Engerix-B 10 mcg and Engerix-B 20 mcg are the funded hepatitis B vaccines for:

• Infants born to mothers who are hepatitis B positive,
• Infants, children and adolescents aged under 18 years who require doses of hepatitis B vaccine, and
• Adults aged 18 years or older who meet 'special groups' eligibility criteria.

Protecting at-risk newborns from hepatitis B

Infants born to mothers who are hepatitis B positive are at a very high risk of developing chronic hepatitis B infection, which can result in liver failure and cancer later in life as well as infecting others. Therefore, hepatitis B vaccine is given to newborn babies whose mothers are hepatitis B-positive, at the same time as hepatitis B immunoglobulin (HBIG), to reduce the risk of having been infected with hepatitis B virus during the birth process. Hepatitis B vaccination plus HBIG protects infants from hepatitis B infection significantly better than immunoglobulin alone.

Paediatric hepatitis B vaccination

Engerix-B dose options from the data sheet and Immunisation Handbook 2020

   Infants born to mothers who are hepatitis B positive

• 1 x 10 mcg at birth (a 20 mcg /1.0 mL vaccine can be substituted for this dose if the 10 mcg/0.5 mL vaccine is not available)

   0–10 years

• 3 x 10 mcg at 0, 1 and 6 months (a 20 mcg /1.0 mL vaccine can be substituted for any of these doses if the 10 mcg/0.5 mL vaccine is not available)

   11–15 years

• 3 x 20 mcg at 0, 1 and 6 months, or
• 2 x 20 mcg at 0 and 6 months*

        *Not in Engerix-B data sheet, but is advised in Handbook based on interchangeability of          hepatitis B vaccines and the adolescent hepatitis B vaccination for those aged 11-15 years of two          adult hepatitis B vaccine doses (a minimum of four months apart; but preferably six).

   16–18 years

• 3 x 20 mcg at 0, 1 and 6 months

Adult funded hepatitis B vaccination ‍

   Special groups 18+ years ‍

   Immunocompetent

• 3 x 20 mcg at 0, 1 and 6 months
• If a compressed schedule is required 3x 20mcg at 0, 1, and 2 months then an additional dose (20mcg) should be given at 12 months from the first dose to give longevity of response as per datasheet
• The rapid schedule outlined in the Engerix-B data sheet (0, 7, 21 days, 12 months from the first dose) is only recommended in exceptional circumstances, e.g. travellers starting their vaccine course within one month of their departure.  

   Immunocompromised

• 3 x 20 mcg at 0, 1, 6 months

   Dialysis and liver/kidney transplant patients

• 2x 20 mcg vaccine doses co-administered to make up 40mcg x 3 at 0, 1, 6 months
• On specialist advice, other schedules may be considered

Adult non-funded/purchased hepatitis B  vaccination

• 3 x 20 mcg at 0, 1 and 6 months
• If a compressed schedule is required 3x 20mcg at 0, 1, and 2 months then an additional dose (20mcg) should be given at 12 months from the first dose to give longevity of response as per datasheet.
• The rapid schedule outlined in the Engerix-B data sheet (0, 7, 21 days, 12 months from the first dose) is only recommended in exceptional circumstances, e.g. travellers starting their vaccine course within one month of their departure.

Catch-up hepatitis B vaccination

See Appendix 2 in the current Immunisation Handbook for further details on catch-up schedules and doses.

Administration

• Infants born to HBsAg positive mothers receive a single dose of Engerix-B 10mcg mcg at or within 12 hours of delivery. These infants then receive three hepatitis B containing vaccines as per the National Immunisation Schedule.
• The vaccine is administered by intramuscular injection in the vastus lateralis in infants and young children, and the deltoid in older children and adults.
• Adults due to receive a 40mcg dose receive two Engerix-B 20mcg/mL doses administered at the same visit using different sites.
• Engerix-B can be administered concurrently with other vaccines, including all the National Immunisation Schedule vaccines. Separate syringes and different injection sites should be used.

Recording two coadministered doses of Energix-B 20mcg

• Order two doses of Engerix-B 20 mcg/mL for one 40mcg dose
• Administer two doses of Engerix-B 20mcg/mL at the same visit using separate injection sites.
• Record the vaccination in the PMS immunisation section by selecting the DLK eligibility and recording the batch number, expiry date and injection site used for one dose and writing "Engerix-B 20mcg x 2 given" in the note section.
• Record the vaccination in the PMS clinical notes, explain that two Engerix-B 20mcg doses were co-administered because a single 40mcg dose was not available, record the details of both injection sites and, if they are different, both vaccine batch numbers and/or expiry dates.

Where to order Engerix-B

• Engerix-B for funded adults is available from ProPharma.
• Engerix-B for adults who are not eligible for funded hepatitis B vaccine but for whom hepatitis B vaccine is recommended is available from Healthcare Logistics.

