Hepatitis B
Information about hepatitis B disease, vaccines and recommendations for vaccination from the Australian Immunisation Handbook.
Recently added
This page was added on 06 June 2018.
Updates made
This page was updated on 01 September 2023. View history of updates
Vaccination for certain groups of people is funded under the National Immunisation Program and by states and territories.
Overview
What
Hepatitis B is an infection caused by hepatitis B virus that affects the liver. Hepatitis B virus may be transmitted by inoculation through broken or penetrated skin, or by mucosal contact with blood or other body fluids (mainly vaginal fluids and semen) from an infectious person.
Who
Hepatitis B vaccination is recommended for:
- infants
- Aboriginal and Torres Strait Islander people
- people who are immunocompromised, including people
- with HIV
- with severely impaired renal function
- on dialysis
- before solid organ transplant
- after haematopoietic stem cell transplant
- people with medical risk factors, including
- people with hepatitis C
- people with chronic liver disease
- preterm and low-birthweight infants
- people who receive blood products
- people with developmental disabilities
- people whose occupation increases their risk of acquiring hepatitis B, including
- healthcare workers
- police, members of the armed forces, emergency services staff and staff of correctional facilities
- staff of facilities caring for people with developmental disabilities
- funeral worker and embalmers
- tattooists and body-piercers
- travellers to hepatitis B–endemic areas who may be at increased risk
- people whose circumstances increase their risk of acquiring hepatitis B, including
- infants born to mothers who are hepatitis B surface antigen–positive
- household or other close contacts of people with hepatitis B
- sexual contacts of people with hepatitis B
- men who have sex with men
- migrants from hepatitis B–endemic countries
- people who inject drugs
- inmates of correctional facilities
- sex industry workers
How
Hepatitis B vaccination is recommended for infants and children in a 4-dose schedule at birth, and 2, 4 and 6 months of age.
Hepatitis B vaccination is recommended for all other risk groups, usually in a 3-dose schedule (0, 1 and 6 months). Adolescents aged 11–15 years can receive an alternative 2-dose schedule at 0 and 6 months.
Why
After acute infection with hepatitis B virus, some people become chronically infected. For those whose infection resolves, the vrius remains in latent form in liver cells and can reactivate. People with chronic hepatitis B can transmit the disease, including from mother to child. Chronic hepatitis B is associated with death from cirrhosis or hepatocellular carcinoma in up to 25% of cases.
Recommendations
Infants, children and adolescents
Infants are recommended to receive 4 doses of hepatitis B vaccine:
- 1 dose of monovalent paediatric formulation hepatitis B vaccine at birth
- 3 doses of a paediatric hepatitis B–containing vaccine at 2, 4 and 6 months of age (usually provided as DTPa-hepB-IPV-Hib [diphtheria-tetanus-acellular pertussis, hepatitis B, inactivated poliovirus, Haemophilus influenzae type b]). There is no preferential recommendation between the use of DT5aP-hepB-IPV-Hib(PRP-OMP) vaccine (Vaxelis) and DT3aP-hepB-IPV-Hib(PRP-TT) vaccine (Infanrix hexa).
Infants can receive the dose scheduled at 2 months of age as early as 6 weeks of age. They should still receive their next scheduled doses at 4 months and 6 months of age.
Hepatitis B vaccine is funded through the NIP for all infants. For details see the National Immunisation Program schedule.
Rationale for the birth dose
Rationale for the birth dose
The rationale for the birth dose for all newborn infants is to prevent:1
- vertical transmission from a mother with chronic hepatitis B, recognising that there may be errors or delays in maternal testing, reporting, communication or appropriate response
- horizontal transmission to the infant in the first months of life from people with chronic hepatitis B who are household or other close contacts
Newborns should receive the birth dose as soon as they are medically stable, and preferably within 24 hours of birth, but the vaccine can be given within the first 7 days of life. Ideally the vaccine is given before the baby is discharged from the obstetric hospital or delivery unit.
Alternative infant schedules
Alternative infant schedules
Although it is not routinely recommended in Australia, infants or toddlers who have received a 3-dose schedule of hepatitis B vaccine (often given overseas), with doses at birth, 1–2 months of age and ≥6 months of age, can also be considered fully vaccinated.
The final dose of the hepatitis B vaccine course in infants should preferably be administered at ≥24 weeks of age. However, if the final dose is given at <24 weeks but ≥16 weeks of age, it is not necessary to repeat the dose, provided the minimum intervals between doses have been met.
Infants, children and adolescents who have not received hepatitis B–containing vaccines at the recommended schedule points may need extra doses of vaccine and/or an alternative schedule.
Infants and children <10 years of age
Infants and children <10 years of age
Catch-up of the birth dose is not necessary
If an infant has not received a birth dose before they are 7 days of age, they should receive a 3-dose course of a hepatitis B–containing vaccine.
Adolescents
Adolescents
Adolescents should receive a 3-dose course of a hepatitis B–containing vaccine.
Adolescents aged 11–15 years can receive an alternative 2-dose schedule of hepatitis B vaccine using the adult formulation of either of the available monovalent vaccines.
See Catch-up vaccination for more details, including minimum intervals between doses.
Hepatitis B vaccine is funded through the NIP for all infants, children and adolescents aged <20 years who have missed a dose of hepatitis B vaccine. For details see the National Immunisation Program schedule.
Aboriginal and Torres Strait Islander people
Aboriginal and Torres Strait Islander people are recommended to:
- have their risks and vaccination status for hepatitis B reviewed
- receive testing for previous hepatitis B virus infection (see Serological testing before hepatitis B vaccination)
- receive vaccination if non-immune
Aboriginal and Torres Strait Islander people have a higher risk of acquiring new hepatitis B virus infection than non-Indigenous Australians.2,3
Adult-formulation hepatitis B vaccine should be given in a 3-dose schedule. See Table. Monovalent hepatitis B vaccines for adolescents and adults in Vaccines, dosage and administration.
See also Vaccination for Aboriginal and Torres Strait Islander people.
View recommendation detailsPeople who are immunocompromised
Children with HIV are recommended to receive 3 doses of hepatitis B vaccine using an adult formulation. This is double the recommended dose for children. In a limited number of studies, children who were immunocompromised responded better when given higher doses in a 3-dose schedule.4,5
Levels of antibody to hepatitis B surface antigen should be checked after the vaccination course. See Serological testing after hepatitis B vaccination.
See also Vaccination for people who are immunocompromised.
View recommendation detailsAdults with HIV are recommended to receive larger-than-usual doses of hepatitis B vaccine. They should receive 2 injections (1 in each arm) of the standard adult dose (using Engerix-B) on each occasion at 0, 1, 2 and 6 months. Limited studies in adults with HIV have revealed an improved and accelerated serological response to a schedule that consists of 4 double doses.6,7
Levels of antibody to hepatitis B surface antigen should be checked after the vaccination course. See Serological testing after hepatitis B vaccination.
See also Vaccination for people who are immunocompromised.
