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Ask the Experts: Hepatitis B

Results (114)

About 30%–50% people who are 5 years of age or older with acute (recently acquired) hepatitis B have initial signs or symptoms when infected with hepatitis B virus (HBV). Children younger than age 5 years and newly infected immunosuppressed adults rarely show any symptoms. When present, signs and symptoms of hepatitis B might include nausea, lack of appetite, tiredness, muscle, joint, or abdominal pain, fever, diarrhea or vomiting, headache, dark urine, clay-colored stools, and yellowing of the skin and whites of the eyes (jaundice). People who have such signs or symptoms generally feel quite ill and might need to be hospitalized. People with chronic (life-long) HBV infection might have no symptoms, have no evidence of liver disease, or have a range of disease from chronic hepatitis to cirrhosis or hepatocellular carcinoma, a type of liver cancer.

Last reviewed: July 21, 2023

If signs or symptoms of illness occur, they begin an average of 90 days (range: 60–150 days) after exposure to HBV.

Last reviewed: July 21, 2023

Persons with chronic HBV infection (those with persistent hepatitis B surface antigen [HBsAg] in the serum for at least 6 months) serve as the main reservoir for HBV transmission.

HBV is transmitted through percutaneous (through the skin), mucosal, or non-intact skin exposure to infectious blood or body fluids. HBV is concentrated most highly in blood, and percutaneous exposure is an efficient mode of transmission. Semen and vaginal secretions are infectious, and HBV also can be detected in saliva, tears, and bile. Cerebrospinal fluid, synovial fluid, pleural fluid, peritoneal fluid, pericardial fluid, and amniotic fluid are also considered potentially infectious. Urine, feces, vomitus, nasopharyngeal washings, sputum, and sweat are not efficient vehicles of transmission unless they contain blood because they contain low quantities of infectious HBV. Hepatitis B surface antigen (HBsAg) found in breast milk is also unlikely to lead to transmission so HBV infection is not a contraindication to breastfeeding.

Among adults in the U.S., HBV is transmitted primarily by percutaneous exposure to blood (for example, injection drug use) and sexual contact. HBV is transmitted efficiently by sexual contact both among heterosexuals and among men who have sex with men (MSM). Transmission can occur from interpersonal contact (e.g., sharing a toothbrush or razor, contact with exudates from dermatologic lesions, or contact with HBsAg-contaminated surfaces) and in settings such as schools, child care centers, and facilities for developmentally disabled persons. Transmission of HBV from transfusion of blood or blood products is rare because of donor screening and viral inactivation procedures. Other possible sources of infection include contaminated medical or dental instruments, unsafe injections, needle-stick injuries, organ transplantation, and dialysis.

In 2019, a total of 3,192 cases of acute hepatitis B were reported to CDC, corresponding to 20,700 estimated acute infections (based on the estimated ratio of acute cases reported to actual acute cases). The most commonly reported risk behaviors and exposures were injection drug use (35%), multiple sex partners (23%), and surgery (10%), followed by other sexual and bloodborne risk behaviors; risk behavior and exposure information were missing for 37.1% of cases.

Last reviewed: July 21, 2023

Yes. Even though tattooing and body piercing are not thought to be a significant mode of transmission for HBV, tattooing and body piercing have the potential to transmit bloodborne infections, including HBV, hepatitis C virus (HCV), and human immunodeficiency virus (HIV), if the person doing the tattoos or body piercing does not use good infection control practices. The Centers for Disease Control and Prevention (CDC) recommends that instruments or materials (including ink), intended to penetrate the skin be used once, then disposed of or thoroughly cleaned and sterilized between clients. Personal service workers who do tattooing or body piercing should be educated about the transmission of bloodborne pathogens and what precautions are needed to prevent transmission.

People considering getting a tattoo or having a body part pierced should ask staff at the establishment what procedures they use to prevent the spread of bloodborne infections. They also might call the local health department to find out what sterilization procedures are required by law or ordinance for tattooing and body piercing establishments.

Last reviewed: July 21, 2023

There are no specific data on transmission of bloodborne viruses through oral-genital sex. Saliva has not been associated with HBV transmission unless biting has taken place. HBV is not spread by kissing, hugging, sneezing, coughing, food or water, sharing eating utensils or drinking glasses, or casual contact.