Testing for hepatitis B immunity

Generally a serology result of ≥10 IU/L (or ≥20 IU/L for high risk individuals, depending on laboratory used) is considered immunity to hepatitis B. Vaccinated individuals who have laboratory confirmation of anti-HBs ≥10 IU/L are considered to have lifetime immunity to hepatitis B even if antibody levels wane to undetectable levels in subsequent serology. This is because an anamnestic immune response will be protective against future hepatitis B exposure.

Refer to the current Immunisation Handbook for information on post-vaccination serology testing and management of non-responders. Non-responders require case-by-case consideration.

Special groups

Adults aged 18 years or older who meet the 'special groups' eligibility criteria:

• Household or sexual contacts of a known acute hepatitis B case or hepatitis B carrier
• Individuals who are HIV-positive
• Individuals who are hepatitis C positive
• Solid organ transplant patients (for liver or kidney transplant patients, refer below)
• Individuals post-haematopoietic stem cell transplant (HSCT)
• Following immunosuppression due to steroid or other immunosuppressive therapy longer than 28 days
• Non-consensual sexual intercourse
• Needle stick injury

Two doses of Engerix-B 20 mcg administered at the same visit to deliver a 40mcg equivalent dose:

• Adults aged 18 years or older who are on renal dialysis or who are liver or kidney transplant patients.

Hepatitis B vaccine is recommended and may be funded by an employer for those at occupational risk of being infected with hepatitis B through contact with blood or bodily fluids e.g.:

• Health professionals: dentists, doctors, nurses, midwives, laboratory staff and students in training for these occupations
• Allied healthcare staff who come into contact with bodily fluids and blood - healthcare assistants, care workers in residential and non-residential facilities, morticians and funeral workers, hospital orderlies
• Emergency service personnel
• Members of the armed forces
• Correctional facility staff
• Sex industry workers
• Tattooists and body piercers

In addition to occupational groups, the Engerix-B vaccine is also recommended but not funded for the follow groups who are at risk of infection:

• Adults with severe kidney disease who may require dialysis in the future
• Those expecting to receive a solid organ or bone marrow transplant if they are not already protected against hepatitis B
• People with chronic liver disease or who are at risk of developing chronic liver disease, e.g. people who misuse alcohol
• Recipients of blood products, such as factor VIII
• Migrants from and travellers to hepatitis B endemic countries
• People with developmental disabilities
• Inmates of correctional facilities
• Adults at risk of infection through sexual exposure, including men who have sex with men and individuals being treated for other sexually transmitted diseases.
• Injecting drug users

Storage and preparation

• Store as per cold chain between 2°C to 8°C.
• Engerix-B does not contain preservative.

Engerix-B should not be given to:

• Anyone with severe allergy (anaphylaxis) to a previous dose of this vaccine or other hepatitis B containing vaccine, or a component of the vaccine
• Administration of hepatitis B vaccine should be postponed in individuals suffering from a fever over 38°C. The presence of a minor infection is not a reason to delay immunisation.

Specialist advice should be sought for the following groups:

Those with bleeding disorders, such as haemophilia. The vaccine should be administered in accordance with the haematologist’s instructions. It may, in this situation only, be given subcutaneously. An increased incidence of local reactions including subcutaneous nodules has been observed with this method.

It is safe to give during pregnancy if the woman is non-immune to hepatitis B and has had sexual or household contact with a hepatitis B infected person. Engerix-B can safely be given when breastfeeding.

The response to Engerix-B varies with age. After a course of three Engerix-B vaccine doses 89-96% of healthy individuals were protected from hepatitis B.

Immune memory from recombinant hepatitis B vaccines against clinical disease and chronic hepatitis B infection remains for at least 15-20 years when given to health individuals fully immunised as infants. Cellular immunity appears to remain even when antibody levels decline below detectable levels.

A study of recombinant hepatitis B vaccine recipients 15-16 years earlier, including several whose antibody levels were <10 mIU/mL, demonstrated an anamnestic antibody response to a booster/challenge dose of hepatitis B vaccine. Routine measurement of hepatitis B antibodies post-vaccination is not recommended. The exception would be when the vaccinee may be at increased risk and evidence of seroconversion is required. Serology should be done four weeks after the third vaccine dose

• Medsafe. New Zealand data sheet: Engerix-B [Internet]. Wellington: New Zealand Medicines and Medical Devices Safety Authority; 1988 [updated 2020 August 11; cited 2020 November 13]. Available from: http://www.medsafe.govt.nz/profs/Datasheet/e/Engerix-Binj.pdf
• Ministry of Health. Immunisation handbook [Internet]. Wellington: Ministry of Health; 2020 [updated 2020 September 25; cited 2020 September 28]. Available from: https://www.health.govt.nz/publication/immunisation-handbook-2020
• The Hepatitis Foundation of New Zealand http://www.hepatitisfoundation.org.nz/
• Van der Meeren O, Behre U and Crasta P. mmunity to hepatitis B persists in adolescents 15–16 years of age vaccinated in infancy with three doses of hepatitis B vaccine. Vaccine 2016 34 (24) 2745-2749.