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Hepatitis B

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Hepatitis B

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Disease Issues
What are the signs and symptoms of hepatitis B?
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. In 2015, an estimated 21,900 new HBV infections occurred. A total of 1,714 hepatitis B-related deaths were reported, with the highest fatality rates in adults age 55 through 64 years of age. 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.
How long does it take to show signs of illness after a person becomes infected with HBV?
If signs or symptoms of illness occur, they begin an average of 90 days (range: 60–150 days) after exposure to HBV.
How is hepatitis B virus (HBV) transmitted?
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). Risk factors for sexual transmission among heterosexuals include having unprotected sex with an infected partner, having unprotected sex with more than one partner, and a history of another sexually transmitted infection (STI).
Risk factors associated with sexual transmission among MSM include having multiple sex partners, history of another STI, and anal intercourse. 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.
More of my patients are getting tattoos and body piercings. Should they be concerned about contracting a bloodborne infection like HBV?
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.
What is the risk for transmitting HBV by oral sex?
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.
If a patient is diagnosed with acute hepatitis B and then resolves the infection, can the patient ever get hepatitis B again?
Generally speaking, no. It is possible, however, for a person to have two different HBV infections, the second due to an HBV variant or a different HBV subtype. This is not a common occurrence.
How stable is HBV in the environment? What types of equipment cleaners are effective against HBV?
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.
Tests and Interpretation Back to top
What are the various serologic tests for hepatitis B?
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.
How do I interpret some of the common hepatitis B panel results?

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 no vaccination necessary
HBsAg
anti-HBc
anti-HBs
negative
positive
positive
immune due to natural 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 after hepatitis B immune globulin administration
Who should be tested for anti-HBs after vaccination?
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
  • Healthcare professionals and public safety workers at risk for blood or body fluid exposure
  • Hemodialysis patients (and other persons who might require outpatient hemodialysis), HIV-infected persons, and other immunocompromised persons (such as hematopoietic stem-cell transplant recipients or persons receiving chemotherapy), to determine the need for revaccination and the type of follow-up testing, and
  • Sex partners of HBsAg-positive persons, 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 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).
I have a patient who is positive for anti-HBc (hepatitis B core antibody) but negative for all other hepatitis B serologic markers. Should he receive hepatitis B vaccine?
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. People found to be anti-HBc positive should be tested for HBsAg. HBsAg testing may be performed on the same specimen collected for anti-HBc testing. If the HBsAg test result is positive, the person is infected and should receive appropriate management.
I work in a dialysis unit. Our lab reports anti-HBs results as adequate or inadequate, rather than providing a quantitative result. Is this acceptable?
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.
We did a hepatitis B panel for a new hospital employee from Gambia. She had no documentation of having been vaccinated. Her results showed HBsAg nonreactive, anti-HBc reactive, IgM anti-HBc nonreactive, and anti-HBs borderline. We don’t know how to interpret these results. Should she be immunized?
Most likely this person has a resolved hepatitis B 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 hepatitis B 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.
Vaccine Recommendations Back to top
Where can I locate CDC's recommendations for hepatitis B vaccination?
The most recent comprehensive recommendations for hepatitis B vaccination were published in January 2018. The document is available at www.cdc.gov/mmwr/volumes/67/rr/pdfs/rr6701-H.PDF. Recommendations for the use of adjuvanted hepatitis B vaccine (Heplisav-B, Dynavax) were published in April 2018 and are available at www.cdc.gov/mmwr/volumes/67/wr/pdfs/mm6715a5-H.pdf.
Please describe the currently available hepatitis B vaccines.
All hepatitis B (HepB) vaccines currently available in the United States contain recombinant hepatitis B surface antigen (HBsAg) produced in yeast cells. Hepatitis B vaccines are available as a single-antigen formulation and in combination with other vaccines. Of the three single antigen vaccines available in the United States, Engerix-B (GlaxoSmithKline) and Recombivax HB (Merck) are approved for vaccination starting at birth. Heplisav-B (Dynavax) is approved only for persons 18 years of age and older.
Engerix-B and Recombivax HB are available in both pediatric and adult formulations. For the 3-dose series of both vaccines, persons 0 through 19 years of age receive a 0.5 mL dose regardless of their height or weight. Persons 20 years of age and older receive a 1.0 mL dose.
Two combination vaccines that contain hepatitis B are available. Pediarix (GlaxoSmithKline) is approved for children 6 weeks through 6 years of age and contains HepB, DTaP, and inactivated poliovirus. Twinrix (GlaxoSmithKline) is approved for persons 18 years of age and older and contains HepB and inactivated hepatitis A virus. Comvax (Merck), a combination vaccine that contained HepB and Haemophilus influenzae type b is no longer available in the United States.
The adult formulation of Engerix-B contains twice as much antigen per dose as the adult formulations of Recombivax HB. If a patient received 10 mcg (1 mL) of Recombivax for the first dose, and I stock only Engerix, should I give a 10 mcg (0.5 mL) dose of Engerix for subsequent doses?
No. It is the volume of the dose, not the antigen content, that is important. Persons 20 years and older should always receive a 1.0 mL dose of either Engerix-B or Recombivax HB. Likewise, persons younger than 20 years should always receive a 0.5 mL dose of the pediatric formulation of either Engerix-B or Recombivax HB.
Please provide information about Heplisav-B.
Heplisav-B was approved by the Food and Drug Administration in November 2017 for persons 18 years of age and older. Heplisav-B contains a novel immunostimulatory adjuvant (CpG 1018) that binds to Toll-like receptor 9 to stimulate a directed 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.
Heplisav-B was approved based on clinical trials that compared seroprotection rates (SPR, defined as anti-HBs of 10 mIU or higher) following 2 doses of Heplisav-B to rates following 3 doses of Engerix-B (GlaxoSmithKline). Among persons 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.
What is the schedule for hepatitis B vaccine?
Primary vaccination with Engerix-B, Recombivax HB, or Twinrix consists of three intramuscular doses administered on a 0-, 1-, and 6-month schedule. Heplisav-B is administered intramuscularly on a 2-dose schedule with doses separated by 1 month.
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 11 through 15 years of age using the adult formulation (1.0 mL). Pediarix is administered at ages 2, 4, and 6 months; it is not used for the birth dose. Twinrix may be administered on an accelerated schedule at 0, 7, and 21–30 days, followed by a dose at 12 months.
Hepatitis B vaccination of adult (20 years old 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. The Heplisav-B schedule for hemodialysis patients is two 0.5 mL doses, separated by 1 month.
If the vaccination series is interrupted does the series need to be restarted?
For all ages, when the hepatitis B vaccine schedule is interrupted, the vaccine series does not need to be restarted. For Engerix-B and Recombivax HB, 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. If the Heplisav-B series is interrupted, the second (final) dose should be given as soon as possible.
What are the minimum intervals between doses in the hepatitis B vaccine series?
For Engerix-B 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. The minimum interval between doses of Heplisav-B is 4 weeks.
We inadvertently gave a 25-year-old a pediatric (0.5 mL) dose of Engerix-B. Can we just give her another pediatric dose or should she receive a repeat adult dose?
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.
Can Heplisav-B be used to complete a vaccination series started with Engerix-B or Recombivax HB?
Yes. However, data are limited on the safety and immunogenicity effects when Heplisav-B is interchanged with hepatitis B vaccines from other manufacturers. When feasible, the same manufacturer’s vaccines should be used to complete the series. However, vaccination should not be deferred when the manufacturer of the previously administered vaccine is unknown or when the vaccine from the same manufacturer is unavailable.