View recommendation detailsAdult haemodialysis or pre-dialysis patients are recommended to receive larger-than-usual doses of hepatitis B vaccine — either:
- 1.0 mL of Engerix-B adult formulation (20 µg) in each arm at each schedule point (that is, a double dose on each occasion) in a 4-dose schedule at 0, 1, 2 and 6 months,8 or
- a single dose of H-B-Vax II dialysis formulation (40 µg) on each occasion in a 3-dose schedule at 0, 1 and 6 months
Dialysis patients and patients with severely impaired renal function who expect to have dialysis may be at increased risk of acquiring hepatitis B virus infection. They may also respond less well to vaccination than other people.
Levels of antibody to hepatitis B surface antigen should be checked after the vaccination course. See Serological testing after hepatitis B vaccination.
See also Vaccination for people who are immunocompromised.
View recommendation detailsIf a person receiving a solid organ transplant is seronegative for hepatitis B, they are recommended to receive hepatitis B vaccine before transplantation. This is because they may be at increased risk of infection from the transplanted organ.9
An accelerated vaccination schedule can be used. See Table. Accelerated hepatitis B vaccination schedules for people with imminent risk of exposure in Vaccines, dosage and administration.
The combination hepatitis A-hepatitis B vaccine may be appropriate for people who are about to receive a liver transplant if they are not immune to either disease. This is because they have an increased risk of hepatitis B and/or severe liver disease after hepatitis A and B. See Table. Combination hepatitis A-hepatitis B vaccines.
For more details, see Hepatitis A and Vaccination for people who are immunocompromised.
View recommendation detailsPeople who have received a haematopoietic stem cell transplant are recommended to be revaccinated after transplantation. This is because of the loss of immune memory that often follows the transplant procedure.
A 3-dose schedule at 6, 8 and 12 months after transplant is required using:
- a single dose of H-B-Vax II dialysis formulation (40 µg) at each schedule point, or
- Engerix-B adult formulation (20 µg) in each arm at each schedule point (that is, a double dose on each occasion), or
- the standard vaccination course, with checking of serology 4–8 weeks after the last vaccine dose
See also Vaccination for people who are immunocompromised.
View recommendation detailsBooster doses of hepatitis B vaccine are recommended for people who are immunocompromised, particularly people with HIV or renal failure.
Monitor the person’s levels of antibody to hepatitis B surface antigen every 6–12 months and give a booster dose when needed. See Serological testing after hepatitis B vaccination.10
View recommendation detailsPeople with other medical conditions
Hepatitis B vaccination is recommended for people with chronic liver disease and/or hepatitis C who are seronegative for hepatitis B. This is because they may have an increased risk of hepatitis B and/or severe liver disease after hepatitis B.11
Adult-formulation hepatitis B vaccine should be given in a 3-dose schedule. See Table. Monovalent hepatitis B vaccines for adolescents and adults in Vaccines, dosage and administration.
Levels of antibody to hepatitis B surface antigen should be checked after the vaccination course. See Serological testing after hepatitis B vaccination.
The combination hepatitis A-hepatitis B vaccine may be appropriate for people with chronic liver disease and/or hepatitis C if they are not immune to either disease. This is because they have an increased risk of hepatitis B and/or severe liver disease after hepatitis A and B. See Table. Combination hepatitis A-hepatitis B vaccines in Vaccines, dosage and administration.
For more details, see Hepatitis A and Vaccination for special risk groups.
View recommendation detailsLow-birthweight and preterm newborns do not respond as well to hepatitis B–containing vaccines as full-term infants.12-14
Low-birthweight infants (<2000 g) and/or infants born at <32 weeks gestation (regardless of weight) are recommended to receive a 4-dose schedule at 0 (birth), 2, 4 and 6 months of age, followed by either:
- giving a booster of a hepatitis B–containing vaccine at 12 months of age (without measuring the antibody titre), or
- measuring the level of antibody to hepatitis B surface antigen at 7 months of age; if the antibody titre is <10 mIU per mL, they should receive a booster at 12 months of age (because of a better immunogenic response at this age compared with a younger age)
The following groups are recommended to receive hepatitis B vaccine because of their increased risk of infection through blood products:15
- people with clotting disorders who receive blood product concentrates
- people with recurrent transfusion requirements
- people with underlying immunocompromising conditions who receive blood products
All blood donors in Australia are screened for hepatitis B using tests for hepatitis B surface antigen and nucleic acid amplification. This has greatly decreased the incidence of transfusion-related hepatitis B virus infection.
Adult-formulation hepatitis B vaccine should be given in a 3-dose schedule. See Table. Monovalent hepatitis B vaccines for adolescents and adults in Vaccines, dosage and administration.
View recommendation detailsPeople with developmental disabilities who attend either residential or non-residential daycare facilities are recommended to receive hepatitis B vaccine. This is because of the high prevalence of markers indicating past or current infection in people in these settings, including a prevalence of hepatitis B surface antigen of >10%.16-18
Adult-formulation hepatitis B vaccine should be given in a 3-dose schedule. See Table. Monovalent hepatitis B vaccines for adolescents and adults in Vaccines, dosage and administration.
The combination hepatitis A-hepatitis B vaccine may be appropriate for people with developmental disabilities if they are not immune to either disease. This is because they have an increased risk of both conditions. See Table. Combination hepatitis A-hepatitis B vaccines in Vaccines, dosage and administration.
For more details, see Hepatitis A and Vaccination for special risk groups.
View recommendation detailsPeople at occupational risk
Hepatitis B vaccine is recommended for people who work in any occupation that involves any of:
- direct patient care
- handling human tissue, blood or body fluids
- handling used needles or syringes
These people should also routinely follow standard precautions against exposure to human tissue, blood or body fluids.19
The risk to people in certain occupations differs considerably between settings in different parts of Australia. Workers who have an increased risk of acquiring hepatitis B include:
- healthcare workers
- police, members of the armed forces, emergency services staff and staff of correctional facilities, if they are assigned to duties that may involve exposure to human tissue, blood or body fluids
- funeral workers, embalmers and other workers who have regular contact with human tissue, blood or body fluids, or used needles or syringes
- staff involved in both residential and non-residential care of people with developmental disabilities, because of the high prevalence of markers of past or current infection in people in this setting16-18
- workers who perform skin penetration procedures, such as tattooists and body-piercers
Early childhood educators and carers are normally at minimal risk of hepatitis B transmission. The local public health authority can provide advice about risk if needed.
Adult-formulation hepatitis B vaccine should be given in a 3-dose schedule. See Table. Monovalent hepatitis B vaccines for adolescents and adults in Vaccines, dosage and administration.
Levels of antibody to hepatitis B surface antigen should be checked after the vaccination course. See Serological testing after hepatitis B vaccination. The combination hepatitis A-hepatitis B vaccine may be appropriate for people with an occupational risk of exposure to both hepatitis A and B if they are not immune to either disease. See Table. Combination hepatitis A-hepatitis B vaccines in Vaccines, dosage and administration.
For more details, see Hepatitis A and Vaccination for people at occupational risk.
View recommendation detailsTravellers
Travellers are recommended to receive hepatitis B vaccine if they are visiting regions of intermediate or high endemicity, and either:
- travelling for a long time, or taking short, frequent trips, or
- likely to participate in activities that increase their risk of exposure to hepatitis B virus20
Adult-formulation hepatitis B vaccine should be given in a 3-dose schedule. See Table. Monovalent hepatitis B vaccines for adolescents and adults in Vaccines, dosage and administration.