Last reviewed: July 21, 2023

Generally speaking, no. A person with laboratory evidence of resolved hepatitis B infection is considered immune. Vaccination of such individuals is not harmful but is not necessary.

Last reviewed: July 21, 2023

HBV is stable in the environment and remains viable for 7 or more days on environmental surfaces at room temperature. HBV can be transmitted despite the absence of visible blood. Any high level disinfectant that is tuberculocidal will inactivate HBV. The Environmental Protection Agency also registers disinfectants specifically approved for use against HIV and HBV; a current list is available at this website: www.epa.gov/pesticide-registration/list-d-epas-registered-antimicrobial-products-effective-against-human-hiv-1.

Last reviewed: July 21, 2023
Table 1: Hepatitis B laboratory nomenclature
HBsAg: Hepatitis B surface antigen is a marker of infectivity. Its presence indicates either acute or chronic HBV infection.
anti-HBs: Antibody to hepatitis B surface antigen is a marker of immunity. Its presence indicates an immune response to HBV infection, an immune response to vaccination, or the presence of passively acquired antibody. (It is also known as HBsAb, but this abbreviation is best avoided since it is often confused with abbreviations such as HBsAg.)
anti-HBc (total): Antibody to hepatitis B core antigen is a nonspecific marker of acute, chronic, or resolved HBV infection. It is not a marker of vaccine-induced immunity. It may be used in prevaccination testing to determine previous exposure to HBV infection. (It is also known as HBcAb, but this abbreviation is best avoided since it is often confused with other abbreviations.)
IgM anti-HBc: IgM antibody subclass of anti-HBc. Positivity indicates recent infection with HBV (<6 mos). Its presence indicates acute infection.
HBeAg: Hepatitis B “e” antigen is a marker of a high degree of HBV infectivity, and it correlates with a high level of HBV replication. It is primarily used to help determine the clinical management of patients with chronic HBV infection.
Anti-HBe: Antibody to hepatitis B “e” antigen may be present in an infected or immune person. In persons with chronic HBV infection, its presence suggests a low viral titer and a low degree of infectivity.
HBV-DNA: HBV Deoxyribonucleic acid is a measure of viral load and reflects viral replication. It correlates well with infectivity. It is used to assess and monitor the treatment of patients with chronic HBV infection.
Last reviewed: July 21, 2023
Table 2
Tests Results Interpretation Vaccinate?
HBsAg
anti-HBc
anti-HBs		 negative
negative
negative		 susceptible vaccinate if indicated
HBsAg
anti-HBc
anti-HBs		 negative
negative
positive with >10mIU/mL*		 immune due to vaccination (or may represent passive transfer of antibodies from receipt of HBIG) no vaccination necessary
HBsAg
anti-HBc
IgM anti-HBc
anti-HBs		 negative
positive
negative
positive		 immune due to natural infection no vaccination necessary
HBsAg
anti-HBc
IgM anti-HBc
anti-HBs		 negative
positive
positive
positive		 acute resolving infection no vaccination necessary
HBsAg
anti-HBc
IgM anti-HBc
anti-HBs		 positive
positive
positive
negative		 acutely infected no vaccination necessary
HBsAg
anti-HBc
IgM anti-HBc
anti-HBs		 positive
positive
negative
negative		 chronically infected no vaccination necessary (may need treatment)
HBsAg
anti-HBc
anti-HBs		 negative
positive
negative		 four interpretations possible† use clinical judgment

* Postvaccination testing, when it is recommended, should be performed 1-2 months after the last dose of vaccine. Infants born to HBsAg-positive mothers should be tested for HBsAg and anti-HBs after completion of at least 3 doses of a licensed hepatitis B vaccination series, at age 9-18 months (generally at the next well child visit).