The 2-dose hepatitis B vaccine series for adults only applies when both doses in the series consist of Heplisav-B. Series consisting of a combination of 1 dose of Heplisav-B and a vaccine from a different manufacturer should consist of 3 total vaccine doses and should adhere to the 3-dose schedule minimum intervals of 4 weeks between dose 1 and 2, 8 weeks between dose 2 and 3, and 16 weeks between dose 1 and 3. Doses administered at less than the minimum interval should be repeated. However, a series containing 2 doses of Heplisav-B administered at least 4 weeks apart is valid, even if the patient received a single earlier dose from another manufacturer.
How long is hepatitis B vaccine protective?
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 hepatitis B vaccine will be needed in the future.
I tested positive for chronic HBV infection about 5 months ago. I know there is a vaccine to prevent transmission, however, I would like to know how long my sex partner should wait after taking this vaccine, before having sex with me without any risk of transmission?
You should use condoms until a postvaccination blood test (hepatitis B surface antibody, or anti-HBs) shows that your sex 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 hepatitis B vaccine (depending on brand) and postvaccination blood testing 1 to 2 months after the last dose of vaccine. If your sex partner's test shows adequate anti-HBs (at least 10 mIU/mL), then he/she should be protected against HBV infection.
Where can I find out about vaccine shortages?
For detailed information about hepatitis B vaccine and other vaccine shortages, go to CDC's website at www.cdc.gov/vaccines/vac-gen/shortages.
My adult patient is traveling to Nigeria in three days. She is already immune to hepatitis A, but we want to provide protection for hepatitis B. She received Twinrix two weeks ago and then a dose of single-component hepatitis B vaccine one week ago. How can we best provide protection in this circumstance?
Even though ACIP does not recommend an accelerated hepatitis B vaccine schedule in routine circumstances, a 4-dose series at 0, 7, 14 days, and 6 months is acceptable (see https://www.cdc.gov/mmwr/PDF/rr/rr5516.pdf, page 27). Although this schedule deviates from the routine recommendation it can be used if travel is imminent. Give a dose of hepatitis B vaccine now which will complete 3 of the 4-dose accelerated schedule. She will need a fourth and final dose 6 months after the first dose in the accelerated schedule.
An adolescent received the first dose of hepatitis B vaccine at age 11 years but did not return for subsequent doses. If the patient comes back at age 16 years, is it necessary to repeat the first dose of the series?
It is not necessary to restart or add doses to the hepatitis B 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.
If you want to test and vaccinate your patient for hepatitis B on the same day, does it matter if you test or vaccinate first?
Yes. You should draw the blood first and then administer the first dose of vaccine, as transient HBsAg-positivity has been found to occur after a dose of hepatitis B vaccine (see next question).
How long should a person wait to donate blood or have an HBsAg blood test after a dose of hepatitis B vaccine?
It is advisable to wait at least 3 weeks. Studies published in the last several years have found that transient HBsAg-positivity can be detected for up to 18 days after 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 hepatitis B vaccine could cause a person to be permanently deferred from blood donation if that person tests transiently HBsAg positive after the vaccine dose.
Pregnancy, Perinatal, and Infants Back to top
Where can I obtain a copy of the most recent recommendation of the Advisory Committee on Immunization Practices (ACIP) for the prevention of perinatal transmission of HBV infection?
The January 2018 recommendations are available at www.cdc.gov/mmwr/volumes/67/rr/pdfs/rr6701-H.PDF.
What is the schedule for hepatitis B vaccine administration for infants who weigh less than 2000 grams?
Decreased seroconversion rates might occur among preterm infants with birth weights less than 2,000 grams after administration of hepatitis B vaccine at birth. However, by the chronological age of 1 month, all preterm infants, regardless of initial birth weight, are likely to respond as adequately as larger infants. Infants who weigh less than 2,000 grams born to HBsAg-positive women and women with unknown HBsAg status (if the mother’s HBsAg status cannot be determined within 12 hours of birth) must receive immunoprophylaxis with hepatitis B vaccine and hepatitis B immune globulin (HBIG) within 12 hours of birth. The initial vaccine dose should not be counted toward completion of the hepatitis B series, and 3 additional doses of hepatitis B vaccine should be administered, beginning when the infant is age 1 month. Infants weighing less than 2,000 grams born to HBsAg-negative mothers should receive the first dose of the hepatitis B series at hospital discharge or at chronological age 1 month (even if weight is still less than 2,000 grams), whichever comes first.
What blood test should be used to screen a pregnant woman to prevent perinatal HBV infection?
Screening should be done with the hepatitis B surface antigen (HBsAg) test only. This blood test will tell whether a woman has current HBV infection that can be transmitted to her infant. Ordering other blood tests such as total antibody to hepatitis B core antigen (total anti-HBc) and/or anti-HBs are not useful when screening to prevent perinatal HBV infections and should not be included in screening pregnant women for perinatal HBV infection. Total anti-HBc will be positive in all HBsAg-positive people and anti-HBs is rarely positive in an HBsAg-positive person. Women who are found to be positive should be tested for HBV DNA to guide the use of maternal antiviral therapy during pregnancy for the prevention of perinatal HPV transmission (see MMWR 2018;67 [RR-1]:13). The woman should also be referred to their jurisdiction’s Perinatal Hepatitis B Prevention Program for case management to ensure that their infants receive timely prophylaxis and follow-up.
Do women who have been vaccinated previously against HBV infection still need to be screened during pregnancy?
Yes. Women who have received hepatitis B vaccine should still be screened for HBsAg early in each pregnancy. Just because a woman has been vaccinated does not mean she is HBsAg negative. Since postvaccination testing is not performed for most vaccinated people, she could have been vaccinated even though she was already HBsAg positive.
I've identified a patient in my obstetrical practice who is HBsAg positive. Should she be evaluated for liver disease during her pregnancy, or should the evaluation wait until the postpartum period? What should I recommend for her husband and her children? How urgent is the time frame?
The earlier the evaluation is done, the better. Consultation with or referral to a liver disease specialist (such as a hepatologist, gastroenterologist, or infectious disease specialist) should be done. The consulting/referral physician should be aware of the patient's obstetrical status. In addition, the patient's sex partner and children or other household contacts should be tested for HBV infection (total anti-HBc and HBsAg) as soon as possible. If any are susceptible to HBV infection (total anti-HBc and HBsAg negative), they should be vaccinated. If any are HBsAg positive, they should be referred to or have consultation with a liver disease specialist.
If a mother's HBsAg test result is not available at the time of birth, how should the infant be managed?
Infants born to women for whom HBsAg testing results during pregnancy are not available but other evidence suggestive of maternal HBV infection exists (for example presence of HBV DNA, HBeAg-positive, or mother known to be chronically infected with HBV) should be managed as if born to an HBsAg-positive mother.
Women admitted for delivery without documentation of HBsAg test results should have blood drawn and tested as soon as possible after admission.
While test results are pending, all infants with birth weights of 2,000 grams or more born to women without documentation of HBsAg test results should receive the first dose of single-antigen hepatitis B vaccine (without HBIG) within 12 hours of birth. Only single antigen hepatitis B vaccine should be used for the birth dose.
If the mother is determined to be HBsAg positive, her infant should receive HBIG as soon as possible but no later than age 7 days, and the vaccine series should be completed according to a recommended schedule for infants born to HBsAg-positive mothers.
If the mother is determined to be HBsAg negative, the vaccine series should be completed according to a recommended schedule for infants born to HBsAg-negative mothers.
