The hepatitis B vaccine is 80 to 100% effective in preventing infection or clinical hepatitis B in people who complete the vaccine series.
For more information, see Hepatitis B Advisory Committee on Immunization Practices Vaccine Recommendations and Centers for Disease Control and Prevention (CDC): Hepatitis B Vaccination. A summary of changes to the 2021 adult immunization schedule is available here.
(See also Overview of Immunization.)
Preparations of Hepatitis B Vaccine
Hepatitis B (HepB) 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.
Single-antigen and a combination formulation that combines hepatitis A and hepatitis B vaccines (Twinrix®) are available. Two single-antigen vaccines, Engerix-B® and Recombivax HB®, are conjugated with aluminum. A newer formulation, HepB-CpG (Heplisav-B®), uses the immune-stimulating adjuvant, cytidine-phosphate-guanosine oligodeoxynucleotide (CpG-ODN).
Indications for Hepatitis B Vaccine
HepB vaccine is a routine childhood vaccination (see Table: Recommended Immunization Schedule for Ages 0–6 Years).
HepB vaccine also is indicated for adults 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 months)
- Need for evaluation or treatment of a sexually transmitted disease
- 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 disease 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)
- Pregnant women if at risk of infection or severe outcome resulting from infection during pregnancy (Heplisav-B® not currently recommended due to lack of safety data in pregnant women)
The combination HepA and HepB 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.
Contraindications and Precautions of Hepatitis B Vaccine
The main contraindication for HepB 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)
Dose and Administration of Hepatitis B Vaccine
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® is 0.5 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 1st and 2nd doses are separated by ≥ 4 weeks, and the 3rd dose is given 4 to 6 months after the 2nd dose. However, a 2-dose schedule using Recombivax HB® can be used; the 2nd dose is given 4 to 6 months after the first.
The usual schedule for adults using Engerix-B® or Recombivax HB® is a 3-dose series with 2 doses separated by ≥ 4 weeks, and a 3rd dose 4 to 6 months after the 2nd dose. Heplisav-B® 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® 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 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 months or 2 doses of Engerix-B® 20 mcg/mL given simultaneously in a 4-dose schedule at 0, 1, 2, and 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 2nd dose is given 1 month after the 1st dose; the 3rd dose is given ≥ 2 months after the 2nd dose (and ≥ 4 months 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 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.
Adverse Effects of Hepatitis B Vaccine
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 are some English-language resources that may be useful. Please note that THE MANUAL is not responsible for the content of these resources.
- Advisory Committee on Immunization Practices (ACIP): Hepatitis B ACIP Vaccine Recommendations
- Centers for Disease Control and Prevention (CDC): Hepatitis B Vaccination: Information for Healthcare Providers
- Summary of changes to the 2021 adult immunization schedule