Primary prevention

Primary prevention can be via passive immunization with hepatitis B immune globulin (HBIG) or via active immunization with hepatitis B vaccine (recombinant inactive hepatitis B surface antigen [HBsAg]).

Infants, children, and adolescents ≤18 years

  • The World Health Organization recommends that all infants should receive a hepatitis B vaccine series, with the first dose given as soon as possible after birth, preferably within 24 hours, followed by two or three doses administered according to national routine immunization schedules.​​[65]​​

    • The monovalent vaccine should be used for the birth dose, while monovalent or combined vaccines can be used in infants aged >6 weeks.

  • In the US, the Advisory Committee on Immunization Practices (ACIP) recommends babies receive a first dose of hepatitis B vaccine within 24 hours of birth, with a second dose at 1-2 months (minimum interval after first dose of 4 weeks), and a third dose at 6-18 months (at least 8 weeks after the second dose and at least 16 weeks after the first dose). If no dose is given at birth, then three doses of a hepatitis B-containing vaccine should be given on a schedule of 0, 1-2, and 6 months, starting as soon as possible. A four-dose series is permitted when a combination vaccine containing hepatitis B is administered after the birth dose. The final (third or fourth) dose should be administered no earlier than the age of 24 weeks. The monovalent vaccine should be used for doses administered before age 6 weeks.​​[66]​​​

    • Babies born to HBsAg-positive mothers should receive both hepatitis B vaccine (monovalent vaccine only) and HBIG (in separate limbs) within 12 hours of birth, regardless of birth weight. Babies <2000 g should receive three additional doses of vaccine (total of four doses), beginning at age 1 month. Babies should be tested for HBsAg and antibody to hepatitis B surface antigen at age 9-12 months, or if vaccination is delayed, at 1-2 months after completion of hepatitis B vaccine series.

    • Babies born to mothers with an unknown HBsAg status should receive hepatitis B vaccine within 12 hours of birth regardless of birth weight, and those weighing <2000 g should also receive HBIG (in separate limbs) and three additional doses of vaccine (total of four doses), beginning at age 1 month. For babies weighing ≥2000 g, the mother’s HBsAg status should be determined as soon as possible and, if positive, HBIG given to the baby as soon as possible and within 7 days. If there is evidence to suggest maternal hepatitis B infection, manage infants as if the mother is HBsAg-positive.

    • Babies born to HBsAg-negative mothers should receive one dose of hepatitis B vaccine within 24 hours of birth if medically stable and birth weight is ≥2000 g. Babies <2000 g should receive one dose at chronological age 1 month or hospital discharge (whichever is earlier, even if weight is still <2000 g).

    • Catch-up vaccination: children and adolescents who have not previously received the hepatitis B vaccine should receive the standard schedule of three vaccinations at 0, 1-2, and 6 months. Adolescents ages 11-15 years may receive an alternative two-dose series of adult Recombivax HB® with at least 4 months between doses. Adolescents ages ≥18 years may receive a two-dose series of Heplisav-B® at least 4 weeks apart, a three-dose series of PreHevbrio® at 0, 1, and 6 months, or the combined hepatitis A and hepatitis B vaccine (Twinrix®) as a three- or four-dose series.

  • The American College of Obstetricians and Gynecologists (ACOG) supports the recommendation that neonates of HBsAg-positive mothers (or whose status is unknown at the time of delivery), receive both hepatitis B vaccination and HBIG within 12 hours of birth.[67]

  • The global coverage with the third dose of hepatitis B vaccine was between 82% and 85% between 2016 and 2020. Coverage was ≥90% for both the birth dose and the 3-dose series in 41% of countries with data available in 2020.[18]

  • Immunization schedules differ between countries. Consult your local immunization protocols for more information.