For preterm infants, see the next question.
Please review the hepatitis B vaccination recommendations for preterm infants who weigh less than 2,000 grams (4.4 pounds), as well as for those premature infants who weigh more.
Preterm infants weighing less than 2,000 grams (4.4 pounds) at birth have a decreased response to hepatitis B vaccine administered before age 1 month. By age 1 month, medically stable preterm infants, regardless of initial birth weight or gestational age, have an immunologic response to hepatitis B vaccination that is comparable to that of full-term infants. For preterm infants weighing less than 2,000 grams at birth:
If maternal HBsAg status is positive:
    Give hepatitis B immune globulin (HBIG) plus hepatitis B vaccine within 12 hours of birth. The birth dose (the initial hepatitis B vaccine dose) should not be counted as part of the vaccine series.
    Give 3 additional hepatitis B vaccine doses (for a total of 4 doses) at ages 1, 2 to 3, and 6 months, or hepatitis B-containing combination vaccine (Pediarix) at ages 2, 4, and 6 months. The final dose should not be administered before 24 weeks of age.
    Test for HBsAg and anti-HBs at age 9–12 months, or 1–2 months after the final dose of the vaccine series if completion of the series is delayed. Testing should not be performed before age 9 months (anti-HBs resulting from use of HBIG might still be positive and therefore misleading) or within 1 month of the most recent vaccine dose (testing for HBsAg sooner than 1 month of a vaccine dose might produce a transient HBsAg-positivity).
If maternal HBsAg status is unknown:
  If the mother’s HBsAg status cannot be determined within 12 hours of birth give HBIG plus hepatitis B vaccine. The birth dose of vaccine should not be counted as part of the 3 doses required to complete the vaccine series.
  Three additional doses of vaccine (for a total of 4 doses) should be administered according to the recommended schedule on the basis of the mother’s HBsAg test result. The final dose in the series should not be administered before 24 weeks of age.
If it is not possible to determine the mother’s HBsAg status:
  The vaccine series should be completed according to a recommended schedule for infants born to HBsAg positive mothers.
If the maternal HBsAg status is negative:
  If you are certain that appropriate maternal testing was done and a copy of the mother's original laboratory report indicating that she was HBsAg negative during this pregnancy is placed on the infant's chart, delay the first dose of hepatitis B vaccine until age 1 month or hospital discharge (even if weight is still less than 2,000 grams), whichever comes first. Complete the vaccine series per the recommended schedule.
For preterm infants weighing 2,000 grams or more at birth, follow the recommendations for full-term infants including a dose within 24 hours of birth.
What is the recommended time to do hepatitis B testing for evidence of success or failure of immunoprophylaxis given at birth to an infant born to a hepatitis B surface antigen (HBsAg)-positive mother?
In 2015, CDC revised the recommendation for the timing of hepatitis B serologic testing for infants born to an HBsAg-positive woman. Postvaccination testing (HBsAg and hepatitis B surface antibody [anti-HBs]) is now recommended 1 to 2 months after completion of at least three doses of the hepatitis B vaccine series. For a child on schedule, this is age 9 to 12 months. Testing should not be performed before age 9 months, as hepatitis B immune globulin (HBIG) might still be present for 6 to 8 months, nor should testing be performed within 1 month of the most recent hepatitis B vaccine dose because a transient false positive HBsAg might occur. Antibody to hepatitis B core (anti-HBc) testing of infants or children is not recommended because passively acquired maternal anti-HBc might be detected up to age 24 months in children of HBV-infected mothers. Children who are HBsAg positive should receive medical evaluation and ongoing follow-up. For additional information, see www.cdc.gov/mmwr/pdf/wk/mm6439.pdf, pages 1118–20.
How should I manage an infant of an HBsAg-positive mother who tests negative for anti-HBs after 3 properly spaced doses of vaccine?
HBsAg-negative infants with anti-HBs levels 10 mIU/mL or higher are protected and need no further medical management. HBsAg-negative infants with anti-HBs less than 10 mIU/mL should be revaccinated with a single dose of hepatitis B vaccine and receive postvaccination serologic testing 1–2 months later. Infants whose anti-HBs remains less than 10 mIU/mL following single dose revaccination should receive 2 additional doses of hepatitis B vaccine to complete the second series, followed by postvaccination serologic testing 1–2 months after the final dose.
Based on clinical circumstances or family preference, HBsAg-negative infants with anti-HBs less than 10 mIU/mL may instead be revaccinated with a second, complete 3-dose series, followed by postvaccination serologic testing performed 1–2 months after the final dose of vaccine.
What should I do if an infant tests negative for anti-HBs after 2 complete vaccine series?
Available data do not suggest a benefit from administering additional hepatitis B vaccine doses to infants who have not attained anti-HBs of mIU/mL or higher following receipt of two complete hepatitis B vaccine series. HBsAg-positive infants should be referred for appropriate follow-up with a physician who specializes in evaluating infants with liver disease.
Is it safe for an HBsAg-positive mother to breastfeed her infant?
Yes. An HBsAg-positive mother who wishes to breastfeed should be encouraged to do so, including immediately following delivery. However, the infant should receive HBIG and hepatitis B vaccine within 12 hours of birth. Although HBsAg can be detected in breast milk, studies done before hepatitis B vaccine was available showed that breastfed infants born to HBsAg-positive mothers did not demonstrate an increased rate of perinatal or early childhood HBV infection. More recent studies have shown that, among infants receiving post-exposure prophylaxis to prevent perinatal HBV infection, there is no increased risk of infection among breastfed infants.
Can Pediarix be given at birth?
No. Pediarix should not be given before age 6 weeks of age because it can result in suppression of the immune response to the acellular pertussis component.
If I want to use Pediarix is it acceptable to give a 4-dose schedule of hepatitis B vaccine to infants?
Yes. The use of a 4-dose hepatitis B vaccine schedule is acceptable when giving the monovalent hepatitis B vaccine birth dose followed by the use of Pediarix. The use of a 4-dose hepatitis B vaccine schedule, including schedules with a birth dose, has not increased vaccine reactogenicity and results in higher final antibody titers that should correlate with longer duration of detectable antibody. The federal Vaccines for Children (VFC) program provides up to four doses of hepatitis B vaccine for VFC-eligible children. You may still use monovalent hepatitis B vaccine in a 3-dose series.
We give hepatitis B vaccine to newborns in the hospital followed by Pediarix at 2, 4, and 6 months of age, so our patients get 4 doses of hepatitis B vaccine. For some children, the Pediarix dose #3 is delayed and given closer to 5 months of age, so the interval is less than 8 weeks between dose #3 and #4 of the hepatitis B component of Pediarix. We are receiving conflicting information about whether their hepatitis B vaccine dose #4 is a valid final dose because of the shortened interval between dose #3 and #4. Our electronic health record says dose #4 is valid (regardless of the short interval from dose #3) but the health department says it is not. Which is correct?
According to subject matter experts at CDC, your electronic health record is correct. The CDC website states that hepatitis B vaccine dose #4, if given, must be at 24 weeks of age or later, and at least 16 weeks from dose #1. There is no minimum interval requirement between dose #4 and the previous dose. This information is not published in any current ACIP statement but it can be found under "Hepatitis B" at www.cdc.gov/vaccines/programs/cocasa/reports/algorithm-ref.html.
An infant was given monovalent hepatitis B vaccine at birth. Later we gave her monovalent hepatitis B vaccine at age 1 month and age 4 months. Did we give her the third dose too early?
