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Hepatitis B

Ask the Experts: Diseases & Vaccines

Hepatitis B

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Hepatitis B
Disease Issues For Childen and Teens
Tests and Interpretation For Adults
Vaccine Recommendations For Healthcare Personnel
Pregnancy, Perinatal, and Infants Chronic HBV Infection
Disease Issues
What are the signs and symptoms of hepatitis B?
About 7 out of 10 people who are 5 years of age or older adults 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 stomach 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 2009, an estimated 38,000 new HBV infections occurred. The most recent fatality rate (2005) among persons with reported cases of acute hepatitis B is 0.5% to 1.0%, with the highest rates in adults age older than age 60 years. A substantial number of infections are asymptomatic and so are not reported, so the overall fatality rate among all persons with HBV infection likely is lower. 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 120 days (range: 45-160 days) after exposure to HBV.
Can HBV be transmitted in daycare via saliva, for example drooling infants?
Although HBV has been found in saliva, there are no data to suggest that saliva alone transmits HBV infection. There have been reports of HBV transmission when an HBV-infected person bites another person. In these reports, bloody saliva was usually present in the infected person's mouth and the blood was more likely the vehicle of transmission. HBV is not spread by kissing, hugging, sneezing, coughing, food or water, sharing eating utensils or drinking glasses, or casual contact.
Can HBV be transmitted by sharing cups or straws?
There are no data to suggest that sharing drinking cups, straws, or other eating utensils, have been associated with HBV transmission; however sharing razors or toothbrushes with an HBV-infected person can transmit the virus.
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.
The Immunization Action Coalition (IAC) has created a website with links to relevant articles from medical journals and publications from national sources such as CDC, the Nemour Foundation, the Alliance of Professional Tattooists, and the Association of Professional Piercers. Feel free to refer patients who are considering one or both of these forms of body art to www.immunize.org/tattoos.
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.
Can "French" kissing transmit HBV?
Although HBV has been found in saliva, there are no data to suggest that kissing transmits HBV; however, there have not been studies to specifically look at "French" kissing.
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 (I don't have one now) 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 transmission. Your sexual partner should have the 3-dose series of hepatitis B vaccine and postvaccination blood testing 1 to 2 months (no sooner and no later) 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.
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?
Any high level disinfectant that is tuberculocidal will kill HBV. It is important to note that HBV is quite stable in the environment and remains viable for 7 or more days on environmental surfaces at room temperature and is still capable of transmitting HBV despite the absence of visible blood.
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 marker of 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 recovering from acute HBV infection
 2. May be distantly immune, but the test may not be sensitive enough to detect a very low level of anti-HBs in serum
 3. May be susceptible with a false positive anti-HBc
 4. May be chronically infected and have an undetectable level of HBsAg present in the serum 
My daughter was immunized against hepatitis B about 4 years ago. She was recently found "hepatitis B positive" by her gynecologist. Is this possible? Could it be a false positive?
It is possible, but unlikely. The hepatitis B surface antigen (HBsAg) test has high sensitivity and specificity and is quite trustworthy. She might have already been HBsAg positive when she was vaccinated so the vaccine would not have been effective. You should make sure that the positive test was actually HBsAg and not another hepatitis B test, such as anti-HBs (sometimes confusingly referred to as HBsAB) or another test called total hepatitis B core antibody (total anti-HBc). A positive anti-HBs test is expected after vaccination with hepatitis B vaccine, but not a positive total anti-HBc or HBsAg.
If you are certain after careful checking that the test and reported result are correct, you should then make sure the laboratory that did the test repeated the test in duplicate and then did neutralization. If your daughter is ultimately determined to be truly HBsAg positive, she should be referred to a liver disease specialist for counseling and medical evaluation. If this is the case, she likely has chronic (life-long) hepatitis B.
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 for reporting inadequate anti-HBs and 10 or above for reporting adequate anti-HBs. You should check with your lab to be certain this is being done.
Vaccine Recommendations Back to top
Where can I locate CDC's recommendations for hepatitis B vaccination?
