Hepatitis B - Management of At-Risk Newborn Infants

Publication: 01/01/2002  --
Last review: 01/08/2017  
Next review: 01/08/2020  
Standard Operating Procedure
ID: 272 
Supported by: Head of Nursing for Professional Practice, Clinical Standards & Patient Safety
Approved By:  
Copyright© Leeds Teaching Hospitals NHS Trust 2017  


This Standard Operating Procedure is intended for use by healthcare professionals within Leeds unless otherwise stated.
For healthcare professionals in other trusts, please ensure that you consult relevant local and national guidance.

Hepatitis B - management of at-risk newborn infants

Summary of Guideline

Infants born to Hepatitis B infected mothers are at high risk of vertical transmission and this confers a high risk of becoming chronically infected with the virus. The risk is highest (70-90% when the mother is e-antigen positive or highly viraemic, the risk is lower (10%) in HBeAg-negative mothers who have chronic Hepatitis B infection.

Mothers in the UK are screened for Hepatitis B in early pregnancy. This guideline outlines the actions to be taken in infants born to Hepatitis B infected mothers (HBsAg +ve) depending on the results of the maternal screening test.

This guideline also considers those infants at risk due to parental drug use (pre-exposure prophylaxis) 

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All women are offered Hepatitis B screening in early pregnancy. This screen consists of testing for the Hepatitis B surface antigen (HBsAg) and in those who are positive, anti-HBe antibodies (anti-HBe) and Hbe antigen (HBeAg). Anti-HBc IgM is performed to rule out recent infection.

Women who are HBsAg positive have chronic Hepatitis B infection and are at risk of transmitting virus to their baby at the time of delivery. This risk can be prevented in 90% by prompt administration of appropriate vaccine. These women will be known to the Screening coordinator midwife (Alison Perry or Odile Poole) who will alert the neonatal team at delivery and ensure vaccine is available. Unbooked mothers presenting in labour should have an HBsAg test performed within 24 hours of delivery so that the baby may be vaccinated if necessary.

The routine childhood immunisation schedule gives pre-exposure protection against hepatitis B which will benefit those who may have future risk of exposure to it. High risk infants such as infants born to HepB positive mothers, will require additional vaccination prior to commencement of the routine schedule.

Mothers who have cleared their Hepatitis B infection or who have received immunisation against Hepatitis B will have anti-HBs antibodies and their babies are not at risk and do not require earlier immunisation but will still get routine immunisation.

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Is this infant at risk of Hepatitis B infection?

All infants born to HepBsAg +ve mothers require vaccination. In addition those at high risk require Hepatitis B immunoglobulin. Babies who will be discharged to a household where there are known substance misusers should also be offered vaccination. The following table identifies those patients at risk and the action required.

Maternal status



Hepatitis B immune (anti HBs antibody positive, HBsAg negative)

Previous vaccination or cleared infection

No action needed

Acute Hepatitis B infection in pregnancy

High risk

Vaccine & Immunoglobulin

HBsAg +ve

HBeAg +ve

High risk

Vaccine & Immunoglobulin

HBsAg +ve

HBeAg -ve, but antiHBe -ve

High risk

Vaccine & Immunoglobulin

HBsAg +ve

No information about e-markers

Assume high risk

Vaccine & Immunoglobulin

HBsAg +ve

HBV DNA viral load > 1x106 IUs/ml pregnancy*

High risk

Vaccine & Immunoglobulin

HBsAg +ve

Birthweight <1500g (regardless of e-antigen status)

Increased risk

Vaccine & Immunoglobulin

HBsAg +ve

HBeAg -ve and anti-HBe antibody positive

Lower risk

Vaccine only

* Quantitative Hepatitis B DNA PCR is now performed in all HBsAG positive mothers to inform maternal treatment. Note that viral load of less than 1x106 IUs/ml, (in the absence of other high risk factors) is NOT an indication for immunoglobulin.

Special cases:

Babies <1500g

  • Babies <1500g born to mothers infected with Hepatitis B (HBsAg +ve) should receive immunoglobulin in addition to vaccination as they are at higher risk of vertical transmission, regardless of the e-marker status of the mother.
  • Preterm babies should receive the full paediatric dose of hepatitis B vaccine(see below) and should receive the vaccine at the appropriate chronological age as per the schedule (see below)
  • Preterm babies ≤28 weeks who are in hospital should have respiratory monitoring for 48 hours after vaccination. Those who experience apnoea/ bradycardia / desaturations after the first dose should have the second dose administered in hospital.

Infants of substance- misusing mothers / Household chronic carriers

  • Where a baby is being discharged to the care of a drug user the baby or where there is a known chronic carrier (including fathers) in the household, there may be a higher risk of environmental exposure to Hepatitis B and vaccination should be offered. It can be declined by maternal choice. If vaccinated a monovalent dose of hepatitis B vaccine should be offered before discharge from hospital, they should then continue on the routine childhood schedule commencing at eight weeks.

Infants born to Hepatitis B and HIV infected mothers

  • These infants should be managed according to the guideline above and the guideline “management of infants born to HIV positive mothers” detail.aspx?ID=177 There is no contraindication to Hepatitis B vaccine in these infants.