Yes. Poorer immune response rates are seen in infants who complete the vaccination series prior to age 6 months. Do not count dose #3, which you gave at age 4 months. Repeat dose #3 when the infant is at least 6 months of age (no earlier than age 24 weeks).
If an infant got a dose of the adult formulation of hepatitis B vaccine in error, should the dose be counted? When should the next dose be scheduled for this infant? Do we need to be concerned about a possible adverse event?
If an infant received an adult dose of hepatitis B vaccine (contains twice the antigen in a dose of the infant/child/adolescent formulation), the dose can be counted as valid and does not need to be repeated. Hepatitis B vaccine is a very safe vaccine and no unusual adverse events would be expected because of this administration error. The next (age appropriate) dose should be given on the usual schedule.
The recommended age for the last dose of hepatitis B vaccine in an infant is 6 months. What is the earliest age the last dose can be given to an infant?
The minimum age for the last dose of hepatitis B vaccine is age 24 weeks (the minimum age is the youngest age that is acceptable for giving a vaccine and having it "count" as a valid dose.) This allows healthcare providers more flexibility in administering hepatitis B vaccine should a parent bring an infant in for a well-baby check before the infant reaches a full 6 months of age. If the third dose is given prior age 24 weeks the dose should not be counted. Poorer response rates are seen in infants who complete the vaccination series prior to age 24 weeks. The third dose should be repeated when the infant is at least age 24 weeks.
For Children and Teens Back to top
Should all children age 0 through 18 years be vaccinated against hepatitis B?
Yes. CDC recommends that all children age 0 through 18 years be fully vaccinated with hepatitis B vaccine. This recommendation is also endorsed by AAP and AAFP and is published as part of the annual Recommended Childhood and Adolescent Immunization Schedule (www.cdc.gov/vaccines/schedules/hcp/child-adolescent.html). Vaccination should be initiated for children and teenagers not previously vaccinated and vaccination completed for all those whose vaccine series is incomplete.
All children and adolescents younger than age 19 years (including internationally adopted children) who were born in Asia, the Pacific Islands, Africa, or other intermediate or high-endemic countries or who have at least one parent who was born in a high-endemic area should be tested for HBsAg and should complete the vaccine series if they were not previously vaccinated or were incompletely vaccinated.
Can adolescents be immunized on a 0-, 2-, 4-month schedule for hepatitis B?
Yes. There are data that show adequate seroprotection using this schedule in young adults. If this schedule is used, you should be aware that the studies were in young adults and might not translate to older adults (age 40 years or older). There are other schedules that offer flexibility in vaccination as well. View www.immunize.org/catg.d/p2081.pdf for a review of different schedules.
Three years ago at a middle school, my patient received the first dose of the hepatitis B vaccine series. Should I give her the second dose now or do I need to start over again with the first dose?
There is no need to restart the series. Give the second dose now and be sure there are at least 8 weeks between that dose and the third dose. Increasing the interval between the first two doses has little effect on immunogenicity or final antibody concentration. The third dose confers the maximum level of seroprotection but acts primarily as a booster and appears to provide optimal long-term protection. Longer intervals between the last two doses result in higher final antibody levels but might increase the risk for acquisition of HBV infection among people who have a delayed response to vaccination. No differences in immunogenicity have been observed when one or two doses of hepatitis B vaccine produced by one manufacturer are followed by doses from a different manufacturer.
Describe the 2-dose regimen for hepatitis B vaccine for certain adolescents.
For the 2-dose schedule, the adult dose of Recombivax HB (1.0 mL dose) is administered to adolescents age 11 through 15 years, with the second dose given 4 to 6 months after the first dose. In immunogenicity studies, antibody concentrations and end seroprotection rates (at least 10 mIU/mL of anti-HBs) were similar with the 2-dose schedule and the 3-dose schedule (0.5 mL dose). As with other hepatitis B vaccination schedules, if administration of the 2-dose schedule is interrupted, it is not necessary to restart the series. Children and adolescents who have begun vaccination with a pediatric (0.5 mL) dose of Recombivax HB should complete the 3-dose series with this dose. If it is not clear which dose an adolescent was administered at the start of a series, the series should be completed with the 3-dose schedule.
How should we complete the series if a 12-year-old starts the 2-dose Recombivax HB adult formulation series but fails to receive dose 2 before his or her 16th birthday?
The 2-dose Recombivax HB schedule is only approved for use in children age 11 through 15 years. A 16-year-old child would need two additional doses of pediatric hepatitis B vaccine to complete a 3-dose series.
I am confused about the volume of hepatitis B vaccine dose to give an adolescent. Is it 0.5 mL or 1.0 mL?
The dosage depends on the schedule and manufacturer of the vaccine that you are using. For children 11 through 15 years of age, the 2-dose Recombivax HB volume is 1.0 mL. Otherwise the 3-dose schedule of Recombivax HB or Engerix B is 0.5 mL through age 19 years. . IAC offers a handy resource with charts detailing the correct dosages and schedules for monovalent hepatitis B and hepatitis A vaccines and combination products that include hepatitis A and hepatitis B vaccines. Go to www.immunize.org/catg.d/p2081.pdf.
I have some Asian and African children and teens in my practice who were born abroad. Should I test them all for hepatitis B, or just make sure they are all vaccinated?
All foreign-born people (including immigrants, refugees, asylum seekers, and internationally adopted children) born in Asia, the Pacific Islands, Africa, and other regions with high or intermediate endemicity of HBV infection should be tested for HBsAg, regardless of vaccination status. Initiating vaccination of immigrant children should not be delayed while awaiting hepatitis B test results. All people found to be HBsAg positive should have ongoing medical management by a physician knowledgeable about hepatitis B and its complications.
For Adults Back to top
Which hepatitis B vaccines can be given to adult patients?
Twinrix (combination HepA-HepB, 3-dose series) and Heplisav-B (2-dose series) are approved for adults age 18 years and older. Engerix-B and Recombivax HB (as a 1.0 mL 3-dose series) are approved for adults age 20 years and older.
Which adults should receive hepatitis B vaccine?
The following groups are recommended for hepatitis B vaccination:
Sex partners of HBsAg-positive people
Sexually active people who are not in long-term, mutually monogamous relationships
People seeking evaluation or treatment for a sexually-transmitted infection Men who have sex with men
Current or recent injection drug users
Household contacts of HBsAg-positive people
Residents and staff of facilities for developmentally disabled people
Healthcare and public safety workers with reasonably anticipated risk for exposure to blood or blood-contaminated body fluids
People with end-stage renal disease, including predialysis, hemo-, peritoneal-, and home-dialysis patients
International travelers to regions with intermediate or high levels of HBV infection; visit wwwnc.cdc.gov/travel/yellowbook/2018/infectious-diseases-related-to-travel/hepatitis-b for countries with intermediate or high levels of HBV infection
People with chronic liver disease, including, but not limited to, persons with cirrhosis, fatty liver disease, alcoholic liver disease, autoimmune hepatitis, and an alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level greater than twice the upper limit of normal
People with hepatitis C virus infection
People with HIV infection
Unvaccinated adults with diabetes mellitus from 19 through 59 years of age
Unvaccinated adults with diabetes mellitus who are age 60 or older at the clinician's discretion
Incarcerated persons
All other people who wish to be protected from HBV infection
Acknowledgement of a specific risk factor is NOT a requirement for vaccination. The official CDC recommendations for hepatitis B vaccination of are available at www.cdc.gov/mmwr/volumes/67/rr/pdfs/rr6701-H.pdf.