To obtain "A Comprehensive Immunization Strategy to Eliminate Transmission of Hepatitis B Virus Infection in the United States. Recommendations of the Advisory Committee on Immunization Practices (ACIP). Part 1: Immunization of Infants, Children and Adolescents," MMWR, December 23, 2005, Vol. 54(RR-16):1-39 go to www.cdc.gov/mmwr/PDF/rr/rr5416.pdf.
For the adult recommendations titled "A Comprehensive Immunization Strategy to Eliminate Transmission of Hepatitis B Virus Infection in the United States. Part II: Immunization of Adults," MMWR, December 8, 2006;55(RR-16):1-25 go to www.cdc.gov/mmwr/PDF/rr/rr5516.pdf.
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.
How long is hepatitis B vaccine protective?
Studies indicate that immunologic memory remains intact for at least 20 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 one is challenged with 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.
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.
Where can I find a CDC document that states that hepatitis B vaccine doesn't have to be restarted if the series is interrupted?
The rationale for the use of interrupted hepatitis B vaccination schedules can be found on page 8 in "A Comprehensive Immunization Strategy to Eliminate Transmission of Hepatitis B Virus Infection in the United States. Recommendations of the Advisory Committee on Immunization Practices (ACIP). Part 1: Immunization of Infants, Children and Adolescents published December 23, 2005. Go to www.cdc.gov/mmwr/PDF/rr/rr5416.pdf. Appendix A of the document, in the paragraph entitled "Interrupted Vaccine Schedules", further explains this issue.
This information is also in "A Comprehensive Immunization Strategy to Eliminate Transmission of Hepatitis B Virus Infection in the United States. Part II: Immunization of Adults," MMWR, December 8, 2006;55(RR-16):1-25. Go to www.cdc.gov/mmwr/PDF/rr/rr5516.pdf in Appendix A under "Interrupted Vaccine Schedules").
Further clarification of interruption of vaccine schedules:
When the hepatitis B vaccine schedule is interrupted, the vaccine series does not need to be restarted.
If the series is interrupted after the first dose, the second dose should be given as soon as possible, and the second and third doses should be separated by an interval of at least 8 weeks.
If only the third dose is delayed, it should be administered as soon as possible, after age 24 weeks (164 days).
It is not necessary to restart the vaccine series for infants switched from one vaccine brand to another, including combination vaccines.
Who should not receive the 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 by Saccharomyces cerevisiae (common baker's yeast), 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 allergic to yeast should not be vaccinated with vaccines containing yeast.
People with a history of serious adverse events, including anaphylaxis, after receipt of hepatitis B vaccine should not receive additional doses. 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-Barrè syndrome, or autoimmune diseases such as systemic lupus erythematosis or rheumatoid arthritis.
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 one month. Studies published in the last several years have found that transient HBsAg-positivity (lasting less than 21 days) can be detected in certain people after vaccination. 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.
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. You should discuss with your laboratory how to distinguish a false positive from a true positive anti-HBc.
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 should receive appropriate management.
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?
You can access the official document and appendices at: www.cdc.gov/mmwr/PDF/rr/rr5416.pdf.
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 HBsAg positive should then be referred for counseling and medical evaluation that will include further testing. If there is reason to suspect acute HBV infection in a pregnant woman, IgM class anti-HBc (IgM anti-HBc) could be done to differentiate acute HBV infection from chronic HBV infection. IgM anti-HBc is the blood test that is positive in acute HBV infection.
Our laboratory screens pregnant women with a hepatitis B panel. Is this correct?
No. A routine hepatitis B panel for screening pregnant women is not advised, nor is it necessary to determine current infection. This practice has led to a number of women being incorrectly labeled as HBsAg positive due to misinterpretation of the results on the lab report. In reporting results, some labs use the nomenclature "HBsAb" rather than the more commonly used term "anti-HBs" to designate antibody to HBsAg. Because the term "HBsAb" is only one character different from "HBsAg," the lab report is subject to misinterpretation and an "immune" woman could be incorrectly labeled as "HBsAg positive". Their infants are given unnecessary postexposure treatment with hepatitis B immune globulin (HBIG) and the women experience unnecessary stress. See the previous question and answer for further HBsAg testing information regarding pregnant women.
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.
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.
