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* This is the Professional Version. *

Hepatitis B Vaccine

By William D. Surkis, MD; Jerome Santoro, MD

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Patient Education

For more information, see Hepatitis B ACIP Vaccine Recommendations .

Preparations

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

Single-antigen and a combination formulation that combines hepatitis A and hepatitis B vaccines (Twinrix®), are available.

Indications

HepB vaccine is a routine childhood vaccination (see Table: Recommended Immunization Schedule for Ages 0–6 yr).

HepB vaccine is indicated for people who have not been previously vaccinated when any of the following is present:

  • A desire for protection from hepatitis B in people who have not been previously vaccinated

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

  • Need for evaluation or treatment of a sexually transmitted disease (STD)

  • 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, as health care, custodial, or public safety workers)

  • Diabetes in people < 60 yr (as soon as feasible after diagnosis) and sometimes in those ≥ 60 yr (based on their 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

  • 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 STD 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 HepA and HepB vaccine can be used in people ≥ 18 yr who have indications for either hepatitis A or hepatitis B vaccine and who have not been previously vaccinated with one of the vaccine components.

Contraindications and Precautions

The main contraindication is

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

The main precaution is

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

Dose and Administration

The dose is 0.5 mL IM up to age 20 yr or 1 mL IM for adults (≥ 20 yr).

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

All children not previously vaccinated with HepB vaccine should be vaccinated at age 11 or 12 yr. A 3-dose schedule is used; the 1st and 2nd doses are separated by ≥ 4 wk, and the 3rd dose is given 4 to 6 mo after the 2nd dose. However, a 2-dose schedule using Recombivax HB® can be used; the 2nd dose is given 4 to 6 mo after the first.

The usual schedule for adults is 2 doses separated by ≥ 4 wk, and a 3rd dose 4 to 6 mo after the 2nd dose.

Unvaccinated adults who are being treated with hemodialysis or who are immunocompromised should be given 1 dose of Recombivax HB® 40 mcg/mL in a 3-dose schedule at 0, 1, and 6 mo or 2 doses of Engerix-B® 20 mcg/mL given simultaneously in a 4-dose schedule at 0, 1, 2, and 6 mo.

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

Adverse Effects

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.

* This is the Professional Version. *