 
Please provide details about the ACIP recommendation for the use of hepatitis B vaccine in adult diabetic patients.
In 2011, CDC published ACIP recommendations that hepatitis B vaccine be given to adults with diabetes. The vaccine series is recommended for unvaccinated adults with diabetes age 59 years and younger. At the discretion of the treating clinician, the vaccine may also be administered to unvaccinated adults with diabetes age 60 years and older. The recommendations were prompted by a number of outbreaks of hepatitis B virus infection in settings that provide assisted blood glucose monitoring for people with diabetes.
Administration of the hepatitis B vaccine series should be completed as soon as feasible after diabetes is diagnosed. No serologic testing or additional hepatitis B vaccination is recommended for adults who received a complete series of hepatitis B vaccinations at any time in the past.
Hepatitis B vaccine may be administered during healthcare visits scheduled for other purposes, as long as minimum intervals between doses are observed. No maximum interval between doses exists that would make the hepatitis B vaccination series ineffective or that would require restarting the series. You can read the details of this recommendation and the rationale behind it in the December 23, 2011 issue of MMWR, available at www.cdc.gov/mmwr/preview/mmwrhtml/mm6050a4.htm?s_cid=mm6050a4_w.
Does the recommendation to administer hepatitis B vaccine to diabetics younger than age 60 extend to women with gestational diabetes?
No. The 2011 CDC recommendations for hepatitis B vaccination of people with diabetes pertain to those with type-1 and type-2 diabetes. They do not apply to women with gestational diabetes. It is worth noting that pregnancy is not a contraindication to hepatitis B vaccination, and that women with gestational diabetes are more likely to develop type-1 or type-2 diabetes later in life. Diabetic women who become pregnant can be vaccinated, if indicated.
At what anatomic site should hepatitis B vaccine be administered to adults? What needle size should be used?
The deltoid muscle is recommended for routine intramuscular (IM) vaccination among adults. The anterolateral thigh also can be used. The gluteus muscle should not be used as a site for administering hepatitis B vaccine. Please refer to the IAC document Administering Vaccines to Adults: Dose, Route, Site, and Needle Size (available at www.immunize.org/catg.d/p3084.pdf) for complete information on this issue.
 
Is post-vaccination testing needed for adults who receive hepatitis B vaccine?
Serologic testing for immunity after vaccination is recommended only for people whose subsequent clinical management depends on knowledge of their immune status. Testing is not necessary after routine vaccination of adults.
Post-vaccination testing is recommended for the following: healthcare and public safety workers at a reasonable risk of continued exposure to blood on the job; immune compromised people; and sex or needle-sharing partners of HBsAg-positive people. Testing should be performed 1 to 2 months after the last dose of vaccine.
If a person has been sexually assaulted, should he/she be offered HBIG and hepatitis B vaccine?
Sexually transmitted infections, including hepatitis B, can be transmitted by sexual assault. Unless the victim has a documented history of completed hepatitis B vaccination, a series of hepatitis B vaccine alone (2 or 3 doses depending on brand) should be administered with the first dose as soon as possible after the assault. Administration of hepatitis B immune globulin is not necessary.
If a patient receives hepatitis B vaccine while undergoing hemodialysis, will the vaccine be effective? Will the dose need to be repeated?
Neither the Advisory Committee on Immunization Practices (ACIP) nor the manufacturers address the timing of vaccination and dialysis. Persons with end-stage renal disease including predialysis, hemodialysis, peritoneal dialysis, and home dialysis should be tested for hepatitis B surface antibody (anti-HBs) 1–2 months after vaccination, and annually. If the anti-HBs level is below 10mIU/mL, they should be revaccinated.
How often do hemodialysis patients who have received hepatitis B vaccination have to be tested for anti-HBs and HBsAg?
Recommendations for immune compromised people, such as hemodialysis patients, are different than those for immune-competent people. Hemodialysis patients who do not respond to an initial vaccine series should be revaccinated with two to four additional doses of hepatitis B vaccine (depending on the brand).. Hemodialysis patients are considered immune as long as they have adequate anti-HBs (at least 10 mIU/mL). For hemodialysis patients who have responded with adequate anti-HBs (postvaccination testing should be done 1 to 2 months after the vaccine series) to hepatitis B vaccination, no HBsAg testing is needed but anti-HBs should be done annually. If anti-HBs declines below 10 mIU/mL, a booster dose of hepatitis B vaccine should be given and annual anti-HBs testing should be continued. Retesting immediately after the booster dose is not necessary.
What is the maximum number of hepatitis B vaccine doses a dialysis patient can receive?
There is no maximum number of booster doses a dialysis patient can receive. Serology should be performed once a year and a booster dose given if serology is negative (less than 10 mIU/mL). Serology is not recommended more frequently than once a year, so boosters wouldn't be given more than once a year.
A physician ordered a 40-mcg dose of hepatitis B vaccine for a hemodialysis patient. The clinic does not stock the Recombivax HB 40-mcg dose dialysis formulation (Merck) and would like to give 2 doses of Engerix-B 20-mcg dose (GSK) for each dose in the series. Is this acceptable?
Yes. If given on the same day as separate injections in separate sites, two injections of Engerix-B 20 mcg can be counted as the equivalent of one Recombivax HB 40-mcg dose. According to the package insert, Engerix-B is licensed for use in this manner (vaccine package inserts for all vaccines are available at www.immunize.org/fda). Note that an all-Engerix-B or mixed-brand dialysis schedule is a 4-dose series (doses at 0, 1, 2, and 6 months). Vaccination using only Recombivax HB dialysis formulation is a 3-dose schedule (doses at 0, 1, and 6 months).
Some nephrologists give a high dose (40 mcg) of hepatitis B vaccine (2 adult doses of Engerix-B, or Recombivax HB Dialysis Formulation) to all patients with renal failure with glomerular filtration rates (GFRs) of less than 30 ml/min even if the patient is not on dialysis. Is this practice advisable?
A higher dose hepatitis B vaccine is recommended for hemodialysis and other immunocompromised persons, so to the extent these patients are immunocompromised, this is within ACIP recommendations (note that "immunocompromised" is not defined in the recommendations). Regardless, this practice is appropriate for several reasons, including that these patients may be starting hemodialysis soon, and because use of the higher dose is not harmful. This is somewhat of a gray area but the clinician can use his/her clinical judgment.
Can a dialysis or pre-dialysis patient receive Heplisav-B vaccine?
Yes.
I would like more information about Twinrix, the combination hepatitis A and B vaccine.
Twinrix (GlaxoSmithKline) is an inactivated combination vaccine containing both hepatitis A virus (HAV) and HBV antigens. The vaccine contains 720 EL.U. of hepatitis A antigen (half of the Havrix adult dose) and 20 mcg of hepatitis B antigen (the full Engerix-B adult dose). In the United States, Twinrix is licensed for use in people who are age 18 years or older. It can be administered to people who are at risk for both hepatitis A and hepatitis B, such as certain international travelers, men who have sex with men, illegal drug users, or to people who want to be immune to both diseases.
Primary immunization consists of 3 doses given intramuscularly on a 0, 1, and 6 month schedule. In March 2007, the FDA also approved a 4-dose schedule for Twinrix. It consists of 3 doses given within 3 weeks, followed by a booster dose at 12 months (0, 7 days, 21 to 30 days, and 12 months). The 4-dose schedule could benefit individuals needing rapid protection from hepatitis A and hepatitis B, such as people traveling to high-prevalence areas imminently and emergency responders, especially those being deployed to disaster areas overseas. Twinrix cannot be used for post-exposure prophylaxis.
