Ask the Experts: Hepatitis B: Vaccine Recommendations

Results (16)

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

For all ages, when the HepB schedule is interrupted, the vaccine series does not need to be restarted. If the Heplisav-B series is interrupted, the second (final) dose should be given as soon as possible. For Engerix-B, Recombivax HB, and PreHevbrio, if the series is interrupted after the first dose, the second dose should be administered as soon as possible, and the second and third doses should be separated by at least 8 weeks. If only the third dose has been delayed, it should be administered as soon as possible.

Last reviewed: July 21, 2023

The minimum interval between the two doses of Heplisav-B is 4 weeks. For the 3-dose series vaccines, Engerix-B, PreHevbrio, and Recombivax HB, the minimum interval between the first and second doses is 4 weeks. The final dose of vaccine must be administered at least 8 weeks after the second dose and should follow the first dose by at least 16 weeks. Vaccine doses administered 4 or fewer days before the minimum interval or age are considered valid. Doses received 5 or more days before the minimum interval or age should be repeated using the correct schedule. Because of the unique accelerated schedule for Twinrix, the 4-day “grace period” does not apply to the first three doses of this vaccine when administered on a 0-, 7-, 21–30-day, and 12-month schedule.

Last reviewed: July 21, 2023

What you do depends on when the error is identified. If the error is discovered while the person is still in the office, you can administer the other “half” of the Engerix-B dose. If the error is discovered later, the dose should not be counted. The person should be recalled to the office and given a full age-appropriate 1.0 mL repeat dose. The same recommendation would apply if the error was with Recombivax HB.

Last reviewed: July 21, 2023

Studies indicate that immunologic memory remains intact for at least 30 years and confers protection against clinical illness and chronic HBV infection, even though anti-HBs levels that once measured adequate might become low or decline below detectable levels. If exposed to HBV, people whose immune systems are competent will mount an anamnestic response and develop protective anti-HBs. Studies are on-going to assess whether booster doses of HepB will be needed in the future.

Last reviewed: July 21, 2023

You should use condoms until a postvaccination blood test (hepatitis B surface antibody, or anti-HBs) shows that your partner is protected from HBV infection. The efficacy of latex condoms in preventing infection with HBV is unknown, but their proper use might reduce the risk of transmission. Your sexual partner should have the 2- or 3-dose series of HepB vaccine (depending on brand) and postvaccination blood testing 1 to 2 months after the last dose of vaccine. If your partner’s test shows adequate anti-HBs (at least 10 mIU/mL), then they should be protected against HBV infection.

Last reviewed: July 21, 2023

In its 2006 ACIP recommendation for the prevention of hepatitis B, an accelerated 4-dose series of hepatitis B vaccine (which was not FDA-approved) was described as acceptable. CDC experts no longer recommend that approach when travel is imminent because other FDA-approved options exist.

The simplest option is Heplisav-B: its 2-dose series may be completed in 4 weeks. If Heplisav-B is unavailable, another option is to give the first 3 doses of the 4-dose accelerated schedule for Twinrix (HepA-HepB) at 0 days, 7 days, and 21-30 days and to have her return for a fourth dose 12 months after dose 1. Although this patient does not need the hepatitis A component, a combination vaccine such as Twinrix may be used if a single antigen option is not feasible; the additional doses of hepatitis A vaccine are not harmful.

Last reviewed: July 21, 2023

It is not necessary to restart or add doses to the HepB series (or any other routine vaccine series) because of a prolonged interval between doses. Just continue the series from the point where it was interrupted. Note that the 2-dose Recombivax HB series using the adult formulation is approved only for adolescents 11 through 15 years of age. At age 16 years, the schedule reverts to the standard pediatric formulation 3-dose schedule rather than 2 adult doses.

Last reviewed: July 21, 2023

Yes. You should draw the blood first and then administer the first dose of vaccine, as transient HBsAg-positivity has been detected after a dose of HepB (see related question).

Last reviewed: July 21, 2023

It is advisable to wait at least 4 weeks. Published studies have found that transient HBsAg-positivity can be detected for up to 18 days after HepB vaccination (up to 52 days among hemodialysis patients). This does not mean the person is infected with HBV. However, donating too close to receipt of HepB could cause a person to be permanently deferred from blood donation if that person tests transiently HBsAg positive after the vaccine dose.

Last reviewed: July 21, 2023

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