An accelerated vaccination schedule can be used in exceptional circumstances for people intending to travel to hepatitis B–endemic areas with a very limited time before departure. See Table. Accelerated hepatitis B vaccination schedules for people with imminent risk of exposure in Vaccines, dosage and administration.
The combination hepatitis A-hepatitis B vaccine may be appropriate for travellers if they are not immune to either disease and are travelling to an area of high hepatitis A endemicity. See Table. Combination hepatitis A-hepatitis B vaccines in Vaccines, dosage and administration.
For more details, see Hepatitis A and Vaccination for international travellers.
View recommendation detailsOther groups
All newborns of mothers known to have chronic hepatitis B must receive both:
- a birth dose of monovalent hepatitis B vaccine and
- hepatitis B immunoglobulin (HBIG)
These should both be given on the day of birth, at the same time but in separate thighs.
The dose of HBIG is 100 IU given by intramuscular injection. Infants should receive HBIG immediately after birth — preferably within 12 hours of birth and certainly within 48 hours. Its efficacy decreases markedly if given more than 48 hours after birth.
Give the dose of monovalent hepatitis B vaccine preferably within 24 hours of birth, and definitely within 7 days. This regimen results in seroconversion rates of more than 90% in neonates, even with concurrent administration of HBIG.
Do not delay vaccination beyond 7 days after birth, because vaccination alone is reasonably effective in preventing infection if it is given early enough.21 Infants should receive 3 subsequent doses of a hepatitis B–containing vaccine at 2, 4 and 6 months of age, so that they receive a total of 4 doses of hepatitis B–containing vaccines.
Measuring antibody and HBsAg levels after vaccine and immunoglobulin administration
Measuring antibody and HBsAg levels after vaccine and immunoglobulin administration
Measure levels of hepatitis B surface antigen (HBsAg) and anti-HBs (antibody to HBsAg) in infants born to mothers with chronic hepatitis B 3–12 months after completing the infant vaccine course.
Do not test the infant before 9 months of age, to avoid detecting anti-HBs from the HBIG given at birth.
The infant is protected against hepatitis B if:22
- anti-HBs levels are adequate (≥10 mIU per mL) and
- HBsAg is negative
See Serological testing following hepatitis B vaccination.
If the anti-HBs level is <10 mIU per mL, seek expert advice about revaccination or further testing.
Maternal screening
Maternal screening
Routine antenatal screening of pregnant women for HBsAg enables appropriate management to prevent newborn infants developing hepatitis B. See Clinical features and Epidemiology.23-25
Screening also enables appropriate:
Susceptible household-like contacts of people with hepatitis B are recommended to receive hepatitis B vaccine. This includes household members of an adoptive family if the adopted child is known to have chronic hepatitis B.
There is a low, but definite, risk of transmission from a person with acute or chronic hepatitis B to household or other close (household-like) contacts. Examples of household-like contacts are students or asylum seekers sharing residential facilities. This risk can be reduced by avoiding contact with blood and other body fluids, and not sharing items that may penetrate the skin (such as combs, nail brushes, toothbrushes and razors).
Adult-formulation hepatitis B vaccine should be given in a 3-dose schedule. See Table. Monovalent hepatitis B vaccines for adolescents and adults in Vaccines, dosage and administration.
Levels of antibody to hepatitis B surface antigen should be checked after the vaccination course. See Serological testing after hepatitis B vaccination.
View recommendation detailsSusceptible sexual partners of people who are positive for hepatitis B surface antigen are recommended to receive post-exposure hepatitis B immunoglobulin (HBIG) and hepatitis B vaccination.
Both the vaccine course and HBIG should start within 14 days of the last sexual contact. See Public health management and Table. Post-exposure prophylaxis for non-immune people exposed to a source that is positive for hepatitis B surface antigen.
Susceptible clients of sexual health services are recommended to receive hepatitis B vaccine when they first attend the service. This is because hepatitis B is relatively common in clients of sexual health services.
Adult-formulation hepatitis B vaccine should be given in a 3-dose schedule. See Table. Monovalent hepatitis B vaccines for adolescents and adults in Vaccines, dosage and administration.
Levels of antibody to hepatitis B surface antigen should be checked after the vaccination course. See Serological testing after hepatitis B vaccination.
View recommendation detailsSusceptible sexually active men who have sex with men are recommended to receive hepatitis B vaccine.
Adult-formulation hepatitis B vaccine should be given in a 3-dose schedule. See Table. Monovalent hepatitis B vaccines for adolescents and adults in Vaccines, dosage and administration.
Levels of antibody to hepatitis B surface antigen should be checked after the vaccination course. See Serological testing after hepatitis B vaccination.
The combination hepatitis A-hepatitis B vaccine may be appropriate for men who have sex with men if they are not immune to either disease. This is because they have an increased risk of both conditions. See Table. Combination hepatitis A-hepatitis B vaccines in Vaccines, dosage and administration.
For more details, see Hepatitis A and Vaccination for other groups.
View recommendation detailsMigrants from hepatitis B–endemic countries are recommended to receive testing for hepatitis B, and vaccination if appropriate.
These people are more likely to:
- have been previously infected with hepatitis B virus
- have a close household contact with chronic hepatitis B
Areas of high endemicity, indicated by high seroprevalence of hepatitis B surface antigen, include:20
- most of East and Southeast Asia (except Japan)
- Pacific island countries
- parts of central Asia and the Middle East
- the Amazon Basin
- sub-Saharan Africa
Adult-formulation hepatitis B vaccine should be given in a 3-dose schedule. See Table. Monovalent hepatitis B vaccines for adolescents and adults in Vaccines, dosage and administration.
See also Vaccination for migrants, refugees and people seeking asylum in Australia.
View recommendation detailsPeople who inject drugs are recommended to receive testing for hepatitis B, and vaccination if appropriate.
Adult-formulation hepatitis B vaccine should be given in a 3-dose schedule. See Table. Monovalent hepatitis B vaccines for adolescents and adults in Vaccines, dosage and administration.
The combination hepatitis A-hepatitis B vaccine may be appropriate for people who inject drugs if they are not immune to either disease. This is because they have an increased risk of both conditions. See Table. Combination hepatitis A-hepatitis B vaccines in Vaccines, dosage and administration.
For more details, see Hepatitis A and Vaccination for other groups.
View recommendation detailsInmates of correctional facilities are recommended to receive testing for hepatitis B, and vaccination if appropriate.
This should be part of the facility’s preventive health program for bloodborne viruses.
Inmates have an increased risk of hepatitis B virus infection because of:
- the prevalence of chronic hepatitis B among inmates
- the potential for unprotected sex
- injecting drug use
- amateur tattooing
Adult-formulation hepatitis B vaccine should be given in a 3-dose schedule. See Table. Monovalent hepatitis B vaccines for adolescents and adults in Vaccines, dosage and administration.
The combination hepatitis A-hepatitis B vaccine may be appropriate for inmates of correctional facilities if they are not immune to either disease. This is because they have an increased risk of both conditions. See Table. Combination hepatitis A-hepatitis B vaccines in Vaccines, dosage and administration.