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 completely 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.
What can birthing hospitals do to prevent newborns from "falling through the cracks" (missing the birth dose) and becoming infected with HBV?
The two most important things hospitals can do are (1) develop written policies and procedures for giving the birth dose that are based on the recommendations of CDC, American Academy of Pediatrics (AAP), and American Academy of Family Physicians (AAFP) and (2) implement the policies and procedures they've developed. By putting this policy into place, hospitals ensure that every newborn will receive the birth dose prior to hospital discharge. You will find guidelines for implementing birth dose policies in CDC's recommendations on hepatitis B prevention in children, which is available at www.cdc.gov/mmwr/pdf/rr/rr5416.pdf. It is also a good idea to be sure the mother understands that she is HBsAg positive and is instructed to inform the delivery room/maternity staff of this fact.
Effective hospital policies and procedures include establishing standardized admission orders for administration of hepatitis B vaccine as part of routine medical care of all medically stable infants weighing 2 kg (4.4 lb) or more. You can use IAC's "Admission Orders for Labor & Delivery and Newborn Units to Prevent Hepatitis B Virus (HBV) Transmission" (www.immunize.org/catg.d/p2130.pdf) as a model in developing your hospital's admission orders.
Note: According to the CDC recommendations, an order to delay the birth dose until after hospital discharge can be done on a case-by-case basis and only in rare circumstances. Further, it requires that a physician's order to withhold the birth dose and a copy of the original laboratory report indicating that the mother was HBsAg negative during this pregnancy be placed in the infant's medical record.
Delivery hospitals should also enroll in the federally funded Vaccines For Children (VFC) program to obtain free hepatitis B vaccine for administration of the birth dose to newborns who are eligible (that is, Medicaid eligible, American Indian or Alaska Native, underinsured, or uninsured). The VFC information is available at www.cdc.gov/vaccines/programs/vfc/index.html. In addition, many states have made free hepatitis B vaccine available to all infants at birth to help simplify the process. Call your state health department to find out if free hepatitis B vaccine is available at birth for all newborns in your state. State health department phone numbers are available at www.immunize.org/coordinators.
Our hospital is dragging its feet on reinstitution of a policy for the hepatitis B vaccine birth dose. How can I help convince them that this is the standard of care?
Administration of a birth dose of hepatitis B vaccine is standard operating procedure (SOP) and is required for effective postexposure immunoprophylaxis to prevent perinatal HBV infection. Although infants who require postexposure immunoprophylaxis should be identified by maternal HBsAg testing, administering a birth dose to infants, even without HBIG, serves as a "safety net" to prevent perinatal infection among infants born to HBsAg-positive mothers who are not identified, because of errors in maternal HBsAg testing or failure in reporting of test results.
The birth dose provides early protection to infants at risk for infection after the perinatal period. Although infections in young children represented less than 10% of all HBV infections before implementation of routine childhood hepatitis B vaccination, childhood infections resulted in an estimated 30% to 40% of the chronic HBV infections among people who acquired their infections in the United States. Many of these chronic infections would not have been prevented by a selective program of identification and immunization of only infants born to HBsAg-positive mothers.
CDC recommends that all newborns be vaccinated in the hospital prior to hospital discharge. AAP and AAFP have also endorsed these recommendations. CDC recommends the following with regard to administering the birth dose:
All delivery hospitals should implement standing orders for administration of hepatitis B vaccine as part of routine medical care of all medically stable infants weighing 2 kg (4.4 lbs) or more at birth.
All medically stable infants weighing 2 kg or more at birth and born to HBsAg-negative mothers should receive the first dose of vaccine (single-antigen only) before hospital discharge.
On a case-by-case basis and only in rare circumstances, the first dose may be delayed until after hospital discharge for an infant who weighs 2 kg or more and whose mother is HBsAg negative. In this case, a physician's order not to give the birth dose must be written, and a copy of the original HBsAg-negative laboratory report during this pregnancy should be placed in the infant's medical record. The official CDC recommendations for hepatitis B vaccination of children are available at www.cdc.gov/mmwr/pdf/rr/rr5416.pdf.
