Hepatitis B (HepB) Vaccine

Hepatitis B vaccine is produced using recombinant DNA technology. A plasmid containing the gene for hepatitis B surface antigen (HBsAg) is inserted into common baker’s yeast, which then produces HBsAg. The HBsAg is harvested and purified. This vaccine cannot cause hepatitis B virus infection because no potentially infectious viral DNA or complete viral particles are produced during this process.

Several vaccines are available. Two single-antigen vaccines, Engerix-B and Recombivax HB, are conjugated with aluminum. Heplisav-B (HepB-CpG) uses the immune-stimulating adjuvant, cytidine-phosphate-guanosine oligodeoxynucleotide (CpG-ODN). PreHevbrio contains the small (S), middle (pre-S2), and large (pre-S1) hepatitis B surface antigens. A combined vaccine hepatitis A vaccine/hepatitis B vaccine is also available.

HepB vaccine is a routine childhood vaccination (see CDC: Child and Adolescent Immunization Schedule by Age).

HepB vaccine also is indicated for all adults aged 19 through 59 years who have not been previously vaccinated (see CDC: Adult Immunization Schedule by Age).

HepB vaccine also is indicated for adults aged 60 years and older who have not been previously vaccinated and who have any of the following:

• A desire for protection from hepatitis B

• A sexually active lifestyle in people who are not in a long-term, mutually monogamous relationship (eg, > 1 sex partner during the previous 6 months)

• Need for evaluation or treatment of a sexually transmitted infection

• Current or recent use of illicit injection drugs

• Sex between men

• Employment in which workers may be exposed to blood or other potentially infectious body fluids (eg, health care, custodial, or public safety workers)

• Diabetes in people < 60 years (as soon as feasible after diagnosis) and sometimes in those ≥ 60 years (based on shared clinical decision-making between clinician and patient regarding the risk of becoming infected, having severe consequences if infected, and having an adequate immune response to vaccination)

• End-stage renal disease (eg, being treated with hemodialysis)

• HIV infection

• A chronic liver disorder (eg, people with hepatitis C, cirrhosis, fatty liver disease, alcohol-related liver disease, autoimmune hepatitis, or alanine aminotransferase [ALT] or aspartate aminotransferase [AST] level greater than twice the upper limit of normal)

• Household contact and/or sexual contact with people who are positive for hepatitis B surface antigen (HBsAg)

• Travel to endemic areas

• Time spent (as patients, residents, or employees) in correctional facilities or in facilities that provide sexually transmitted infection treatment, HIV testing and treatment, drug abuse treatment and prevention services, services to injection-drug users or men who have sex with men, or care for patients with developmental disabilities or with end-stage renal disease (including those receiving long-term hemodialysis)

The combination hepatitis A vaccine/hepatitis B vaccine can be used in people ≥ 18 years who have indications for either hepatitis A or hepatitis B vaccine and who have not been previously vaccinated with one of the vaccine components.

The main contraindication for hepatitis B vaccine is

• A severe allergic reaction (eg, anaphylaxis) after previous dose or to baker's yeast or any vaccine component

The main precaution with HepB vaccine is

• Moderate or severe illness with or without a fever (vaccination is postponed until the illness resolves)

The dose for Engerix-B and Recombivax HB is 0.5 mL IM up to age 20 years or 1 mL IM for adults (≥ 20 years). The dose for Heplisav-B (HepB-CpG) is 0.5 mL IM for adults ≥ 18 years. The dose for PreHevbrio is 1.0 mL IM for adults ≥ 18 years.

The vaccine is typically given to children in a 3-dose series at age 0 months, at 1 to 2 months, and at 6 to 18 months.

Infants who did not receive a dose a birth should begin the series as soon as feasible.

All children not previously vaccinated with HepB vaccine should be vaccinated at age 11 or 12 years. A 3-dose schedule is used; the first and second doses are separated by ≥ 4 weeks, and the third dose is given 4 to 6 months after the second dose. However, a 2-dose schedule using Recombivax HB can be used; the second dose is given 4 to 6 months after the first.

Adults age 19 through 59 years who have not been previously vaccinated should complete a 2- or 3-, or 4-dose series. The usual schedule for adults using Engerix-B, PreHevbrio, or Recombivax HB is a 3-dose series with 2 doses separated by ≥ 4 weeks, and a third dose 4 to 6 months after the second dose. Heplisav-B (HepB-CpG) is given in 2 doses at least 4 weeks apart and can be given as a substitute in a 3-dose series with a different HepB vaccine.

Heplisav-B (HepB-CpG) and PreHevbrio should not be given during pregnancy because safety data are not available on its use during pregnancy.

Unvaccinated adults who are being treated with hemodialysis should be given Engerix-B (using 2 mL dose instead of the normal adult dose of 1 mL) in a 4-dose schedule at 0, 1, 2, and 6 months or Recombivax HB Dialysis Formulation (1 mL = 40 mcg) in a 3-dose series at 0, 1, 6 months.

If people are not vaccinated or not completely vaccinated, the missing doses should be given to complete the 3-dose HepB series. The second dose is given 1 month after the first dose; the third dose is given ≥ 2 months after the second dose (and ≥ 4 months after the first dose). If the combined hepatitis A and hepatitis B vaccine is used, 3 doses are given at 0, 1, and 6 months, or 4 doses are given on days 0, 7, and 21 to 30, followed by a booster dose at 12 months. If a person was lost to follow-up before the series was completed, the series does not need to be restarted.

Serious adverse effects are very rare and include anaphylaxis.

Mild effects include pain at the injection site and occasionally an increase in temperature to about 38° C.

The following English-language resources may be useful. Please note that THE MANUAL is not responsible for the content of these resources.

1. Advisory Committee on Immunization Practices (ACIP): Hepatitis B ACIP Vaccine Recommendations

2. ACIP: Recommended Adult Immunization Schedule, United States, 2023 including Changes to the 2023 Adult Immunization Schedule

3. Centers for Disease Control and Prevention (CDC): Hepatitis B Vaccination: Information for Healthcare Providers

4. European Centre for Disease Prevention and Control (ECDC): Hepatitis B: Recommended vaccinations