For more details, see Hepatitis A and Vaccination for other groups.
View recommendation detailsSex industry workers are recommended to receive hepatitis B vaccine if they are not immune.
Sex industry workers are at higher risk of hepatitis B virus infection. This industry is an important focus for preventing hepatitis B transmission.26 Sex industry workers are at a particularly high risk if they engage in unprotected sex.
Adult-formulation hepatitis B vaccine should be given in a 3-dose schedule. See Table. Monovalent hepatitis B vaccines for adolescents and adults in Vaccines, dosage and administration.
Levels of antibody to hepatitis B surface antigen should be checked after the vaccination course. See Serological testing after hepatitis B vaccination.
The combination hepatitis A-hepatitis B vaccine may be appropriate for sex workers if they are not immune to either disease. This is because they have an increased risk of both conditions. See Table. Combination hepatitis A-hepatitis B vaccines in Vaccines, dosage and administration.
For more details, see Hepatitis A and Vaccination for other groups.
View recommendation detailsSerological testing before hepatitis B vaccination
Routine antenatal screening of all pregnant women for hepatitis B surface antigen (HBsAg) is recommended. This allows appropriate measures (such as referral to an appropriate infectious disease specialist) to be taken to prevent newborn infants developing chronic hepatitis B.23-25 See Infants born to mothers who are hepatitis B surface antigen–positive are recommended to receive both hepatitis B vaccine and HBIG. See Laboratory diagnosis.
View recommendation detailsSerological testing for hepatitis B virus infection before vaccination may be warranted for some older children, adolescents and adults. This is particularly so for those at increased risk of acquiring hepatitis B virus infection, such as:
- people who inject drugs
- sex industry workers
- people who are immunocompromised
- people living in communities with higher prevalence of hepatitis B, including migrant communities, and Aboriginal and Torres Strait Islander people
Serological testing of people at higher risk:
- allows people with hepatitis B to receive appropriate clinical management
- prevents onward transmission, which reduces the population impact of hepatitis B
- identifies people who are susceptible to hepatitis B virus infection so that they can be offered vaccination
See Recommendations.26
People at increased risk of hepatitis A virus exposure (see Hepatitis A) can also have serological testing for hepatitis A. If they are susceptible, they are recommended to receive a combination hepatitis A-hepatitis B vaccine.
When interpreting serological testing results, it may be useful to discuss the results with the laboratory that performed the test, to ensure that decisions are based on all relevant clinical information. See Laboratory diagnosis.
View recommendation detailsSerological testing after hepatitis B vaccination
It is recommended that levels of hepatitis B surface antigen (HBsAg) and antibody to HBsAg (anti-HBs) in infants born to mothers with chronic hepatitis B are measured 3–12 months after they complete the infant vaccine course. Do not test the infant before 9 months of age, to avoid detecting anti-HBs from the hepatitis B immunoglobulin given at birth. See Infants born to mothers who are hepatitis B surface antigen–positive are recommended to receive both hepatitis B vaccine and HBIG. See Laboratory diagnosis.
View recommendation detailsPost-vaccination serological testing is recommended 4–8 weeks after completing the vaccine course for:
- people at significant occupational risk, such as healthcare workers whose work involves frequent exposure to human tissue, blood or body fluids
- people at risk of severe or complicated hepatitis B, such as people who are immunocompromised and people with pre-existing liver disease not related to hepatitis B
- people who may respond poorly to hepatitis B vaccination, such as haemodialysis patients and people with bleeding disorders who received the vaccine subcutaneously
- close contacts of people who are infected with hepatitis B virus, including sexual partners, household contacts and household-like contacts22
If serological testing 4–8 weeks after the vaccine course shows levels of antibody to hepatitis B surface antigen (anti-HBs) of <10 mIU per mL, check the person for acute or chronic hepatitis B virus infection by testing for serological markers, including antibodies to anti-HBs and hepatitis B core antigen.
In select cases, when hepatitis B virus infection is suspected, confirm with nucleic acid testing for hepatitis B virus. Seek expert advice about further management.
If there are no markers of hepatitis B virus infection, manage the person as a non-responder to hepatitis B vaccination. See Non-responders to hepatitis B vaccine are recommended to receive further doses and serological testing.
People who are at significant risk of hepatitis B (such as healthcare workers) are recommended to be tested for immunity if they were not tested for anti-HBs 4–8 weeks after finishing a course of hepatitis B vaccine.
See Laboratory diagnosis.
Booster doses
Booster doses
If people who receive serological testing after a course of hepatitis B vaccine have an anti-HBs level of <10 mIU per mL, they are recommended to receive a single booster dose (4th dose) of vaccine.
People with immune memory established from effective previous vaccination should respond to this booster dose.
After the booster dose, check for anti-HBs again 4 weeks later:
- If the anti-HBs levels remain <10 mIU per mL, investigate the possibility of hepatitis B virus infection.
- If the person does not have hepatitis B virus infection, manage them as a non-responder to vaccination (see Non-responders to hepatitis B vaccine are recommended to receive further doses and serological testing).
- If the anti-HBs level is ≥10 mIU per mL, the person is considered immune.
See Laboratory diagnosis.
A non-responder is a person who:
- is not infected with hepatitis B virus
- has a documented history of an age-appropriate course of hepatitis B vaccine
- has a current level of antibody to hepatitis B surface antigen (anti-HBs) of <10 mIU per mL (4-8 weeks after a booster dose)
People who do not respond to this vaccination course, and in whom chronic hepatitis B virus infection has been excluded, should be offered further doses.
People can receive a single booster dose (4th dose) of vaccine to confirm non-responder status. See Serological testing after hepatitis B vaccination.
People who are non-responders after receiving the booster should be tested for hepatitis B virus infection. If negative, they are recommended to receive 2 more doses of hepatitis B vaccine 1 month apart. Count the 4th booster dose as the 1st of the 3 repeat doses. Re-test the person for anti-HBs levels at least 4 weeks after the last dose. See Laboratory diagnosis.
A few small studies have reported that non-responders can achieve seroprotection after receiving high-dose formulations or double-dose administration as the 4th, or subsequent, dose of hepatitis B vaccine. However, no consistent evidence suggests that a higher proportion of people would respond with these higher-dose regimens.27-29
Intradermal vaccination in non-responders
Intradermal vaccination in non-responders
Some small observational studies report that some non-responders may respond to intradermal vaccination against hepatitis B.30-32 These results apply to hepatitis B surface antigen–negative healthcare workers who are non-responders to a 3-dose course of vaccination and to subsequent additional intramuscular doses (≥5 doses in total).
These studies used up to 4 doses of Engerix-B (0.25 mL [5 μg] per dose).30 Younger age and longer duration (≥6 months) since the last intramuscular dose may be associated with a better chance of responding.31
If a person receives an intradermal dose(s), it is recommended that the anti-HBs levels are measured before each subsequent dose to check for seroconversion. See Laboratory diagnosis.
Persistent non-responders
Persistent non-responders
Inform persistent non-responders that they are probably not protected against hepatitis B, and should minimise potential exposure.
Also inform them about the need for hepatitis B immunoglobulin within 72 hours of parenteral or mucosal exposure to hepatitis B virus (see Table. Post-exposure prophylaxis for non-immune people exposed to a source that is positive for hepatitis B surface antigen in Public health management).