Adults

  • In the US, ACIP recommends universal vaccination in adults ages 19-59 years with a two-, three-, or four-dose series. Adults ≥60 years of age with known risk factors for infection (see below) should receive a complete vaccine series. Adults ≥60 years of age without known risk factors may receive a complete vaccine series if they choose to or request it. The dose schedule depends on the vaccine used (e.g., Engerix-B®, Recombivax HB®, Heplisav-B®, Twinrix®, PreHevbrio®). Consult the immunization schedule for more detailed information. Adults ≥60 years of age with diabetes should receive vaccination based on shared clinical decision-making.[68]​​​

  • At-risk populations include:

    • People with chronic liver disease (e.g., hepatitis C, cirrhosis, fatty liver disease, alcoholic liver disease, autoimmune hepatitis, alanine aminotransferase or aspartate aminotransferase level greater than twice upper limit of normal)

    • People with HIV infection or current or recent injection drug use

    • People with a sexual exposure risk (e.g., sex partners of HBsAg-positive people, sexually active people not in mutually monogamous relationships, men who have sex with men, people seeking evaluation or treatment of sexually transmitted infection)

    • People with percutaneous or mucosal risk for exposure to blood (e.g., patients with diabetes, dialysis patients, household contacts of HBsAg-positive people, healthcare personnel)

    • Incarcerated people

    • People traveling to countries with high or intermediate endemic hepatitis B.

  • ACOG supports the use of the hepatitis B vaccine with an appropriate vaccine during pregnancy for recommended patient groups.[67]

  • Immunization schedules differ between countries. Consult your local immunization protocols for more information.

The table that follows summarizes recommendations for primary prevention of hepatitis B taken from the Centers for Disease Control and Prevention (CDC) immunization schedules.[66]​​​​[68]​​

Note that an individual patient may fall into more than one group and so interventions might be additive; please review all population and subpopulation groups to assess all that apply.

Neonate

Born to HBsAg-negative mother; birth weight ≥2000 g

Intervention
Goal
Intervention

Hepatitis B vaccination; three-dose series; first dose given within 24 hours of birth

A three-dose series (given at 0 months, 1-2 months, and 6-18 months) is recommended.

The first dose is recommended within 24 hours of birth, if medically stable.

Administration of four doses is permitted when a combination vaccine containing hepatitis B is used after the birth dose.

Do not give the final (third or fourth) dose earlier than the age of 24 weeks.

Only the monovalent vaccine is recommended for doses administered before age 6 weeks.

Goal

Immunity against hepatitis B infection

Lifelong protection against hepatitis B is assumed following completion of vaccination series; post-vaccination serology testing and revaccination is not recommended for children with a normal immune status, but it is recommended in certain populations, including:

  • children who are predialysis or on maintenance dialysis; or

  • other immunocompromised children.

The following minimum intervals apply:

  • Dose one to dose two: 4 weeks

  • Dose two to dose three: 8 weeks (and at least 16 weeks after dose one)

  • [Optional: dose three to dose four: 8 weeks (and at least 16 weeks after dose two)].

Born to HBsAg-negative mother; birth weight <2000 g

Intervention
Goal
Intervention

Hepatitis B vaccination; three-dose series; deferred first dose

A three-dose series (given at 0 months, 1-2 months, and 6-18 months) is recommended.

The first dose is recommended at chronological age 1 month or hospital discharge (whichever is earlier, even if weight is still <2000 g).

Administration of four doses is permitted when a combination vaccine containing hepatitis B is used after the birth dose.

Do not give the final (third or fourth) dose earlier than the age of 24 weeks.

Only the monovalent vaccine is recommended for doses administered before age 6 weeks.

Goal

Immunity against hepatitis B infection

Lifelong protection against hepatitis B is assumed following completion of vaccination series; post-vaccination serology testing and revaccination is not recommended for children with a normal immune status, but it is recommended in certain populations, including:

  • children who are predialysis or on maintenance dialysis; or

  • other immunocompromised children.

The following minimum intervals apply:

  • Dose one to dose two: 4 weeks

  • Dose two to dose three: 8 weeks (and at least 16 weeks after dose one)

  • [Optional: dose three to dose four: 8 weeks (and at least 16 weeks after dose two)].

Born to HBsAg-positive mother, or mother with unknown HBsAg status with evidence suggestive of maternal hepatitis B infection; birth weight ≥2000 g

Intervention
Goal
Intervention

Hepatitis B vaccination; three-dose series; first dose given concurrently with HBIG within 12 hours of birth

If HBsAg status is unknown, evidence suggestive of maternal hepatitis B infection includes:

  • Presence of hepatitis B virus (HBV) DNA

  • HBeAg-positive status

  • Where the mother is known to have chronic hepatitis B infection.

