Other brands:
- Engerix®-B
- Other brands that contain hepatitis B vaccine
- (DTaP-IPV-Hib/HepB combination) Infanrix®-hexa
- (In combination with Hepatitis A) Twinrix®, Twinrix® Junior
Vaccine type: subunit, recombinant
Schedule and administration
Hepatitis B vaccine is administered to children on the National Immunisation schedule at 6 weeks, 3 and 5 months as part of Infanrix-hexa vaccine.
- HBvaxPRO® 5mcg vaccine is in stock for infants, children and adolescents.
- HBvaxPRO 10mcg vaccine is out of stock. Stock is not expected to be available until later in 2019.
- Engerix®-B 20mcg is the funded hepatitis B vaccine for:
- Adolescents aged 11–15 years following the two-dose schedule, with the second dose given 4–6 months after the first, and
- Adults aged 20 years or older who meet the 'special groups' eligibility criteria.
- HBvaxPRO® 40mcg vaccine is out of stock in some areas
- Two doses of Engerix-B 20 mcg administered at the same visit replace one dose of HBvaxPRO 40mcgwhen this vaccine is out of stock as the funded hepatitis B vaccine for:
- Adults aged 18 years or older who are on renal dialysis or who are liver or kidney transplant patients.
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.
Administration
- The vaccine is administered by intramuscular injection in the vastus lateralis in infants and young children and in the deltoid in older children, adolescents and adults.
- Infants born to HBsAg positive mothers receive a single dose of HBvaxPRO 5mcg at or within 12 hours of delivery. These infants then receive three hepatitis B containing vaccines as per the National Immunisation Schedule.
- Infants, children and adolescents receive HBvaxPRO 5mcg doses.
- Adults due to receive HBvaxPRO 10mcg receive Engerix-B 20mcg/mL.
- Adults due to receive HBvaxPRO 40mcg receive two Engerix-B 20mcg/mL doses administered at the same visit using separate sites when HBvaxPRO 40mcg is out of stock.
- Engerix-B and HBvaxPRO can be administered concurrently with other vaccines, including all the National Immunisation Schedule vaccines. Separate syringes and different injection sites should be used.
Catch-up doses
NOTE: The rapid schedule outlined in the Engerix-B data sheet (0, 7, 21 days, 12 months from the third dose) is not used for individuals eligible to receive funded Engerix-B vaccine. The rapid schedule is only recommended in exceptional circumstances, e.g. travellers starting their vaccine course within one month of their departure.
- HBvaxPRO 5mcg is in stock for infants, children and adolescents aged under 20 years.
- Engerix-B 20mcg schedule for individuals who are not HIV-positive or immunosuppressed: doses spaced at 0, 1 and 2 months after dose 1 for all age groups, i.e. a minimum interval of 4 weeks between each dose#. A fourth hepatitis B vaccine dose is not required when this schedule is followed.
- Engerix-B 20mcg schedule for HIV-positive: 0, 1, 2 and 12 months after dose 3.
- Engerix-B 20mcg schedule for immunosuppressed: 0, 1 month and 6 months (after first dose).
- HBvaxPRO 40mcg or two coadministered doses of Engerix-B 20mcg schedule for adults aged 18 years or older who are on renal dialysis or who are liver or kidney transplant patients: 0, 1 and 2 months (after first dose) or 0, 1 and 6 months (after dirst dose).
See Appendix 2 in the current Immunisation Handbook for further details on catch-up schedules and doses.
Recording two coadministered doses of Energix-B 20mcg when HBvaxPRO 40mcg is out of stock
If HBvaxPRO 40mcg is out of stock in your area:
- Order two doses of Engerix-B 20 mcg/mL to replace one HBvaxPRO 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 HBvaxPRO 40mcg was out of stock, record the details of both injection sites and, if they are different, both vaccine batch numbers and/or expiry dates.
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
HBvaxPRO® 5mcg is in stock for:
- Infants born to a mother who is hepatitis B surface antigen (HBsAg) positive
- Children and young adults aged under 18 years, to catch-up missed doses of vaccine, or who are considered not to have achieved a positive serology and require additional vaccination
- Adults aged 18–19 years who meet the 'special groups' eligibility:
- 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
Engerix-B 20mcg/mL currently replaces funded HBvaxPRO® 10mcg for:
- Adults aged 20 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 coadministered doses of Engerix-B 20mcg/mL replace one dose of HBvaxPRO 40mcg/mL when HBvaxPRO 40mcg is out of stock for:
- Adults aged 18 years or older who are on renal dialysis or who are liver or kidney transplant patients.
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.
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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
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.
Storage and preparation
- Store as per cold chain between 2°C to 8°C.
- Neither Engerix-B nor HBvaxPRO contain preservative.
Vaccine safety
Engerix-B and HBvaxPRO 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 and HBvaxPRO can safely be given when breastfeeding.
Vaccine effectiveness
Significantly fewer infants of HBsAg-positive mothers, who were given hepatitis B vaccine plus hepatitis B immunoglobulin at birth and completed their three dose primary hepatitis B vaccine course, acquired chronic hepatitis B infection when compared with historical controls who received only hepatitis B immunoglobulin at birth.
The response to Engerix-B and HBvaxPRO varies with age. After a course of three Engerix-B vaccine doses 89-96% of healthy individuas were protected from hepatitis B. After a course of three HBvaxPRO vaccine doses 99% of adolescents 11-19 years of age, 98% of young adults 20-29 years of age, 94% of adults 30-39 years of age, and 89% of adults > 40 years of age 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.