I have seen adults who have had 1 or 2 doses of Twinrix, but we only carry single-antigen vaccine in our practice. How should we complete their vaccination series with single-antigen vaccines?
Twinrix is licensed as a 3-dose series for people age 18 years and older. If Twinrix is not available or if you choose not to use Twinrix to complete the Twinrix series, you should do the following: If 1 dose of Twinrix was given, complete the series with 2 adult doses of hepatitis B vaccine and 2 adult doses of hepatitis A vaccine. If 2 doses of Twinrix were given, complete the schedule with 1 adult dose of hepatitis A vaccine and 1 adult dose of hepatitis B vaccine.
Another way to consider this is as follows:
A dose of Twinrix contains a standard adult dose of hepatitis B vaccine and a pediatric dose of hepatitis A vaccine. So a dose of Twinrix can be substituted for any dose of the hepatitis B series but not for any dose of the hepatitis A series.
Any combination of 3 doses of adult hepatitis B or 3 doses of Twinrix is a complete series of hepatitis B vaccine
One dose of Twinrix and 2 doses of adult hepatitis A is a complete series of hepatitis A vaccine
Two doses of Twinrix and 1 dose of adult hepatitis A is a complete series of hepatitis A vaccine
We're thinking of using Twinrix and we're wondering whether we can use it for doses #1 and #3 only and use single antigen hepatitis B vaccine for dose #2?
No. Twinrix contains 50% less hepatitis A antigen component than Havrix, GSK's monovalent hepatitis A vaccine (720 vs. 1440 El. U.) so the patient would not receive the recommended dose of hepatitis A vaccine antigen. For this reason, 3 doses of Twinrix must comprise the series.
What are the minimum intervals for giving the 3-dose series of Twinrix?
Minimum intervals for Twinrix are 4 weeks between dose #1 and dose #2, and 5 months between dose #2 and dose #3.
For Healthcare Personnel Back to top
Which people who work in healthcare settings need hepatitis B vaccine?
The Occupational Safety and Health Administration (OSHA) requires that hepatitis B vaccine be offered to healthcare personnel (HCP) who have a reasonable expectation of being exposed to blood and body fluids on the job. This requirement does not include personnel who would not be expected to have occupational risk (for example, general office workers). Employers must ensure that workers who decline hepatitis B vaccination sign a declination form. For a fact sheet about this OSHA requirement, go to: www.osha.gov/OshDoc/data_BloodborneFacts/bbfact05.pdf.
At what anatomic site should hepatitis B vaccine be administered to adults? What needle size should be used?
For adults, administer hepatitis B vaccine intramuscularly (IM) in the deltoid muscle. A 22- to 25-gauge, 1–1½ -inch needle should be used. The gluteus muscle should not be used as a site for administering hepatitis B vaccine. For optimal protection, it is crucial that the vaccine be administered IM, not subcutaneously.
Can Heplisav-B be used for vaccinating healthcare professionals?
Yes. Heplisav-B is approved as a 2-dose schedule for persons age 18 years and older, including healthcare professionals. The doses should be separated by at least 4 weeks.
Can Heplisav-B be used to complete a vaccination series started with Engerix-B or Recombivax HB?
Yes. However, data are limited on the safety and immunogenicity effects when Heplisav-B is interchanged with hepatitis B vaccines from other manufacturers. When feasible, the same manufacturer’s vaccines should be used to complete the series. However, vaccination should not be deferred when the manufacturer of the previously administered vaccine is unknown or when the vaccine from the same manufacturer is unavailable.
The 2-dose hepatitis B vaccine series only applies when both doses in the series consist of Heplisav-B. Series consisting of a combination of 1 dose of Heplisav-B and a vaccine from a different manufacturer should consist of 3 total vaccine doses and should adhere to the 3-dose schedule minimum intervals of 4 weeks between dose 1 and 2, 8 weeks between dose 2 and 3, and 16 weeks between dose 1 and 3. Doses administered at less than the minimum interval should be repeated. However, a series containing 2 doses of Heplisav-B administered at least 4 weeks apart is valid, even if the patient received a single earlier dose from another manufacturer.
I work in occupational health and have some patients who are off schedule for their hepatitis B vaccine series. They came back for dose #2 in 4 to 6 months rather than getting it 1 month later. In this situation, what is the correct timing for dose #3? And how long must the interval be between doses before I am required to restart the series?
The minimal intervals for hepatitis B vaccine are at least 4 weeks between doses #1 and #2, at least 8 weeks between doses #2 and #3, and at least 16 weeks between doses #1 and #3. Since in your cases 16 weeks or more have elapsed since dose #1, you should schedule dose #3 to be given 8 weeks after dose #2. It is not necessary to restart the series because of an extended interval between doses, no matter how long.
Is it safe for a healthcare professional to be vaccinated during pregnancy?
Yes. Many years of experience with hepatitis B vaccines indicate no apparent risk for adverse events to a developing fetus. Current hepatitis B vaccines contain noninfectious hepatitis B surface antigen (HBsAg) and should pose no risk to the fetus. If not vaccinated, a pregnant woman may contract an HBV infection during pregnancy, which might result in severe disease for the newborn. Women who breastfeed their babies and are healthcare professionals can and should be vaccinated against hepatitis B if they haven’t been previously vaccinated. Receipt of the vaccine is not a reason to discontinue breastfeeding.
There are no clinical studies of Heplisav-B in pregnant women. Available human data on Heplisav-B administered to pregnant women are insufficient to assess vaccine-associated risks in pregnancy. Until safety data are available for Heplisav-B, providers should continue to vaccinate pregnant women needing hepatitis B vaccination with a vaccine from a different manufacturer.
Which HCP need serologic testing after receiving a hepatitis B vaccine series?
All HCP, including trainees, who have a high risk of occupational percutaneous or mucosal exposure to blood or body fluids (for example, HCP with direct patient contact, HCP at risk of needlestick or sharps injury, laboratory workers who draw, test or handle blood specimens) should have postvaccination testing for antibody to hepatitis B surface antigen (anti-HBs). Postvaccination testing should be done 1–2 months after the last dose of vaccine. Postvaccination testing for persons at low risk for mucosal or percutaneous exposure to blood or body fluids (for example, public safety workers and HCP without direct patient contact) likely is not cost-effective; however, those who do not undergo postvaccination testing should be counseled to seek immediate testing if exposed.
What should be done if a healthcare personnel's postvaccination anti-HBs test is negative (less than 10 mIU/mL) 1–2 months after the last dose of vaccine?
Repeat the 2- or 3-dose series (depending on vaccine brand) and test for anti-HBs 1–2 months after the final dose of the repeat series. Heplisav-B may be used for revaccination following an initial hepatitis B vaccine series that consisted of doses of Heplisav-B or doses from a different manufacturer. Heplisav-B may also be used to revaccinate new healthcare personnel (including the challenge dose) initially vaccinated with a vaccine from a different manufacturer in the distant past who have anti-HBs less than 10 mIU/mL upon hire or matriculation.
If the test is still negative after a second vaccine series, the person should be tested for HBsAg and total anti-HBc to determine their HBV infection status. People who test negative for HBsAg and total anti-HBc should be considered vaccine non-responders and susceptible to HBV infection. They should be counseled about precautions to prevent HBV infection and the need to obtain hepatitis B immune globulin (HBIG) prophylaxis for any known or likely exposure to HBsAg-positive blood. Those found to be HBsAg negative but total anti-HBc positive were infected in the past and require no vaccination or treatment. If the HBsAg and total anti-HBc tests are positive, the person should receive appropriate counseling for preventing transmission to others as well as referral for ongoing care to a specialist experienced in the medical management of chronic HBV infection. They should not be excluded from work.
