complete document available from Trust Intranet Date of issue November 2007 Guideline Ref No CA2017 version 2 Page 5 of 8

Trust Guideline for the Immunisation of Infants at Risk of Hepatitis B Infection

1. In addition, there is a special insert for the parent held child health record (red book) on which to record the immunisation for Hepatitis B virus. These are available from the ward clerk on the neonatal unit Form 11a: Hepatitis B Infant Immunisation Programme. Follow up 1. Testing for HBsAg at one year of age will identify babies for whom this intervention has not been successful and who have become carriers and will allow them to be referred for assessment and any further management.

2. This testing can be carried out concurrent with administration of the 4th dose of vaccine.
3. Where immunisation is delayed beyond the recommended intervals the vaccine course should be completed, but it is more likely that the child may become infected. In this instance testing for HBsAg above the age of 12 months is particularly important.

4. Follow up is the responsibility of the infants GP. A plan outlining follow up should be
included with the infants discharge documentation and sent to the GP.

Author/s Dr Bose Dr Booth Valid until November 2010 Document Immunisation of infants at risk of Hepatitis B infection Copy of complete document available from Trust Intranet

Date of issue November 2007 Guideline Ref No CA2017 version 2 Page 6 of 8

Trust Guideline for the Immunisation of Infants at Risk of Hepatitis B Infection

Author/s Dr Bose Dr Booth Valid until November 2010 Document Immunisation of infants at risk of Hepatitis B infection Copy of complete document available from Trust Intranet

Date of issue November 2007 Guideline Ref No CA2017 version 2 Page 7 of 8

APPENDIX

Neonatal Intensive Care Unit Norfolk & Norwich University Hospital Colney Lane Norwich NR4 7FP

Neonatal Hepatitis B Immunisation

Infants ID Label (including address)

Name of Mother: .. Maternal DOB:

Consent

I confirm that I have parental responsibility for the above-named infant I agree for my infant to receive Hepatitis B immunisation The procedure has been explained to me by medical/nursing staff

Parents name...SignatureDate.. Consent taken by (Name) Grade.Signed...................

First Hepatitis B Immunisation/s (within 24 hours of

Vaccine Hep B vaccine HBIG
IF REQUIRED*

Batch No.
(use sticker)

Dose/Route

Date Given & Site

Given By
(print name & sign)

0.5 mL/IM 200 iU/IM

Opposite thigh

Documented in Red Book

Copy faxed to Norfolk HPA: 01603 307111

Second Hepatitis B Immunisation (at age 1 month) (given by GP if no longer in-patient) Vaccine Batch No. Dose/Route Date Given & Site Given By
(print name & sign)

Hep B vaccine Documented in Red Book

0.5 mL/IM
Copy faxed to Norfolk HPA: 01603 307111

Third Hepatitis B Immunisation (at age 2 months) Vaccine

Hep B vaccine Documented in Red Book

(given by GP if no longer in-patient)

Batch No.

Dose/Route 0.5 mL/IM

Date Given & Site

Given By
(print name & sign)

Copy faxed to Norfolk HPA: 01603 307111

(Fourth Hepatitis B immunisation to be given by GP at 12 months of age) AT DISCHARGE:

Document

Send copy of this form to:

(File original in casenotes)

GP

Parents
(put in Red Book)
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Immunisation of infants at risk of Hepatitis B infection