Vaccines, dosage and administration
Hepatitis B vaccines available in Australia
The Therapeutic Goods Administration website provides product information for each vaccine.
See also Vaccine information and Variations from product information for more details.
Monovalent vaccines
Registered for use from birth.
Recombinant hepatitis B vaccine
Adult formulation
Each 1.0 mL monodose vial or pre-filled syringe contains:
- 20 µg recombinant hepatitis B surface antigen (HBsAg) protein, adsorbed onto 0.5 mg aluminium as aluminium hydroxide hydrate
Paediatric formulation
Each 0.5 mL monodose vial or pre-filled syringe contains:
- 10 µg HBsAg protein, adsorbed onto 0.25 mg aluminium as aluminium hydroxide hydrate
Both formulations may contain yeast proteins.
For Product Information and Consumer Medicine Information about Engerix-B visit the Therapeutic Goods Administration website.
View vaccine detailsRegistered for use from birth.
Recombinant hepatitis B vaccine
Adult formulation
Each 1.0 mL monodose vial or pre-filled syringe contains:
- 10 µg recombinant hepatitis B surface antigen (HBsAg) protein, adsorbed onto 0.5 mg amorphous aluminium hydroxyphosphate sulfate
Paediatric formulation
Each 0.5 mL monodose vial or pre-filled syringe contains:
- 5 µg recombinant HBsAg protein, adsorbed onto 0.25 mg amorphous aluminium hydroxyphosphate sulfate
Dialysis formulation
Each 1.0 mL monodose vial contains:
- 40 µg recombinant HBsAg protein, adsorbed onto 0.5 mg amorphous aluminium hydroxyphosphate sulfate
All formulations contain latex and may contain yeast proteins.
For Product Information and Consumer Medicine Information about H-B-Vax II visit the Therapeutic Goods Administration website.
View vaccine detailsCombination vaccines
Registered for use in infants and children aged ≥6 weeks.
DTPa-HepB-IPV-Hib — diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated poliovirus-Haemophilus influenzae type b conjugate vaccine
The vaccine is a combination vaccine and consists of both a 0.5 mL monodose pre-filled syringe and a vial containing a lyophilised pellet.
The vaccine needs to be reconstituted by adding the entire contents of the pre-filled syringe containing the liquid component to the vial containing the lyophilised pellet.
Each 0.5 mL reconstituted dose contains:
- ≥30 IU Diphtheria toxoid1
- ≥40 IU Tetanus toxoid1
- 25 µg Pertussis toxoid (PT)1
- 25 µg Filamentous Haemagglutinin (FHA)1
- 8 µg Pertactin (PRN)1
- 10 µg Hepatitis B surface antigen (HBsAg)2,3
- 40 D-antigen units Inactivated Poliovirus Type 1 (Mahoney)4
- 8 D-antigen units Inactivated Poliovirus Type 2 (MEF-1)4
- 32 D-antigen units Inactivated Poliovirus Type 3 (Saukett)4
- 10 µg Haemophilus influenzae type b polysaccharide (Polyribosylribitol Phosphate)3
- 20-40 µg Haemophilus influenzae type b polysaccharide (conjugated to tetanus toxoid protein)
1 adsorbed onto aluminium hydroxide/phosphate
2 produced in yeast (Saccharomyces cerevisiae) cells by recombinant DNA technology
3 adsorbed on aluminium phosphate
4 propagated in VERO cells
Also contains traces of:
- polymyxin B sulfate
- neomycin sulfate
- Lactose
For Product Information and Consumer Medicine Information about Infanrix Hexa visit the Therapeutic Goods Administration website.
View vaccine detailsRegistered for use in people aged ≥1 year.
Hepatitis A and hepatitis B combination vaccine
Each 1.0 mL monodose vial or pre-filled syringe contains:
- 720 ELISA units of inactivated hepatitis A virus (HM175 strain)
- 20 µg recombinant hepatitis B surface antigen protein
- 0.45 mg aluminium as aluminium phosphate and aluminium hydroxide
Also contains traces of:
- formaldehyde
- neomycin
- trometamol
- polysorbate 20
May contain yeast proteins.
For Product Information and Consumer Medicine Information about Twinrix (720/20) visit the Therapeutic Goods Administration website.
View vaccine detailsRegistered for use in children aged 1–15 years.
Hepatitis A and hepatitis B vaccine combination vaccine.
Each 0.5 mL monodose vial or pre-filled syringe contains:
- 360 ELISA units of inactivated hepatitis A virus (HM175 strain)
- 10 µg recombinant hepatitis B surface antigen protein
- 0.225 mg aluminium as aluminium phosphate and aluminium hydroxide
Also contains traces of:
- formaldehyde
- neomycin
- trometamol
- polysorbate 20
May contain yeast proteins.
For Product Information and Consumer Medicine Information about Twinrix (360/10) visit the Therapeutic Goods Administration website.
View vaccine detailsRegistered for use in infants and toddlers aged ≥6 weeks.
DT5aP-hepB-IPV-Hib(PRP-OMP) - (Diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliovirus(inactivated), and Haemophilus influenzae type b conjugate vaccine.
The vaccine is a combination vaccine and consists of a monodose of 0.5 mL suspension in a pre-filled syringe.
The 0.5mL monodose suspension contains:
- ≥20 IU Diphtheria toxoid
- ≥40 IU Tetanus toxoid
- 20 µg Pertussis toxoid (PT)
- 20 µg Filamentous Haemagglutinin (FHA)
- 3 µg Pertactin (PRN)
- 5 µg Fimbriae types 2 and 3 (FIM)
- 10 µg Hepatitis B surface antigen (HBsAg)
- 40 D-antigen units Inactivated Poliovirus Type 1 (Mahoney)
- 8 D-antigen units Inactivated Poliovirus Type 2 (MEF-1)
- 32 D-antigen units Inactivated Poliovirus Type 3 (Saukett)
- 3 µg Haemophilus influenzae type b polysaccharide (Polyribosylribitol Phosphate)
- 50 µg Haemophilus influenzae type b polysaccharide (conjugated to meningococcal protein)
Also contains traces of:
- glutaraldehyde
- formaldehyde
- polymyxin B
- neomycin
- streptomycin
- bovine serum albumin
- dibasic and monobasic sodium phosphate
May contain yeast proteins.
For Product Information and Consumer Medicine Information about Vaxelis visit the Therapeutic Goods Administration website.
Vaxelis can be given at the same time as other scheduled vaccines, including MenB vaccines.
View vaccine detailsDose and route
The dose of Engerix-B and H-B-Vax II (paediatric formulations) and Twinrix Junior (360/10) is 0.5 mL given by intramuscular injection.
The dose of Engerix-B and H-B-Vax II (adult formulations) and Twinrix (720/20) is 1.0 mL given by intramuscular injection.
The dose of Infanrix hexa and Vaxelis is 0.5 mL given by intramuscular injection.