†1. May be distantly immune, but the test may not be sensitive enough to detect a very low level of anti-HBs in serum

2. May be susceptible with a false positive anti-HBc

3. May be chronically infected and have an undetectable level of HBsAg present in the serum

4. Passive transfer of antibody following HBIG administration or from an HBsAg-positive mother to her newborn

Last reviewed: July 21, 2023

Serologic testing for immunity is not necessary or recommended after routine vaccination of infants, children, or adults. Testing for anti-HBs after vaccination is recommended for the following groups whose subsequent clinical management depends on knowledge of their immune status:

  • Infants born to HBsAg-positive women and infants born to women whose HBsAg status remains unknown (for example, infants surrendered shortly after birth); postvaccination serologic testing should consist of testing for anti-HBs and HBsAg and should not occur before age 9 months
  • Healthcare professionals and public safety workers at risk for blood or body fluid exposure
  • Hemodialysis patients (and other persons who might require outpatient hemodialysis), people living with HIV, and other immunocompromised people (such as hematopoietic stem-cell transplant [HSCT] recipients or people receiving chemotherapy), to determine the need for revaccination and the type of follow-up testing, and
  • Sex partners of HBsAg-positive people, to determine if they have not achieved immunity and will need revaccination and to continue to use other methods of protection against HBV infection.

Testing of individuals other than infants should be performed 1–2 months after administration of the final dose of the vaccine series using a method that allows determination of a protective concentration of anti-HBs (10 mIU/mL or higher). Testing of infants should take place after administration of the final dose of the vaccine series when the infant is age 9 through 12 months. Testing should not be done earlier than 9 months to avoid inadvertent detection of HBIG administered at birth and to maximize the likelihood of detecting HBV infection, if present.

Last reviewed: July 21, 2023

Some isolated positive anti-HBc results are false positives (it is the most common false positive HBV marker). If that can be established, the individual can and likely should be vaccinated, assuming there is an indication or desire to be protected. If the positive anti-HBc is believed to be a true positive, the individual would not require vaccination since they have already (presumably) had HBV infection. Isolated positive anti-HBc could indicate low-level chronic infection. In an infant isolated anti-HBc could indicate passive transfer of antibody from a mother who is HBsAg positive, which is why anti-HBc testing of infants is not recommended.

Additional resources for the evaluation of isolated anti-HBc antibody results are available from the University of Washington: www.hepatitisb.uw.edu/go/screening-diagnosis/diagnosis-hbv/core-concept/all and from CDC: www.cdc.gov/hepatitis/hbv/ interpretationOfHepBSerologicResults.htm.

Last reviewed: July 21, 2023

Reporting of adequate and inadequate is acceptable only if your lab is using mIUs as the measurement for anti-HBs and the cutoff is below 10 mIU for reporting inadequate anti-HBs and 10 mIU or higher for reporting adequate anti-HBs. You should check with your lab to be certain this is being done.

Last reviewed: July 21, 2023

Most likely this person has a resolved HBV infection and is immune. However, it would be preferable to test her again for all these serologic markers, and also quantify the anti-HBs result. If the results are still positive for anti-HBc, and anti-HBs is less than the immune level of 10 mIU/mL, you can give her one dose of HepB vaccine and test again in 1–2 months. If the anti-HBs is positive (10 mIU/mL or higher), she is immune. No further action is needed other than to document the results. If the anti-HBs is still negative, complete the vaccine series and test again 1–2 months after the last dose of vaccine.

Last reviewed: July 21, 2023

For the general public, only one HepB series is routinely recommended in a lifetime, with specific exceptions described below.

As of April 2022, CDC recommends HepB vaccination of the following:

  • Routine HepB vaccination of all infants, beginning with a birth dose.
  • Routine HepB vaccination of all children and adults through age 59 years.
  • Vaccination of all adults age 60 years and older with risk factors for hepatitis B:
    • People at risk for infection by sexual exposure
      • Sex partners of people testing positive for HBsAg
      • Sexually active people who are not in a long-term, mutually monogamous relationship (e.g., those with more than one sex partner during the previous 6 months)
      • People seeking evaluation or treatment for a sexually transmitted infection
      • Men who have sex with men
    • People at risk for infection by percutaneous or mucosal exposure to blood
      • People with current or recent injection drug use
      • Household contacts of people testing positive for HBsAg
      • Residents and staff members of facilities for people with developmental disabilities
      • Health care and public safety personnel with reasonably anticipated risk for exposure to blood or blood-contaminated body fluids
      • People on maintenance dialysis, including in-center or home hemodialysis and peritoneal dialysis, and people who are predialysis
      • People with diabetes, at the discretion of the treating clinician
    • Others
      • International travelers to countries with high or intermediate levels of endemic HBV infection (HBsAg prevalence of 2% or higher)
      • People with hepatitis C virus infection
      • People with chronic liver disease (including, but not limited to, people with cirrhosis, fatty liver disease, alcoholic liver disease, autoimmune hepatitis, and an alanine aminotransferase or aspartate aminotransferase level greater than twice the upper limit of normal)
      • People with HIV infection
      • People who are incarcerated
  • Adults age 60 or older years without known risk factors for hepatitis B infection may receive HepB.