Manage these infants as if the mother is HBsAg positive.

The first dose is recommended within 12 hours of birth, with HBIG given concurrently in a separate limb.

Administration of four doses is permitted when a combination vaccine containing hepatitis B is used after the birth dose.

A three-dose series is recommended, with the final (third or fourth) dose given at age 6 months (minimum age 24 weeks).

Only the monovalent vaccine is recommended for doses administered before age 6 weeks.

Goal

Immunity against hepatitis B infection

Confirmation of immunity against hepatitis B infection is needed; otherwise, revaccination is required.

Babies should be tested for HBsAg and hepatitis B surface antibodies (anti-HBs) at age 9-12 months or, if vaccination is delayed, at 1-2 months after completion of hepatitis B vaccine series.

Revaccination is recommended if anti-HBs <10 mlU/mL.

The following minimum intervals apply:

  • Dose one to dose two: 4 weeks

  • Dose two to dose three: 8 weeks (and at least 16 weeks after dose one)

  • [Optional: dose three to dose four: 8 weeks (and at least 16 weeks after dose two)].

Born to HBsAg-positive mother, or mother with unknown HBsAG status but with evidence suggestive of maternal hepatitis B infection; birth weight <2000 g

Intervention
Goal
Intervention

Hepatitis B vaccination; four-dose series; first dose given concurrently with HBIG within 12 hours of birth

If HBsAg status is unknown, evidence suggestive of maternal hepatitis B infection includes:

  • Presence of HBV DNA

  • HBeAg-positive status

  • Where the mother is known to have chronic hepatitis B infection.

Manage these infants as if the mother is HBsAg positive.

The first dose is recommended within 12 hours of birth, with HBIG given concurrently in a separate limb.

A four-dose series is recommended, with the second dose given at age 1 month and the fourth dose administered at age 6 months (minimum age 24 weeks).

Only the monovalent vaccine is recommended for doses administered before age 6 weeks.

Goal

Immunity against hepatitis B infection

Confirmation of immunity against hepatitis B infection is needed; otherwise, revaccination is required.

Babies should be tested for HBsAg and anti-HBs at age 9-12 months or, if vaccination is delayed, at 1-2 months after completion of hepatitis B vaccine series.

Revaccination is recommended if anti-HBs <10 mlU/mL.

The following minimum intervals apply:

  • Dose one to dose two: 4 weeks

  • Dose two to dose three: 8 weeks (and at least 16 weeks after dose one)

  • Dose three to dose four: 8 weeks (and at least 16 weeks after dose two).

Born to mother with unknown HBsAg status; no evidence suggestive of maternal hepatitis B infection; birth weight ≥2000 g

Intervention
Goal
Intervention

Hepatitis B vaccination; three-dose series; first dose within 12 hours of birth; HBIG within 7 days if mother is determined to be HBsAg-positive

If HBsAg status is unknown, evidence suggestive of maternal hepatitis B infection includes:

  • Presence of HBV DNA

  • HBeAg-positive status

  • Where the mother is known to have chronic hepatitis B infection.

In the absence of any of the above factors, manage the infant according to the advice here for babies born to mothers with unknown HBsAg status.

The first dose is recommended within 12 hours of birth. If the mother is determined to be HBsAg-positive, administer HBIG as soon as possible (in a separate limb), but no later than 7 days of age.

Administration of four doses is permitted when a combination vaccine containing hepatitis B is used after the birth dose.

A three-dose series is recommended, with the final (third or fourth) dose given at age 6 months (minimum age 24 weeks).

Only the monovalent vaccine is recommended for doses administered before age 6 weeks.

Goal

Immunity against hepatitis B infection

Mother determined to be HBsAg-negative:

Lifelong protection against hepatitis B is assumed following completion of vaccination series. Post-vaccination serology testing and revaccination is not recommended for children with a normal immune status, but it is recommended in certain populations, including:

  • children who are predialysis or on maintenance dialysis; or

  • other immunocompromised children.

Mother determined to be HBsAg-positive, or if status remains unknown:

Babies should be tested for HBsAg and anti-HBs at age 9-12 months or, if vaccination is delayed, at 1-2 months after completion of hepatitis B vaccine series.

Revaccination is recommended if anti-HBs <10 mlU/mL.