The schedules for hepatitis B vaccines are shown in:
Vaccine | Age of vaccine recipient (years) | Dose (hepatitis B surface antigen protein) | Number of doses | Recommended schedule minimum intervals | Alternative schedule minimum intervals |
---|---|---|---|---|---|
Engerix-B (adult formulation) | 11–15 only | 20 μg | 2 |
|
Not applicable |
Engerix-B (paediatric formulation) | <20 | 10 μg | 3 |
|
OR
|
Engerix-B (adult formulation) | ≥20 | 20 μg | 3 |
|
OR
|
H-B-Vax II (adult formulation) | 11–15 only | 10 μg | 2 |
|
Not applicable |
H-B-Vax II (paediatric formulation) | <20 | 5 μg | 3 |
|
OR
|
H-B-Vax II (adult formulation) | ≥20 | 10 μg | 3 |
|
OR
|
H-B-Vax II (dialysis formulation) | ≥20 | 40 μg | 3 |
|
Not applicable |
Vaccine | Age of vaccine recipient (years) | Dose (hepatitis B surface antigen protein) | Number of doses | Recommended schedule minimum interval |
---|---|---|---|---|
Engerix-B (paediatric formulation) | <20 | 10 μg | 4 |
|
Engerix-B (adult formulation) | ≥20 | 20 μg | 4 |
or
|
Twinrix (720/20) | ≥16 | 20 μg | 4 |
|
Vaccine | Age of vaccine recipient (years) | Dose (hepatitis B surface antigen protein) | Number of doses | Recommended schedule minimum intervals |
---|---|---|---|---|
Twinrix (720/20) | 1 to <16 | 20 μg | 2 |
Do not use this schedule for people who need rapid protection against hepatitis B (such as people who have had close contact with a person with hepatitis B) |
Twinrix Junior (360/10) | 1 to <16 | 10 μg | 3 |
|
Twinrix (720/20) | ≥16 | 20 μg | 3 |
|
Co-administration with other vaccines
People can receive hepatitis B and combination hepatitis A-hepatitis B vaccines at any time before or after, or with, most other vaccines.
Vaxelis can be given at the same time as other scheduled vaccines, including MenB vaccines.
Interchangeability of hepatitis B vaccines
The Engerix-B and H-B-Vax II vaccines are manufactured by different processes, and the hepatitis B surface antigen content of an ‘equivalent’ dose of these vaccines is different. Switching vaccine brands is not recommended.
If possible, complete the vaccination schedule for Infanrix hexa and Vaxelis with the same vaccine brand. If this is not possible, use an alternative brand following the dose recommendations. See Recommendations - Infants are recommended to receive 4 doses of hepatitis B vaccine.
If the brand of vaccine used for previous doses is not known, use another age-appropriate ‘equivalent’ dose brand. See:
- Hepatitis B vaccines available in Australia
- Table. Monovalent hepatitis B vaccines for adolescents and adults
For example, a study in healthy neonates showed comparable high levels of immunogenicity between 2 different mixed regimens that used 2 monovalent hepatitis B vaccines from different manufacturers.33
Hepatitis B immunoglobulin
160 mg/mL immunoglobulin (mainly IgG) prepared from human plasma–containing high levels of antibody to surface antigen of hepatitis B virus.
Single vials contain 100 IU or 400 IU hepatitis B antibody, with the actual volume stated on the label on the vial. Also contains glycine.
View immunoglobulin detailsHepatitis B immunoglobulin (HBIG) is prepared from plasma donated through routine blood bank collection. Samples are selected based on their high levels of antibody to hepatitis B surface antigen.
Stocks of HBIG are very limited, so HBIG should be strictly reserved for people who are at high risk, such as:
- babies born to mothers with chronic hepatitis B virus infection
- people who are non-immune and are occupationally exposed to the blood of unidentified people
- people who are chronically infected with hepatitis B virus or whose hepatitis status cannot be determined in time34
Request HBIG from the Australian Red Cross Blood Service in your state or territory.
Contraindications and precautions
Contraindications
Hepatitis B vaccines are contraindicated in people who have had:
- anaphylaxis after a previous dose of any hepatitis B vaccine
- anaphylaxis after any component of a hepatitis B vaccine
- anaphylaxis to yeast
Precautions
Women who are pregnant or breastfeeding
Hepatitis B vaccine is not routinely recommended for pregnant or breastfeeding women.
However, the World Health Organization states that pregnancy and breastfeeding are not contraindications for hepatitis B vaccination. 34
See Table. Vaccines that are not routinely recommended in pregnancy: inactivated viral vaccines in Vaccination for women who are planning pregnancy, pregnant or breastfeeding for more details.
People with latex allergy
The product information for H-B-Vax II states that the vial stopper, syringe plunger stopper and tip cap of the syringe contain latex. Consider using an alternative product in people with an allergy or sensitivity to latex.
Adverse events
Newborns
Newborns tolerate the birth dose of hepatitis B vaccine very well. The vaccine does not interfere with either establishing or maintaining breastfeeding. In newborns who were vaccinated compared with unvaccinated infants, the vaccine is not associated with an increased risk of: 35-37
- fever (occurs in 0.6–3.7% of neonates)
- medical investigation for sepsis
- serious outcomes
Adults
Adverse events after hepatitis B vaccination are transient and minor, and include:22
- soreness at the injection site (5%)
- fever (usually low grade; 2–3%)
- nausea
- dizziness
- myalgia
- arthralgia
Anaphylaxis is reported very rarely in adults, usually in yeast-sensitive individuals.38 Various adverse events such as demyelinating diseases, Guillain–Barré syndrome and arthritis have been reported, but there is no evidence that hepatitis B vaccination causes these.38,39
The World Health Organization Global Advisory Committee on Vaccine Safety states that ‘multiple studies and review panels have concluded that there is no link between multiple sclerosis and hepatitis B vaccination’.40,41
Combination vaccines
Local and systemic adverse reactions are more common after hexavalent vaccines than after monovalent vaccines. There is little to no difference in the rates of adverse events after hexavalent vaccines compared with other combination vaccines including other hexavalent vaccines.42-44
People with chronic hepatitis B
The vaccine does not affect people with chronic hepatitis B virus infection — there are no therapeutic benefits or associated adverse events. The vaccine is also safe in people who are already immune to hepatitis B through past natural infection, but it offers no additional benefit.
Nature of the disease
Hepatitis B is an infection caused by hepatitis B virus. It affects the liver.
Pathogenesis
The incubation period is usually 45–180 days. The period of communicability starts from several weeks before the onset of acute illness, and usually lasts 4–5 months while hepatitis B surface antigen (HBsAg) is present. People with chronic infection usually remain infectious for life.
Transmission
Hepatitis B virus may be transmitted by inoculation through broken or penetrated skin, or by mucosal contact with blood or other body fluids (mainly vaginal fluids and semen) from an infectious person. The 3 major routes of hepatitis B virus transmission are:
- perinatal
- parenteral
- mucosal (often sexual)
Perinatal transmission
Perinatal transmission occurs from infected the mother to the neonate usually at, or around the time of birth. This is also called vertical transmission.