How often should I test HCP after they've received the hepatitis B vaccine series to make sure they're protected?
For immunocompetent HCP, periodic testing or periodic boosting is not needed. Postvaccination testing (anti-HBs) should be done 1–2 months after the last dose of the hepatitis B vaccine series. If adequate anti-HBs (at least 10 mIU/mL) is present, nothing more needs to be done. This information should be made available to the employee and recorded in the employee's health record. If postvaccination testing is less than 10 mIU/mL, the vaccine series should be repeated and anti-HBs testing done, 1–2 months after the last dose of the second series.
Should a healthcare professional who performs invasive procedures and who once had a positive anti-HBs result be revaccinated if the anti-HBs titer is rechecked and is less than 10 mIU/mL?
No. Immunocompetent people known to have responded to hepatitis B vaccination in the past do not require additional passive or active immunization. Postvaccination testing should be done 1–2 months after the original vaccine series is completed. In this scenario, the initial postvaccination testing showed that the healthcare professional was protected. Substantial evidence suggests that adults who respond to a hepatitis B vaccine series (anti-HBs of at least 10 mIU/ mL) are protected from chronic HBV infection for at least 30 years, even if there is no detectable anti-HBs currently. Only immunocompromised people (for example, dialysis patients, some HIV-positive people) need to have anti-HBs testing performed periodically. Booster doses of vaccine to maintain their protective anti-HBs concentrations to at least 10 mIU/mL are recommended for dialysis patients and may be given to some HIV-positive patients.
Table 3: Postexposure management of healthcare personnel after occupational percutaneous and mucosal exposure to blood and body fluids, by healthcare personnel HepB vaccination and response status
Healthcare personnel status Postexposure testing Postexposure prophylaxis Postvaccination
serologic
testing†
Source patient
(HBsAg)
HCP testing
(anti-HBs)
HBIG* Vaccination
Documented responder§ after
complete series
No action needed
Documented nonresponder
after 2 complete series
Positive/unknown Not indicated HBIG x2 separated
by 1 month
No
Negative No action needed
Response unknown after
complete series
Positive/unknown <10mIU/mL** HBIG x1 Initiate
revaccination
Yes
Negative <10mIU/mL None
Any result >10mIU/mL No action needed
Unvaccinated/incompletely
vaccinated or vaccine refusers
Positive/unknown —** HBIG x1 Complete
vaccination
Yes
Negative None Complete
vaccination
Yes
Abbreviations: HCP = health-care personnel; HBsAg = hepatitis B surface antigen; anti-HBs = antibody to hepatitis B surface antigen; HBIG = hepatitis B immune globulin.
* HBIG should be administered intramuscularly as soon as possible after exposure when indicated. The effectiveness of HBIG when administered >7 days after percutaneous, mucosal, or nonintact skin exposures is unknown. HBIG dosage is 0.06 mL/kg.
Should be performed 1–2 months after the last dose of the HepB vaccine series (and 6 months after administration of HBIG to avoid detection of passively administered anti-HBs) using a quantitative method that allows detection of the protective concentration of anti-HBs (>10 mIU/mL).
§ A responder is defined as a person with anti-HBs >10 mIU/mL after 1 or more complete series of HepB vaccine.
A nonresponder is defined as a person with anti-HBs <10 mIU/mL after 2 complete series of HepB vaccine.
** HCP who have anti-HBs <10mIU/mL, or who are unvaccinated or incompletely vaccinated, and sustain an exposure to a source patient who is HBsAg-positive or has unknown HBsAg status, should undergo baseline testing for HBV infection as soon as possible after exposure, and follow-up testing approximately 6 months later. Initial baseline tests consist of total anti-HBc; testing at approximately 6 months consists of HBsAg and total anti-HBc.
Source: This table from Prevention of Hepatitis B Virus Infection in the United States: Recommendations of the Advisory Committee on Immunization Practices. MMWR 2018;67(RR-1): 18 www.cdc.gov/mmwr/volumes/67/rr/pdfs/rr6701-H.pdf
Does CDC recommend routine pre-exposure anti-HBs testing of all healthcare personnel who were previously vaccinated?
In general, no, but the type of testing (pre-exposure or post-exposure) depends on the healthcare worker’s profession and work setting. The risk for hepatitis B virus (HBV) infection for vaccinated healthcare personnel (HCP) can vary widely by setting and profession. The risk might be low enough in certain settings that assessment of hepatitis B surface antibody (anti-HBs) status and appropriate follow-up can be done at the time of exposure to potentially infectious blood or body fluids. This approach relies on HCP recognizing and reporting blood and body fluid exposures and might be applied on the basis of documented low risk, implementation, and cost considerations. Trainees, some occupations (such as those with frequent exposure to sharp instruments and blood), and HCP practicing in certain populations are at greater risk of exposure to blood or body fluid exposure from an HBsAg-positive patient. Vaccinated HCP in these settings/occupations would benefit from a pre-exposure approach.
We have a new employee with documentation of having received a series of hepatitis B vaccine as an adolescent. He now tests negative for hepatitis B surface antibody (anti-HBs). How should we manage him?
ACIP recommends that healthcare personnel with written documentation of having received a properly spaced series of hepatitis B vaccine in the past (such as in infancy or adolescence) but who now test negative for anti-HBs should receive a single "booster" dose of hepatitis B vaccine and be retested 1–2 months later. Those who test positive following the "booster" dose are immune and require no further vaccination or testing. Those who test negative should complete a second series of hepatitis B vaccine on the usual schedule and be tested again 1–2 months after the last dose. Heplisav-B may be used to revaccinate new healthcare personnel (including the challenge dose) initially vaccinated with a vaccine from a different manufacturer in the distant past who have anti-HBs less than 10 mIU/mL upon hire or matriculation. For more information see www.cdc.gov/mmwr/volumes/67/rr/pdfs/rr6701-H.PDF, pages 21-22.
 
If an employee receives both HBIG and hepatitis B vaccine after a needlestick from a patient who is HBsAg positive, how long should one wait to check the employee’s response to the vaccine?
Anti-HBs testing for HCP who receive both hepatitis B immune globulin (HBIG) and hepatitis B vaccine can be conducted as soon as 6 months after receipt of the HBIG.
At our facility we do routine pre-employment anti-HBs testing regardless of whether the employee has documentation of a hepatitis B vaccination series and consider those who are anti-HBs positive to be immune. Is this the recommended strategy?
No. HCP with written documentation of receipt of a complete, properly spaced series of hepatitis B vaccine AND a positive anti-HBs can be considered immune to HBV and require no further testing or vaccination. Testing unvaccinated or incompletely vaccinated HCP (including those without written documentation of vaccination) is not necessary and is potentially misleading because anti-HBs of 10 mIU/mL or higher as a correlate of vaccine-induced protection has only been determined for persons who have completed a hepatitis B vaccination series. Persons who cannot provide written documentation of a complete hepatitis B vaccination series should complete the series, then be tested for anti-HBs 1 to 2 months after the final dose.
Is there a recommendation for a routine booster dose of hepatitis B vaccine?
No. HCP who have documentation of receiving a complete series of hepatitis B vaccine and who tested positive for anti-HBs (defined as anti-HBs of 10 mIU/mL or higher) are considered to be immune to hepatitis B. Immunocompetent persons have long-term protection against HBV and do not need further testing or vaccine doses. Some immunodeficient persons (including those on hemodialysis) may need periodic booster doses of hepatitis B vaccine.