People with documentation of complete vaccination or documentation of previous HBV infection generally do not need to be vaccinated; however, there is no evidence that administration of additional doses of HepB to someone who is already immune or infected is harmful. Serologic testing is not required before vaccination and should not pose a barrier to access to vaccination. If testing is done, it may be done at the same visit when the first dose of vaccine is administered.

Revaccination is recommended only for individuals for whom post-vaccination serologic testing (PVST) is recommended and evidence of nonresponse is found. Annual serologic testing of people undergoing dialysis is recommended, with booster doses administered when detectable antibodies drop below 10 mIU/mL. Annual testing and revaccination may be indicated for other immunocompromised people. See CDC 2018 ACIP recommendations for a detailed discussion of these issues: www.cdc.gov/mmwr/volumes/67/rr/pdfs/rr6701-H.pdf (pages 21-24).

Last reviewed: July 21, 2023

All current and recent past ACIP recommendations concerning hepatitis B vaccination are available at: www.cdc.gov/vaccines/hcp/acip-recs/vacc-specific/hepb.html.

The most recent recommendations for adult HepB vaccination were published in MMWR on April 1, 2022. This publication details the routine catch-up recommendation for HepB vaccination of all adults age 19 through 59 years. The document is available at www.cdc.gov/mmwr/volumes/71/wr/pdfs/mm7113a1-H.pdf.

The 2018 comprehensive ACIP HepB recommendations publication contains detailed guidance on pediatric vaccination, post-vaccination serologic testing of healthcare professionals and other select high risk individuals, as well as the prevention of mother-to-child transmission of hepatitis B. It is available at www.cdc.gov/mmwr/volumes/67/rr/pdfs/rr6701-H.pdf.

In addition to the published recommendations, CDC has produced a frequently asked questions page for HBV infection and HepB vaccination: www.cdc.gov/hepatitis/hbv/hbvfaq.htm.

Last reviewed: August 19, 2023

Four hepatitis B (HepB) vaccines are currently licensed in the United States. Three of them contain recombinant hepatitis B surface antigen (HBsAg) produced in yeast cells. PreHevbrio (VBI), is a 3-antigen recombinant hepatitis B vaccine that is derived from mammalian (Chinese hamster ovary) cells.

HepB vaccines are available as HepB-only formulations; two of them are also available in combination with other vaccines. Heplisav-B (Dynavax) and PreHevbrio are both approved only for people 18 years of age and older. Engerix-B (GSK) and Recombivax HB (Merck) are approved for vaccination starting at birth and are available in both pediatric and adult formulations. For the 3-dose series of Engerix-B or Recombivax HB, people 0 through 19 years of age receive a 0.5 mL dose regardless of their height or weight; people 20 years of age and older receive a 1.0 mL dose.

Three combination vaccines that contain HepB are available in the United States. Pediarix (GSK) is approved for children 6 weeks through 6 years of age and contains HepB, DTaP, and inactivated poliovirus (IPV). Twinrix (GSK) is approved for adults 18 years of age and older and contains HepB and inactivated hepatitis A virus (HepA). Vaxelis (MCM Company) is approved for use in children 6 weeks through 4 years of age and contains HepB, DTaP, Hib, and IPV.

Last reviewed: July 21, 2023

No. It is the volume of the dose, not the antigen content, that is important. People 20 years and older should always receive a 1.0 mL dose of either Engerix-B or Recombivax HB when using those products. Likewise, people younger than 20 years should always receive a 0.5 mL dose of the pediatric formulation of either Engerix-B or Recombivax HB.