Parenteral exposure to infected blood and other body fluids
Examples of parenteral transmission include:
- exposure to contaminated equipment that penetrates the skin, such as needles (among people who inject drugs), tattoo equipment, medical or dental equipment if there is poor infection control, body-piercing equipment, acupuncture equipment and razor blades
- needlestick injury, such as in a healthcare setting
- household transmission, such as child-to-child transmission through contact between open sores or wounds
In Australia, blood and organ donors are screened for hepatitis B virus using serological and nucleic acid amplification testing. This has nearly eliminated the risk of transmission of hepatitis B through blood transfusion and organ transplants.45,46
Mucosal exposure to infected blood and other body fluids
Mucosal exposure occurs when there is contact between infective body fluids and mucous membranes.
Sexual contact includes vaginal and anal intercourse. Anal sex is associated with a higher risk.
Saliva may be infective only if inoculated directly into tissue (ocular or mucous membranes).
The risk of transmission by inadvertent inoculation by other means is low but not negligible. Transmission could be by:47-54
- sharing a toothbrush, razor or similar
- close personal contact in households that have 1 or more infected people
Laboratory diagnosis
Hepatitis B virus infection is diagnosed by serological testing. Hepatitis B serology allows clinicians to determine susceptibility, active infection, or immunity through vaccination or past infection. The following markers are tested for:
- HBsAg — acute infection
- antibody to HBsAg (anti-HBs) — immunity from immunisation or infection
- antibody to hepatitis B core antigen (anti-HBc) — acute or chronic infection
Markers and results | Interpretation |
---|---|
|
Susceptible |
|
Immune from natural infection |
|
Immune from vaccination |
|
Acute infection |
|
Chronic infection |
|
Inconclusive |
Source: Adapted from recommendations of the Advisory Committee on Immunization Practices52 |
Clinical features
Acute hepatitis B
Hepatitis B virus infection causes symptomatic acute hepatitis in approximately 30–50% of adults. In neonates and young children, particularly those <1 year of age, the initial infection is usually asymptomatic.56,57
Acute hepatitis B is clinically indistinguishable from other forms of hepatitis. Symptoms of hepatitis include: 58,59
- fever
- jaundice
- malaise
- anorexia
- nausea
- vomiting
- abdominal pain (especially in the right upper quadrant)
- myalgia
- dark-coloured urine
- light-coloured stools
- arthralgia
- arthritis
- rash
During recovery, malaise and fatigue can last for many weeks.
Fulminant hepatitis occurs in up to 1% of acute cases.58,59
Chronic hepatitis B
Some people become chronically infected with hepatitis B virus after acute infection. This happens in about 1–10% of people infected in adulthood,,57,60 but up to 90% of people infected in early infancy.60 People chronically infected with hepatitis B virus have circulating hepatitis B surface antigen for >6 months.58,59
People with chronic hepatitis B virus infection can transmit the disease, including from mother to child. These people are often asymptomatic and may not be aware that they are infected.
Chronic hepatitis B virus infection is associated with most of the serious complications. Chronic hepatitis B is associated with death from cirrhosis and/or hepatocellular carcinoma in up to 25% of cases.58
People with occult infection may reactivate hepatitis B virus infection if they become immunocompromised.
Epidemiology
Hepatitis B in Australia
Hepatitis B remains the most common blood-borne viral infection in Australia. The estimated prevalence of chronic hepatitis B in 2020 was 0.9%. Populations most affected by hepatitis B within Australia are Aboriginal and Torres Strait Islander people and those born overseas.61-64
Since the introduction of funded universal infant hepatitis B immunisation, Australia has seen a three-fold decline in the rate of newly acquired hepatitis B notifications between 2000 and 2019.65 There were 4,945 notifications reported during this period (average annual rate 1.13 per 100,000 population per year). Similarly, between 2001 and 2019 annual hospitalisation rates have halved.65 Between 2000 and 2019, there were 253 deaths reported where acute hepatitis B was the underlying cause of death. There were no deaths reported among people born after May 2000.
The average annual notification rate was highest among young adults aged 25–29 years and lowest among young children <10 years of age.65 Notification rates and mortality were three-fold higher in males compared to females. Although notification rates have halved among Aboriginal and Torres Strait Islander people, both notification and hospitalisation rates remain higher than other people.65
Of the notifications where country of birth was known, 75% of newly acquired hepatitis B were in people born in Australia and the vast majority (93%) were acquired within Australia, with a small proportion (3%) acquired in South-East Asia.65 More than two-thirds of people living with chronic hepatitis B in Australia were born (and likely acquired hepatitis B) overseas.64
Hepatitis B Globally
The World Health Organization estimates that 296 million people were living with chronic hepatitis B infection in 2019, with 1.5 million new infections each year. In 2019, hepatitis B resulted in an estimated 820,000 deaths, mostly from cirrhosis and hepatocellular carcinoma (primary liver cancer).66 The burden due to chronically infected people is highest in the WHO Western Pacific Region (116 million) and the WHO African Region (81 million). This is followed by the WHO Eastern Mediterranean Region (60 million), the WHO South-East Asia Region (18 million), the WHO European Region (14 million) and the WHO Region of the Americas (5 million).66
Vaccine information
Hepatitis B vaccines are prepared using recombinant technology. After purification, the hepatitis B surface antigen (HBsAg) protein is adsorbed onto elemental aluminium (as hydroxide and/or phosphate). Hepatitis B vaccines may contain up to 1% yeast proteins (but no yeast DNA).
The Engerix-B and H-B-Vax II vaccines are manufactured by different processes, and the HBsAg content of ‘equivalent’ doses of these 2 vaccines is different. The HBsAg content of the paediatric formulations of these 2 vaccines is half that of the corresponding manufacturer’s adult formulation.
Hepatitis B vaccines have been studied using different schedules and intervals for different age groups. Acceptable schedules are shown in the following tables and described in this section:
- Table. Monovalent hepatitis B vaccines for adolescents and adults
- Table. Accelerated hepatitis B vaccination schedules for people with imminent risk of exposure
- Table. Combination hepatitis A-hepatitis B vaccines (see also Hepatitis A)
Standard 3-dose schedule and variations
In clinical trials for DTPa-hepB-Hib-IPV vaccines, 3-dose schedules given at 2, 4 and 6 months of age were immunogenic, with more than 97% of children in the Infanrix hexa trial and 100% of children in the Vaxelis trial developing protection to hepatitis B antigen.67
A 3-dose schedule at birth, 1–2 months and 6–18 months of age is equally as immunogenic as the recommended Australian schedule above. Such schedules are often used overseas.68-70 Children born overseas who have received hepatitis B vaccine in this 3-dose schedule are considered to have completed the vaccination course.