Infants who need BCG vaccination

  • There is no contraindication to administering Hepatitis B vaccine / immunoglobulin and BCG vaccine in the same patient at the same time. Ideally the BCG should be administered at the same time as the Hepatitis B vaccine.
  • Note: Inactivated vaccines such as hepatitis B do not interfere with the immune response to other inactivated vaccines or to live vaccines. An inactivated vaccine can be administered either simultaneously or at any time before or after a different inactivated vaccine or live vaccine. The immune response to one live-virus vaccine might be impaired if administered within 30 days of another live-virus vaccine. Live attenuated vaccines include measles, mumps, and rubella vaccine MMR and the BCG vaccine - see the latest version of the green book for further information.

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Investigations and further advice

  • Maternal Hepatitis B infection is not a contraindication to breastfeeding, provided the baby receives appropriate vaccine.
  • Babies born to Hepatitis B infected mothers do not need blood tests or other investigations at birth unless there are other clinical risk factors. Testing for HBsAg is recommended at 1 year of age. This is performed in the community paediatric clinic.

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Immunisation schedule

Hepatitis B vaccine
All newborn infants who require Hepatitis B vaccine (regardless of indication) should receive doses according to the following schedule. This offers life-long immunity.

Birth (within 24 hrs)

Monovalent HepB

4 weeks

Monovalent HepB

8 weeks

Infanrix Hexa
(as per routine schedule)

12 weeks

Infanrix Hexa
(as per routine schedule)

16 weeks

Infanrix Hexa
(as per routine schedule)

12 months

Monovalent HepB
(with HBsAg test and Anti HBs antibody level)

† Newborn infants born to a hepatitis B negative woman but known to be going home to a household with another hepatitis B infected person or into the care of a drug user may be at immediate risk of hepatitis B infection. In these situations, a monovalent dose of hepatitis B vaccine should be offered before discharge from hospital. They should then continue on the routine childhood schedule commencing at eight weeks.

The vaccine prescribed at LTHT is Engerix B Paediatric ® 10 micrograms intramuscular injection, into the thigh. This is a recombinant vaccine and causes no risk of infection.

For details of the schedule for babies born prior to 1st August 2017 please see the green book

Hepatitis B Immunoglobulin
This should be administered at the same time as the Hepatitis B vaccine, in the opposite thigh by i.m. injection. Dose= 200 international units. It should be administered within 24 hours of birth but does not need to be given urgently and is therefore best given during working hours when it can be discussed with the senior staff if any doubt as to whether indicated or not. Immunoglobulin is obtained from Public Health England and is ordered by Alison Perry / Odile Poole and placed in the fridge on the relevant delivery suite 6 weeks prior to the EDD. When required urgently it can be obtained from the Virology Department. This is a human blood product from screened donors outside the UK. As with any blood product there is a small risk of anaphylaxis. This is extremely unlikely in the newborn period.


  • Note the immunisation and batch number in the medical notes, on the prescription chart and in the parent held record (“Red Book”) if available.
  • Following vaccination send a “non-scheduled immunisation” form (A5 form, available on transitional care / neonatal unit) to David Lane, Senior Administrator, Child Health, St Mary’s Hospital, Leeds
  • For infants vaccinated because of maternal Hepatitis B infection we need to specifically inform the GP, (click here for Letter 1) .Subsequent doses in the community are coordinated by the midwife screening coordinator (Alison Perry), the Hepatitis B specialist health visitor and Child Health (David Lane)
  • For infants vaccinated due to maternal iv drug use, please send this letter to the GP [ click here- letter 2] and refer the baby to community paediatrics for further follow up (Dr Mandy Thomas / Dr Anna Gregory)
  • Administration of Hepatitis B Immunoglobulin (HBIG) requires a special notification form to be completed and sent to the Health Protection Agency: Note this is undertaken by Alison Perry/ Odile Poole. See: http://www.hpa.org.uk

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Record: 272


To prevent the vertical and environmental transmission of Hepatitis B infection.


  • To guide the identification of at risk infants based on maternal Hepatitis B screening results
  • To ensure the correct vaccination regime is instigated
  • To ensure high risk infants receive Hepatitis B immunoglobulin therapy
  • To ensure the correct notifications are made to child health
  • To ensure the correct follow up is arranged
Clinical condition:

Hepatitis B

Target patient group: Newborn Infants
Target professional group(s): Secondary Care Doctors
Secondary Care Nurses
Primary Care Doctors
Adapted from:


Evidence base

  1. Department of Health: Immunisation against Infectious Diseases (The ‘Green Book’). http://immunisation.dh.gov.uk/green-book-chapters/chapter-18/ (Updated, 17th July 2017, accessed July 2017) (level C evidence)
  2. Health Protection Agency. Policy on the use of passive immunisation with hepatitis B Immunoglobulin (HBIG) for infants born to Hepatitis B infected mothers. 2008. Accessed Nov 2017 via http://www.hpa.org.uk/webc/HPAwebFile/HPAweb_C/1223019399138 (level C evidence)
  3. BNFc 2017 http://www.medicinescomplete.com/mc/bnfc/current/PHP15337-immunological-products-and-vaccines.htm (level C evidence)
  4. CDC advice on co-administration of vaccines.

Document history

LHP version 1.0

Related information

Audit and monitoring compliance

Compliance with this guideline will be audited every three years. Audit results will be presented to the maternity / neonatal governance audit meeting, which will agree actions arising from the recommendations, and monitor the progress of the actions.

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Equity and Diversity

The Leeds Teaching Hospitals NHS Trust is committed to ensuring that the way that we provide services and the way we recruit and treat staff reflects individual needs, promotes equality and does not discriminate unfairly against any particular individual or group.