Born to mother with unknown HBsAg status; no evidence suggestive of maternal hepatitis B infection; birth weight <2000 g

Intervention
Goal
Intervention

Hepatitis B vaccination; four-dose series; first dose given concurrently with HBIG within 12 hours of birth

If HBsAg status is unknown, evidence suggestive of maternal hepatitis B infection includes:

  • Presence of HBV DNA

  • HBeAg-positive status

  • Where the mother is known to have chronic hepatitis B infection.

In the absence of any of the above factors, manage the infant as per the advice here for babies born to mothers with unknown HBsAg status.

The first dose is recommended within 12 hours of birth, with HBIG given concurrently in a separate limb.

A four-dose series is recommended, with the second dose given at age 1 month and the fourth dose administered at age 6 months (minimum age 24 weeks).

Only the monovalent vaccine is recommended for doses administered before age 6 weeks.

Goal

Immunity against hepatitis B infection

Mother determined to be HBsAg-negative:

Lifelong protection against hepatitis B is assumed following completion of vaccination series. Post-vaccination serology testing and revaccination is not recommended for children with a normal immune status, but it is recommended in certain populations, including:

  • children who are predialysis or on maintenance dialysis; or

  • other immunocompromised children.

Mother determined to be HBsAg-positive, or if status remains unknown:

Testing of the baby is recommended for HBsAg and anti-HBs at age 9-12 months or, if vaccination is delayed, at 1-2 months after completion of hepatitis B vaccine series.

Revaccination is recommended if anti-HBs <10 mlU/mL.

Child or adolescent ages 0-10 years; not yet vaccinated

All

Intervention
Goal
Intervention

Catch-up hepatitis B vaccination; three-dose series

It is recommended that children and adolescents who have not previously received hepatitis B vaccination should receive a three-dose series, with the first dose given as soon as possible (given at 0 months, 1-2 months, and 6-18 months).

Do not give the final third dose earlier than the age of 24 weeks.

Only the monovalent vaccine is recommended for doses administered before age 6 weeks.

Goal

Immunity against hepatitis B infection

Lifelong protection against hepatitis B is assumed following completion of vaccination series. Post-vaccination serology testing and revaccination is not recommended for children and adolescents with a normal immune status, but it is recommended in certain populations, including:

  • children who are predialysis or on maintenance dialysis; or

  • other immunocompromised children.

The following minimum intervals apply:

  • Dose one to dose two: 4 weeks

  • Dose two to dose three: 8 weeks (and at least 16 weeks after dose one).

Child or adolescent ages 11-18 years; not yet vaccinated

All

Intervention
Goal
Intervention

Catch-up hepatitis B vaccination; vaccination schedules vary

It is recommended that children and adolescents who have not previously received hepatitis B vaccination should receive a three-dose series, with the first dose given as soon as possible (given at 0 months, 1-2 months, and 6-18 months).

Children and adolescents ages 11-15 years may receive an alternative two-dose series of adult Recombivax HB® with at least 4 months between doses.

Adolescents ages 18 years may receive:

  • an alternative two-dose series of Heplisav-B® at least 4 weeks apart

  • an alternative three-dose series of PreHevbrio® at 0, 1, and 6 months; or

  • the combined hepatitis A and hepatitis B vaccine (Twinrix®) as a three- or four-dose series.

PreHevbrio® is not recommended in pregnancy due to lack of safety data in pregnancy.

Goal

Immunity against hepatitis B infection

Lifelong protection against hepatitis B is assumed following completion of vaccination series. Post-vaccination serology testing and revaccination is not recommended for children and adolescents with a normal immune status, but it is recommended in certain populations, including:

  • children who are predialysis or on maintenance dialysis; or

  • other immunocompromised children.

The following minimum intervals apply:

  • Dose one to dose two: 4 weeks

  • Dose two to dose three: 8 weeks (and at least 16 weeks after dose one)

  • Dose three to dose four: 8 weeks (and at least 16 weeks after dose two).

Unvaccinated adult; ages 19-59 years

All

Intervention
Goal
Intervention

Catch up hepatitis B vaccination; vaccination schedules vary

Universal vaccination is recommended for unvaccinated adults ages 19-59 years; options include a two-, three-, or four-dose series.

