The hepatitis B vaccine is 80 to 100% effective in preventing infection or clinical hepatitis B Hepatitis B, Acute Hepatitis B is caused by a DNA virus that is often parenterally transmitted. It causes typical symptoms of viral hepatitis, including anorexia, malaise, and jaundice. Fulminant hepatitis and... read more 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. For a summary of changes to the 2023 adult immunization schedule, see the Advisory Committee on Immunization Practices Recommended Adult Immunization Schedule, United States, 2023: Changes to the 2023 Adult Immunization Schedule.
(See also Overview of Immunization Overview of Immunization Immunity can be achieved Actively by using antigens (eg, vaccines, toxoids) Passively by using antibodies (eg, immune globulins, antitoxins) A toxoid is a bacterial toxin that has been modified... read more .)
Preparations of Hepatitis B 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.
Indications for Hepatitis B Vaccine
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.
Contraindications and Precautions for Hepatitis B Vaccine
The main contraindication for hepatitis B vaccine is
A severe allergic reaction (eg, anaphylaxis Anaphylaxis Anaphylaxis is an acute, potentially life-threatening, IgE-mediated allergic reaction that occurs in previously sensitized people when they are reexposed to the sensitizing antigen. Symptoms... read more ) 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 (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.
Adverse Effects of Hepatitis B Vaccine
Serious adverse effects are very rare and include anaphylaxis Anaphylaxis Anaphylaxis is an acute, potentially life-threatening, IgE-mediated allergic reaction that occurs in previously sensitized people when they are reexposed to the sensitizing antigen. Symptoms... read more .
Mild effects include pain at the injection site and occasionally an increase in temperature to about 38° C.
More Information
The following English-language resources 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
ACIP: Recommended Adult Immunization Schedule, United States, 2023 including Changes to the 2023 Adult Immunization Schedule
Centers for Disease Control and Prevention (CDC): Hepatitis B Vaccination: Information for Healthcare Providers
European Centre for Disease Prevention and Control (ECDC): Hepatitis B: Recommended vaccinations
Drugs Mentioned In This Article
| Drug Name | Select Trade |
|---|---|
hepatitis b vaccine |
Engerix-B, Engerix-B Pediatric, H-B-Vax, HEPLISAV-B, PreHevbrio, RDNA H-B Vax II, Recombivax HB, Recombivax HB Pediatric/Adolescent |
hepatitis a vaccine/hepatitis b vaccine |
Twinrix |