Longer intervals between doses do not affect the immunogenicity of hepatitis B vaccine.71,72 The minimum interval between the 1st and 3rd doses of a 3-dose schedule is 4 months. This means that a shortened 3-dose schedule provided at either 0, 1, 4 months or 0, 2, 4 months is acceptable.22
A standard 3-dose schedule induces protective levels of neutralising antibody against hepatitis B virus in more than 90% of healthy adults.73 Seroconversion occurs in approximately 30–55% of people after the 1st dose, increasing to 75% of people after the 2nd dose. The 3rd dose is needed to increase the percentage of people who respond and to provide long-term protection.73,74
More compressed 3-dose schedules, such as 0, 1, 3 months, are not recommended. These compressed schedules are associated with:
- lower peak levels of antibody to hepatitis B surface antigen (anti-HBs)75,76
- likely shorter duration of antibody persistence at levels of ≥10 mIU per mL77
The clinical significance of this is uncertain.78
If a person has already received a compressed 3-dose schedule that does not meet the minimum intervals, they may not need to repeat a dose. Most people who have undetectable anti-HBs mount an anamnestic response to an additional vaccine dose. This indicates they are likely to be protected if exposed to hepatitis B virus.78
The proportion of vaccine recipients attaining seroprotective anti-HBs levels (≥10 mIU per mL) is comparable between adults who received their 3rd dose at 4–6 months after the 1st dose and those who received their 3rd dose 6 months or more after the 1st dose.79
Accelerated schedules
The interval between the 1st and 3rd doses has been shortened to <4 months in studies of 4-dose accelerated schedules. The aim is to achieve a higher seroprotective antibody level sooner.
A high proportion of vaccine recipients attain seroprotective anti-HBs levels (≥10 mIU per mL) in the early months after starting an accelerated schedule. However, antibody levels are substantially lower 7 months after an accelerated 3-dose schedule than after the standard 3-dose schedule.80
Also, some studies have shown a lower proportion of people attaining the seroprotective antibody level after 3 doses of an accelerated schedule than after the standard 3-dose schedule.80-82
An accelerated schedule requires a 4th dose at 12 months. After this dose, anti-HBs antibody levels are higher than, or comparable to, those after a standard 3-dose schedule.
Alternative 2-dose schedule for adolescents
Adolescents 11–15 years of age can receive 2 doses of adult-formulation monovalent hepatitis B vaccine 4–6 months apart. This may improve compliance in this age group, and provides comparable immunity to the 3-dose paediatric schedule.83-85
Transporting, storing and handling vaccines
Transport according to National Vaccine Storage Guidelines: Strive for 5.86 Store at +2°C to +8°C. Do not freeze. Protect from light.
Infanrix hexa must be reconstituted. Add the entire contents of the syringe to the vial and shake until the pellet completely dissolves. Use reconstituted vaccine as soon as practicable. If it must be stored, hold at room temperature for no more than 8 hours.
Public health management
Acute hepatitis B and newly identified chronic hepatitis B are notifiable diseases in all states and territories in Australia.
The Communicable Diseases Network Australia national guidelines for hepatitis B87 have details about the management of hepatitis B cases and contacts.
State and territory public health authorities can provide further advice about the public health management of hepatitis B.
Post-exposure vaccine and immunoglobulin
If an exposed person is non-immune, they will be negative for antibodies to hepatitis B surface antigen (anti-HBs) and hepatitis B core antigen (anti-HBc). If they are exposed to a source who is either positive for hepatitis B surface antigen (HBsAg) or cannot be identified and tested rapidly, the non-immune person who was exposed should receive a single dose of hepatitis B immunoglobulin (HBIG) according to Table. Post-exposure prophylaxis for non-immune people exposed to a source that is positive for hepatitis B surface antigen or has an unknown status. They should also receive hepatitis B vaccine as soon as possible, with further doses as recommended in Table. Post-exposure prophylaxis for non-immune people exposed to a source that is positive for hepatitis B surface antigen or has an unknown status.
Previously vaccinated people do not need post-exposure prophylaxis if they had a documented protective response (anti-HBs level of ≥10 mIU per mL) at any time after vaccination.
If the response to previous vaccination is unknown, determine the anti-HBs level as quickly as possible. If the anti-HBs level is <10 mIU per mL and there is no evidence of hepatitis B virus infection, the person exposed should receive HBIG and hepatitis B vaccine according to Table. Post-exposure prophylaxis for non-immune people exposed to a source that is positive for hepatitis B surface antigen or has an unknown status.
Type of exposure | Hepatitis B immunoglobulin | Vaccine | |
---|---|---|---|
Perinatal (exposure of babies during and after birth) (see Infants born to mothers who are hepatitis B surface antigen–positive are recommended to receive both hepatitis B vaccine and HBIG in Recommendations) |
|
|
|
Percutaneous, ocular or mucous membrane |
|
|
|
Sexual |
|
|
Post-exposure vaccine for healthcare workers
Non-immune healthcare workers who have had a needlestick injury or other potential hepatitis B exposure are recommended to receive a full course of hepatitis B vaccine. All healthcare workers should be immunised against hepatitis B.
Variations from product information
Routine vaccination in children and adults
Infanrix Hexa
The product information for Infanrix hexa states that this vaccine is for:
- primary immunisation of infants from the age of 6 weeks
- booster dose for children 18 months of age if they need boosting for all antigens
The Australian Technical Advisory Group on Immunisation (ATAGI) recommends that Infanrix hexa may also be used for catch-up of the primary schedule or as a booster in children <10 years of age.
Vaxelis
The product information for Vaxelis states that this vaccine is for:
- primary immunisation of infants from the age of 6 weeks
- a booster dose at least 6 months after the last priming dose
ATAGI recommends that Vaxelis may also be used for catch-up of the primary schedule or as a booster in children <10 years of age.
Contraindications
The product information for Infanrix hexa and Vaxelis states that this vaccine is contraindicated in children with either:
- encephalopathy of unknown aetiology, or
- neurologic complications occurring within 7 days after a vaccine dose
ATAGI recommends that the only contraindications are:
- anaphylaxis to a previous dose
- anaphylaxis to any of the vaccine components
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Page history
Minor update to guidance on co-administration of Vaxelis vaccine with other vaccines.
Updates throughout the chapter to reflect introduction of hexavalent Vaxelis vaccine on the National Immunisation Program.
Additionally, updates made to the Epidemiology section of the chapter.
Updates to co-administration with other vaccines to remove guidance on co-administration with MenACWY vaccine.
NCIRS request: Page - Update - Minor corrections.
Guidance on co-administration of hepatitis B-containing vaccines with quadrivalent meningococcal vaccines has been added.
Information about the seroconversion rate after a standard 3-dose schedule has been added.
Editorial changes to 'Table. Monovalent hepatitis B vaccines for adolescents and adults' in the 'Vaccines, dosage and administration' section to include paediatric formulations.
Corrected text in table describing monovalent hepatitis B vaccines for adolescents and adults.
No supporting evidence required. Editorial update due to error in table – paediatric formulations omitted.
Minor update to guidance on co-administration of Vaxelis vaccine with other vaccines.
Updates throughout the chapter to reflect introduction of hexavalent Vaxelis vaccine on the National Immunisation Program.
Additionally, updates made to the Epidemiology section of the chapter.
Updates to co-administration with other vaccines to remove guidance on co-administration with MenACWY vaccine.
NCIRS request: Page - Update - Minor corrections.
Guidance on co-administration of hepatitis B-containing vaccines with quadrivalent meningococcal vaccines has been added.
Information about the seroconversion rate after a standard 3-dose schedule has been added.
Editorial changes to 'Table. Monovalent hepatitis B vaccines for adolescents and adults' in the 'Vaccines, dosage and administration' section to include paediatric formulations.
Corrected text in table describing monovalent hepatitis B vaccines for adolescents and adults.
No supporting evidence required. Editorial update due to error in table – paediatric formulations omitted.