The dose schedule depends on the vaccine used (e.g., Engerix-B®, Recombivax HB®, Heplisav-B®, Twinrix®, PreHevbrio®).

Consult the immunization schedule for further information.

PreHevbrio® is not recommended in pregnancy due to lack of safety data in pregnant women.

Goal

Immunity against hepatitis B infection

Post-vaccination serology testing and revaccination is not recommended for adults.

Recommended minimum intervals between doses vary according to the schedule used.

On dialysis

Intervention
Goal
Intervention

Catch up hepatitis B vaccination; three- or four-dose series

Universal vaccination is recommended for unvaccinated adults ages 19-59 years, including those on dialysis.

Dialysis represents a special situation for hepatitis B vaccination.

A three- or four-dose series is recommended for people receiving dialysis; either:

  • a three-dose series with Recombivax HB® at 0, 1, and 6 months; or

  • a four-dose series with Engerix-B® at 0, 1, 2, and 6 months.

Note that dialysis-specific formulations and doses apply depending on the series used; consult the immunization schedule and prescribing information.

Goal

Immunity against hepatitis B infection

Post-vaccination serology testing and revaccination is not recommended for adults.

Recommended minimum intervals between doses vary according to the schedule used.

Unvaccinated adult; ages ≥60 years; with known risk factors for hepatitis B infection, or who request hepatitis B vaccination

Risk factors for hepatitis B include: chronic liver disease; HIV infection; sexual exposure risk; current or recent injection drug use; percutaneous or mucosal risk for exposure to blood; incarceration; travel in countries with high or intermediate endemic hepatitis B. Adults ages ≥60 years with diabetes may receive vaccination based on shared clinical decision-making.

All

Intervention
Goal
Intervention

Catch up hepatitis B vaccination; vaccination schedules vary

It is recommended that adults ages ≥60 years with known risk factors for hepatitis B, as well as those who request hepatitis B vaccination, receive a hepatitis B vaccination series.

Those ages ≥60 years without known risk factors for hepatitis B may receive a hepatitis B vaccination series.

Options include either a two-, three-, or four-dose series.

The dose schedule depends on the vaccine used (e.g., Engerix-B®, Recombivax HB®, Heplisav-B®, Twinrix®, PreHevbrio®).

Consult the immunization schedule for further information.

Goal

Immunity against hepatitis B infection

Post-vaccination serology testing and revaccination is not recommended for adults.

Recommended minimum intervals between doses vary according to the schedule used.

On dialysis

Intervention
Goal
Intervention

Catch up hepatitis B vaccination; three- or four-dose series

Dialysis represents a special situation for hepatitis B vaccination.

A three- or four-dose series is recommended for people receiving dialysis, either:

  • a three-dose series with Recombivax HB® at 0, 1, and 6 months; or

  • a four-dose series with Engerix-B® at 0, 1, 2, and 6 months.

Note that dialysis-specific formulations and doses apply depending on the series used; consult the immunization schedule and prescribing information.

Goal

Immunity against hepatitis B infection

Post-vaccination serology testing and revaccination is not recommended for adults.

Recommended minimum intervals between doses vary according to the schedule used.

Secondary prevention

The following secondary prevention measures are recommended:[3]​​[39]

  • Screen pregnant women for hepatitis B surface antigen (HBsAg). Pregnant women should also be encouraged to discuss the need for maternal antiviral therapy, as well as newborn hepatitis B vaccination and hepatitis B immune globulin (HBIG), with their obstetrician to prevent mother-to-child transmission.

  • Advise healthcare workers with HBV infection who perform exposure-prone procedures to seek counseling and advice from an expert review panel, as antiviral prophylaxis may be recommended.

  • Initiate antiviral prophylaxis in patients who are starting on immunosuppressive therapy (including chemotherapy or immunotherapy) to prevent hepatitis B reactivation.

  • Initiate lifelong antiviral prophylaxis with a nucleoside/nucleotide analog (with or without HBIG) in all HBsAg-positive patients undergoing liver transplantation, regardless of pretransplant hepatitis B e antigen status or HBV DNA level. An individualized approach to HBIG use is recommended.

  • Initiate long-term antiviral therapy in HBsAg-negative patients receiving livers from donors with evidence of past HBV infection (antibody to hepatitis B core antigen-positive) to prevent HBV reactivation.

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