Does CDC recommend restarting the hepatitis B vaccine series in the event the series is interrupted?
No. The series should not be restarted. Continue the series from where you left off.
Several physicians in our group have no documentation showing they received hepatitis B vaccine. They are relatively sure, however, that they received the doses many years ago. What do we do now?
Because there is no documentation of vaccination, a vaccination series should be administered and postvaccination testing should be performed 1–2 months after the final dose of vaccine. There is no harm in receiving extra doses of vaccine. Postvaccination testing results should also be documented, including the date testing was performed. All healthcare settings should develop policies or guidelines to assure valid hepatitis B immunization.
An employee thinks she had 3 doses of hepatitis B vaccine in the past but has no documentation of receiving those doses. Before reading the recommendations to revaccinate her, we obtained an anti-HBs titer and the result was greater than 10 mIU/mL. With this lab result, can't we assume she is immune?
No. A positive anti-HBs indicates that the vaccinated person is immune at the time the person was tested but does not assure that the person has long-term immunity. Long-term immunity has been demonstrated only for people attaining an adequate anti-HBs result of at least 10 mIU/mL after completing a full vaccination series. The most direct way to deal with this is to vaccinate the employee with a series of hepatitis B vaccine; test for anti-HBs in 1–2 months and document the result in the employee's health record. An adequate anti-HBs result from a documented vaccine series would assure not only seroprotection, but long-term protection.
I'm a nurse who received the hepatitis B vaccine series more than 10 years ago and had a positive follow-up titer (at least 10 mIU/mL). At present, my titer is negative (less than 10 mIU/ mL). What should I do now?
Do nothing. Data show that vaccine-induced anti-HBs levels might decline over time; however, immune memory (anamnestic anti-HBs response) remains intact following immunization. People with anti-HBs concentrations that decline to less than 10 mIU/mL are still protected against HBV infection. For HCP with normal immune status who have demonstrated adequate anti-HBs (at least 10 mIU/ mL) following full vaccination, booster doses of vaccine or periodic anti-HBs testing are not recommended.
If an employee does not respond to hepatitis B vaccination (employee has had two full series of hepatitis B vaccine), does s/he need to be removed from activities that expose her/him to bloodborne pathogens? Does the employer have a responsibility in this area beyond providing vaccine?
No. There are no regulations that require removal from job situations where exposure to bloodborne pathogens could occur; this is an individual policy decision within the organization. OSHA regulations require that employees in jobs where there is a reasonable risk of exposure to blood be offered hepatitis B vaccine. In addition, the regulation states that adequate personal protective equipment be provided and that standard precautions be followed. Check your state OSHA regulations regarding additional requirements. If there are no state OSHA regulations, federal OSHA regulations should be followed. Adequate documentation should be placed in the employee record regarding non-response to vaccination. HCP who do not respond to vaccination should be tested for HBsAg and total anti-HBc to determine if they have chronic HBV infection. If the HBsAg and total anti-HBc tests are positive, HCP should receive appropriate counseling for preventing transmission to others as well as referral for ongoing care to a specialist experienced in the medical management of chronic HBV infection. Persons who are HBsAg-positive and who perform exposure-prone procedures should seek counsel from a review panel comprised of experts with a balanced perspective (for example, infectious disease specialists and their personal physician[s]) regarding the procedures that they can perform safely. They should not be excluded from work. People who test negative for HBsAg should be considered susceptible to HBV infection and should be counseled about precautions to prevent HBV infection and the need to obtain HBIG prophylaxis for any known or likely exposure to HBsAg-positive blood (see Table 3).
Can a person with chronic HBV infection work in a healthcare setting?
Yes. HCP should not be discriminated against because of their hepatitis B status. All HCP should practice standard precautions, which are designed to prevent HBV transmission, both from patients to HCP and from HCP to patient. There is, however, one caveat concerning HBV-infected HCP. Those who have HBV levels 1000 IU/mL or 5000 genomic equivalents/mL or higher should not perform exposure-prone procedures (for example, gynecologic, cardiothoracic surgery) unless they have sought counsel from an expert review panel and been advised under what circumstances, if any, they may continue to perform these procedures. For more information on this issue, see "Updated CDC Recommendations for the Management of Hepatitis B Virus–Infected Health-Care Providers and Students," MMWR, 2012; 61(RR03):1-12. This document is available at www.cdc.gov/mmwr/pdf/rr/rr6103.pdf.
Vaccine Safety Back to top
Is hepatitis B vaccine safe?
Yes. Hepatitis B vaccines have been demonstrated to be safe when administered to infants, children, adolescents, and adults. Since 1982, more than an estimated 70 million adolescents and adults and more than 50 million infants and children in the United States have received at least one dose of hepatitis B vaccine; more than a billion doses of hepatitis B vaccine have been given worldwide. Vaccination causes a sore arm occasionally, but serious reactions are very rare.
Is it safe to give hepatitis B vaccine to a pregnant woman?
Yes. Many years of experience with hepatitis B vaccines indicates no apparent risk for adverse events to a developing fetus. Current vaccines contain noninfectious HBsAg and pose no risk to the fetus. If the mother is being vaccinated because she is at risk for HBV infection (for example, a healthcare worker, a person with a sexually transmitted disease, an injection drug user, a person with multiple sex partners, or a person with diabetes who is 19 through 59 years of age), vaccination should be initiated as soon as her risk factor is identified during the pregnancy. HBV infection affecting a pregnant woman might result in severe disease for the mother and chronic infection for the newborn.
There are no clinical studies of Heplisav-B in pregnant women. Available human data on Heplisav-B administered to pregnant women are insufficient to assess vaccine-associated risks in pregnancy. Until safety data are available for Heplisav-B, providers should continue to vaccinate pregnant women needing hepatitis B vaccination with a vaccine from a different manufacturer.
Does a birth dose of vaccine increase the risk of elevated temperature and subsequent microbiologic evaluations?
No. Administration of hepatitis B vaccine soon after birth has not been associated with an increased rate of elevated temperatures or subsequent evaluations for possible sepsis in the first 21 days of life.
Contraindications and Precautions Back to top
Who should not receive hepatitis B vaccine?
A serious allergic reaction to a prior dose of hepatitis B vaccine or a vaccine component is a contraindication to further doses of hepatitis B vaccine. The recombinant vaccines that are licensed for use in the United States are synthesized yeast cells into which a plasmid containing the gene for HBsAg has been inserted. Purified HBsAg is obtained by lysing the yeast cells and separating HBsAg from the yeast components by biochemical and biophysical techniques. People with a severe allergic to yeast should not be vaccinated with vaccines produced in yeast cells.
As with other vaccines, vaccination of people with moderate or severe acute illness, with or without fever, should be deferred until the illness improves. Vaccination is not contraindicated in people with a history of multiple sclerosis, Guillain-Barrč syndrome, or autoimmune diseases such as systemic lupus erythematosis or rheumatoid arthritis.
Vaccine Storage and Handling Back to top
How should hepatitis B vaccine be stored?
All hepatitis B-containing vaccine should be stored at refrigerator temperature at 2°C to 8°C (35°F to 46°F). The vaccines must not be frozen. Any vaccine exposed to freezing temperature should not be used. Do not use these or any other vaccines after the expiration date shown on the packaging. Any vaccine administered after its expiration date should be repeated.
 
This page was updated on July 25, 2018.
This page was reviewed on May 12, 2018.
 
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