Hepatitis B vaccine | Prescribing information | Hepatitis B | CKS | NICE (2024)

• There are several hepatitisB vaccines licensed for use in the UK, all of which are inactivated:
  • EngerixB^®.
  • Fendrix^®.
  • HBvaxPRO^®.
• Combined hepatitis A and B vaccines, Twinrix^®and Ambirix^®, are also available and Infarix hexa® which also contains diphtheria, tetanus, polio, Hib, and tetanus.

[PHE, 2016; Joint Formulary Committee, 2019; PHE, 2022 Green Book Chapter 18 Hepatitis B]

• Different hepatitis B vaccines, doses, and primary dosing schedulesare recommended depending on the person's age and whether they are receiving haemodialysis. For further information, consult the BNF.
• For most adult and childhood risk groups, an accelerated schedule should be used, with vaccine usually given at zero, one and two months. An alternative schedule (usually) at zero, one and six months should only be used where rapid protection is not required and there is a high likelihood of compliance.
  • For information on vaccination schedule for babies born to women with hepatitis B,see Public Health England's information leaflet forInformation for GPs and practice nursesHepatitis B vaccine for at risk infants.
• People in certain risk groups (occupationally exposed, people with renal failure),should have their antibody titres checked one to four months after the completion of a primary course of vaccine.In all other people, antibody testing is not considered necessary.
  • It is preferable to achieve anti-HBs levels above 100mIU/ml, although levels of 10mIU/ml or more are generally acceptedto protect against infection.
  • People found to haveanti-HBs levels of 10 to 100mIU/ml should receive one additional dose of vaccine.
  • In immunocompetent individuals, once a response has been established, further assessment of antibody levels is not indicated.
  • In non-responders (people with antibody levels below 10mIU/ml), serology should be checked for past or current hepatitis B infection. Arepeat course of vaccine is recommended, followed by retesting of antibody levels one to four months after the second course.If there is still an inadequate response, these people will require immunoglobulin for protection if exposed to hepatitis B.
  • For people with chronic renal failure receiving haemodialysis, antibody levels should be monitored annually, and if they fall below 10mIU/ml, a booster dose of vaccine should be given if the person has previously responded. A booster should alsobe offered if travel to a high risk country is planned and it is more than one year since the last booster.
• Longer than recommended intervals between doses do not appear to reduce the final antibody level or efficacy. There is no need to repeat doses if the vaccination course is interrupted.
• Booster doses after the primary course are not routinely required for healthy, immunocompetent adults.
  • However, a booster may need to be administered following significant exposure if the exposure was from a HBsAg positive source and the last vaccine dose was administered over 1 year ago. If the exposure was non-significant and from a HBsAg negative source then no further HepB vaccine is required.
• Note: Consult UKHSA guidancewhere vaccine supply issues have been noted.

[Joint Formulary Committee, 2019; NaTHNac, 2019; PHE, 2022 Green Book Chapter 18 Hepatitis B]

• Hepatitis B vaccine should be offered to people with HIV who are at risk of infection, as they are more likely to contract hepatitis B and also to develop chronic infection.
  • Four doses at 0, 1, 2, and 6months are usually recommended.
  • If an unadjuvanted vaccine is being used (Engerix®, HBvaxPRO®) a high dose (40 µg) is recommended.If the adjuvanted vaccine (Fendrix®) is being used, the standard (20 µg) dose can be used.
  • An ultra-rapid vaccination course (three standard-doses given over 3 weeks) should only beconsidered in people with CD4 cell counts >500 cells/μL, where rapid protection is necessary, and/or where compliance with a more protracted course is considered unlikely. High dose vaccine is not recommended in these circ*mstances due to a lack of safety data.
• Measure antibodies to hepatitisB surface antigen (HBsAb) 4–8weeks after completion of the vaccination schedule.
  • If HBsAb is less than 10IU/L, offer the person three further vaccine doses (as described above) at monthly intervals.
    • Depending on the level of risk, re-vaccination may be delayed until the viral load is suppressed on ART and the CD4 cell count has increased >350 cells/μL.
    • Retesting for HBsAb is recommended 4–8weeks after the final dose of vaccine.
  • If HBsAb is greater than 10IU/L but less than 100IU/L, offer the person one additional dose of vaccine.
    • Check the response 4–8weeks later.
• Following successful immunization (HBsAb >10 IU/L after completion of a full vaccine course) the person should be offered regular HBsAb testing (using clinical judgement to determine frequency).
  • People with initial HBsAb levels >100 IU/L, CD4 cell counts >350 cells/μL, and viral load suppression on ART should be retested at least every 2–4years
  • Other people should receiveHBsAb testing on an annual basis.
  • A booster dose of vaccine should be offered if HBsAb levels have declined to less than 10IU/L.
• Further boosters are required followinga high-risk exposure to an HBsAg-positive source.

[BHIVA, 2015]

• Do not give hepatitisB vaccine to people with:
  • Current severe febrile illness.
  • A confirmed anaphylactic reaction to a previous dose of hepatitisB vaccine.
  • A confirmed anaphylactic reaction to a component of hepatitisB vaccine.

[ABPI, 2017; ABPI, 2019a; ABPI, 2018a; Joint Formulary Committee, 2019]

• HepatitisB vaccines canbe used during pregnancy and breastfeeding, if clinically indicated, for women at high-risk of infection, as hepatitis B in a pregnant woman may result in severe disease for the mother and chronic infection of the infant after birth[PHE, 2017].
  • The available evidence does not indicate any risk associated with vaccinating pregnant women, or those who are breastfeeding, with inactivated viral vaccines in general[Plotkin et al, 2004]or with hepatitis B vaccines specifically [UKTIS, 2016].

• Obtain written or verbal consent at the time of vaccination.
• Check that the vaccine is correct and has not expired. Only cleanthe site of application with soap and water if it is visibly dirty.
• For adults and children older than 1year of age, administer the vaccine by intramuscular injection into the deltoid muscle.
• For children younger than 1year of age, administer the vaccine by intramuscular injection into the anterolateral aspect of the thigh.
• If the person has a bleeding disorder, use the deep subcutaneous route, to reduce the risk of bleeding.
• Record the site of administration. If an additional vaccine is required on the same day, use separate limbs if possible, or inject at sites at least 2.5cm apart in the same limb.

[PHE, 2013]

• HepatitisB vaccine is generally well tolerated. The most common adverse reactions are soreness and redness at the injection site.
• Other reactions that have been reported (but may not be causally related) include fever, rash, malaise, an influenza-like syndrome, arthritis, arthralgia, myalgia, and abnormal liver function tests.
• Suspected serious neurological reactions (such as Guillain–Barré syndrome and demyelinating disease) have been reported, although these are very rare and a causal relationship with hepatitisB vaccine has not been established.
• The excipients in Infanrix hexavalent vaccine have been reported to cause allergic reactions and also contain phenylalanine which may be harmful in patients with phenylketonuria.

[ABPI, 2017; ABPI, 2019a; ABPI, 2018a; Joint Formulary Committee, 2019]