Administration of a birth dose has been associated with higher rates of on-time completion of the hepatitis B vaccine series. In certain populations, the birth dose has been associated with improved completion rates for other infant vaccines. For more information, go to www.immunize.org/birthdose and www.immunize.org/protect-newborns.
If a mother's HBsAg test result is not available at the time of birth, how should the infant be managed?
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 born to women without documentation of HBsAg test results should receive the first dose of single-antigen hepatitis B vaccine (without HBIG) by 12 hours of birth.
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.
Review the hepatitis B vaccination recommendations for preterm infants who weigh less than 2kg (4.4 pounds), as well as for those premature infants who weigh more.
Preterm infants weighing less than 2 kilograms (kgs) (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 kg at birth:
If maternal HBsAg status is positive: Give hepatitis B immune globulin (HBIG) plus hepatitis B vaccine within 12 hours of birth. Give 3 additional hepatitis B vaccine doses with single-antigen vaccine at ages 1, 2 to 3, and 6 months, or hepatitis B-containing combination vaccine at ages 2, 4, and 6 months (Pediarix) or 2, 4, and 12-15 months (Comvax). Test for HBsAg and anti-HBs 1 to 2 months after completion of at least 3 doses of a licensed hepatitis B vaccine series at age 9 to 18 months, generally at the next well-child visit. 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: Give HBIG plus hepatitis B vaccine within 12 hours of birth. Be sure to test the mother's blood for HBsAg. Give 3 additional hepatitis B vaccine doses with single-antigen vaccine at ages 1, 2 to 3, and 6 months, or hepatitis B-containing combination vaccine at ages 2, 4, and 6 months (Pediarix) or 2, 4, and 12-15 months (Comvax).
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, whichever comes first. Complete the vaccine series per the recommended schedule.
For preterm infants weighing 2 kg or more at birth, follow the recommendations for full-term infants including the birth dose for all, keeping in mind the special needs of newborns whose mother's HBsAg status is positive or unknown.
 
I'm a pediatrician and support the use of the birth dose of hepatitis B vaccine. I give it routinely, but a few parents object. In my practice, almost 100% of my infant patients' mothers are tested for HBsAg and almost all are reported to be negative. Could you tell me how many cases of HBV infection occur each year in babies who are born to documented HBsAg-negative mothers?
Because infants born to HBsAg-negative mothers are usually not tested for HBV infection, and because virtually all HBV infections occurring among infants are asymptomatic, it is not possible to quantify the number of HBV-infected infants born to mothers believed to be HBsAg negative. However, we know that many unvaccinated newborns have been left needlessly at risk of infection because of errors in maternal hepatitis B testing and reporting. In two surveys conducted by IAC covering the period from July 1999 to October 2002, state and local hepatitis B coordinators reported more than 500 medical errors discovered through their perinatal hepatitis B prevention programs. Many of these errors involved misinterpreting or mistranscribing hepatitis B screening test results, or ordering the wrong hepatitis B screening test. Such errors can lead to a woman being documented as HBsAg negative, when she is actually HBsAg positive. Use of the hepatitis B vaccine birth dose safeguards against these maternal hepatitis B testing and reporting errors and also prevents early childhood HBV infections. The birth dose also protects the infants of women who become HBV infected after having been screened in early pregnancy and not tested later in pregnancy.
Preventing possible HBV transmission in early childhood is also a major issue. Seroprevalence data from the National Health and Nutrition Examination Surveys (NHANES) have provided estimates of the number of early HBV infections. Based on these data, approximately 16,000 children younger than age 10 years were infected with HBV beyond the postnatal period each year before routine infant vaccination was recommended in 1991 (Armstrong GL, et al. Childhood hepatitis B virus infections in the United States before hepatitis B immunization. Pediatrics 200l;108(5):1123-28). Although these infections represented only 5% to 10% of all people with chronic HBV infection in the United States at that time, it is estimated that 18% of all people with chronic HBV infection acquired their infections postnatal during early childhood. In some populations, childhood transmission was more important than perinatal transmission as a cause of chronic HBV infection before infant hepatitis B immunization was widely implemented. For example, in studies conducted among children born in the United States with Southeast Asian refugee parentage during the 1980s, approximately 60% of chronic HBV infections in young children were among children born to HBsAg-negative mothers. Since implementation of routine childhood immunization, an estimated 6,800 perinatal HBV infections have been prevented in the United States annually.