Last reviewed: July 21, 2023

Heplisav-B (Dynavax) was approved by the Food and Drug Administration (FDA) in November 2017 for people 18 years of age and older. Heplisav-B contains a novel adjuvant (CpG 1018) that binds to Toll-like receptor 9 to stimulate the immune response to HBsAg. It is provided in a single dose 0.5 mL vial and given as a 2-dose series with doses separated by 1 month (4 weeks).

Heplisav-B was approved based on clinical trials that compared seroprotection rates (SPR, defined as anti-HBs of 10 mIU or higher, and indicative of protection against hepatitis B infection) following 2 doses of Heplisav-B to rates following 3 doses of Engerix-B (GSK). Among people 18 through 70 years of age, SPRs were 90%–95% following 2 doses of Heplisav-B and 65%–81% following 3 doses of Engerix-B. Local reactions were most commonly reported (injection site pain, redness, and swelling) and were similar in frequency to those following Engerix-B.

The package insert for Heplisav-B is available here: www.fda.gov/media/108745/download.

Last reviewed: July 21, 2023

PreHevbrio (VBI) was approved by the FDA in November 2021 for people age 18 years and older. It is a triple-antigen (containing S, Pre-S1, and Pre-S2 HBV surface proteins) recombinant vaccine produced in mammalian cells (Chinese hamster ovary cells), and containing an alum adjuvant. It is given intramuscularly in a 3-dose series of 1.0 mL (10 mcg) doses administered on a 0-, 1-, and 6-month schedule. The most common side effects of vaccination are injection site pain and tenderness, as well as fatigue, muscle aches, and headache.

PreHevbrio was approved based on clinical trials conducted in adults age 18 years and older that compared seroprotection rates (SPR, defined as anti-HBs of 10 mIU or higher, and indicative of protection against HBV infection) following 3 doses of PreHevbrio to rates following 3 doses of Engerix-B (GSK). The SPR for PreHevbrio among adults age 18 years or older ranged from 83.6% to 99.2% (overall, 91.2% for all adults) compared to Engerix-B, which ranged from 64.7% to 91.1% (overall, 76.5% for all adults).

PreHevbrio was included as an option for HepB vaccination of adults age 18 years or older in the current ACIP recommendations published on April 1, 2022: www.cdc.gov/mmwr/volumes/71/wr/pdfs/mm7113a1-H.pdf.

The package insert for PreHevbrio is available here: www.fda.gov/media/154561/download.

Last reviewed: July 21, 2023

The schedule for HepB vaccination depends on the brand in use. Heplisav-B is administered intramuscularly on a 2-dose schedule with doses separated by 1 month (4 weeks). Routine primary vaccination with PreHevbrio, Engerix-B, Recombivax HB, or Twinrix consists of three intramuscular doses administered on a 0-, 1-, and 6-month schedule.

Alternative vaccination schedules for Engerix-B and Recombivax HB (for example, 0, 1, and 4 months or 0, 2, and 4 months) have been demonstrated to elicit dose-specific and final rates of seroprotection similar to those obtained on a 0-, 1-, and 6-month schedule. Increasing the interval between the first 2 doses has little effect on immunogenicity or the final antibody concentration. The third dose confers the maximum level of seroprotection and provides long-term protection.

Recombivax HB may be administered in a 2-dose schedule at 0 and 4–6 months for adolescents age 11 through 15 years using the adult formulation (1.0 mL). Pediarix (GSK) and Vaxelis (MCM) combination vaccines are administered at age 2, 4, and 6 months; they are not used for the birth dose. Twinrix may be administered on an accelerated 4-dose schedule at 0, 7, and 21–30 days, followed by a dose at 12 months.

HepB vaccination of adult (age 20 years and older) hemodialysis patients consists of high-dose (40 µg) Recombivax HB administered on a 0-, 1-, and 6-month schedule or high-dose (2 mL) Engerix-B administered on a 0-, 1-, 2-, and 6-month schedule. Heplisav-B and PreHevbrio have not been studied in patients on hemodialysis.

Last reviewed: July 21, 2023

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