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Engerix-B

Common name:

Hepatitis B, hep B

Protects against hepatitis B.

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Overview

Hepatitis B vaccine is delivered on the universal immunisation schedule as part of Infanrix®-hexa vaccine delivered at 6 weeks, 3 months and 5 months. No further doses are required.

  • Engerix®-B 20mcg is the funded hepatitis B vaccine for: 
    • Adults aged 20 years or older who meet the 'special groups' eligibility criteria.
    • 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.
  • HBvaxPRO® 5mcg for eligible infants, children and adolescents and HBvaxPRO and 40mcg for adults aged 18 years or older who are on renal dialysis or who are liver or kidney transplant patients are in stock.

Responses to vaccine

Engerix-B (hep B)

Common Responses

  • Mild pain, redness and swelling around injection site
  • Irritability
  • Decreased appetite
  • Nausea, vomiting, abdominal pain, or diarrhoea

Rare Responses

  • Hives
  • Itching
  • Muscle or joint pain

As with any medicine, very rarely a severe allergic reaction (anaphylaxis) can occur following immunisation.

References

In Depth

Other brands:

Other brands that contain hepatitis B vaccine:

  • (DTaP-IPV-Hib/HepB combination) Infanrix®-hexa
  • HBvaxPRO® 5mcg and 40mcg
  • (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.

  • Engerix®-B 20mcg is currently the funded hepatitis B vaccine for: 
    • Adults aged 20 years or older who meet the 'special groups' eligibility criteria.
    • 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.
  • HBvaxPRO® 5mcg is in stock for infants, children and adolescents.
  • HBvaxPRO 40mcg is in stock and is funded for adults aged 18 years or older who are on renal dialysis or who are liver or kidney transplant patients. 

Administration

  • The vaccine is administered by intramuscular injection in the deltoid in adults.
  • Adults due to receive HBvaxPRO 10mcg doses receive Engerix-B 20mcg/mL doses. 
  • 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. 

  • 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 5mcg is in stock for infants, children and adolescents.
  • HBvaxPRO 40mcg schedule for adults aged 18 years or older who are on renal dialysis or who are liver or kidney transplant patients.

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

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

    HBvaxPRO 40mcg/mL is available and funded for:

    • 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

      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

      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

      Last updated: Jan 2019