Should states and localities establish case-management programs to prevent perinatal HBV infection?
Yes. Case-management programs should be established that include appropriate policies, procedures, laws, and regulations to ensure that all pregnant women are tested for HBsAg during each pregnancy and that infants born to HBsAg-positive women and infants born to women with unknown HBsAg status receive recommended case management. The location of these programs and the methods by which they operate will depend on multiple factors (for example, population density and annual caseload of HBsAg-positive women). Programs might be located in state or local health departments, private healthcare systems (such as health maintenance organizations), or institutions (such as correctional facility systems). Program administrators will need to work with prenatal care providers, delivery hospital staff, pediatric care providers, private healthcare systems, and health departments.
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.
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 postexposure prophylaxis to prevent perinatal HBV infection, there is no increased risk of infection among breastfed infants.
What is the possibility of maternal HBV transmission when breastfeeding an infant if the mother is HBsAg positive and has cracked or bleeding nipples?
As stated before, although HBsAg can be detected in breast milk, there is no evidence that HBV is transmitted by breastfeeding. Babies born to HBsAg-positive mothers should be immunized with hepatitis B vaccine and HBIG, which will substantially reduce the risk of perinatal transmission and protect the infant from modes of postnatal HBV transmission, including the theoretical exposure to HBV from cracked or bleeding nipples during breastfeeding. To prevent cracked and bleeding nipples, all mothers that breastfeed should be instructed on proper nipple care.
Can Comvax or Pediarix be given at birth?
No. Neither of these combination vaccines should be given before age 6 weeks. The use of Comvax prior to age 6 weeks can cause the suppression of the immune response to the Hib component in Comvax. The use of Pediarix prior to age 6 weeks can result in suppression of the immune response to the acellular pertussis component of 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 permitted when giving the monovalent hepatitis B vaccine birth dose followed by the use of combination vaccines Comvax or 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.
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 age 6 months (no earlier than age 24 weeks). See the next question for more information on this issue.
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.
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 an HBsAg-positive mother?
For infants born to HBsAg-positive mothers, postvaccination testing is recommended 1 to 2 months after completion of at least 3 doses of the hepatitis B vaccine series. For a child on schedule this is age 9 to 18 months, generally at the next well-child visit. Testing should not be performed before age 9 months, as HBIG might still be present for 6 to 8 months nor should testing be performed within 1 month of the most recent vaccine dose, as a transient false positive HBsAg might occur. 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.
HBsAg-negative infants with anti-HBs levels of at least 10 mIU/mL are protected and need no further medical management. HBsAg-negative infants with anti-HBs levels less than 10 mIU/mL should be revaccinated with a second 3-dose series and retested 1 to 2 months after the final dose of vaccine.
An infant of an HBsAg-positive mother received appropriate postexposure prophylaxis and tested negative for anti-HBs and HBsAg at 12 months of age. How many more doses of hepatitis B vaccine do I need to give before I retest?
The recommended approach is to complete a second 3-dose series of vaccine and re-test for both HBsAg and anti-HBs 1 to 2 months after the third dose of vaccine. If anti-HBs and HBsAg are still negative after revaccination, the child is considered a non-responder to hepatitis B vaccine.
When screening an adopted infant for hepatitis B, at what age would you expect the infant to not show anti-HBs or anti-HBc if it were passively transferred antibody from the mother?
Passively acquired maternal anti-HBs might be detected until age 6 to 8 months and passively acquired maternal anti-HBc might be detected until age 24 months.
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 endemicity of HBV infection should be tested for HBsAg, regardless of vaccination status. People testing HBsAg positive should be referred for medical evaluation and ongoing follow-up.
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/recs/schedules/child-schedule.htm). 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 screened for HBsAg and have a review of their immunization record 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 approved 2-dose schedule, the adult dose of Recombivax HB (1.0 mL dose containing 10 mcg of HBsAg) 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 among adolescents age 11 through 15 years, 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 doses containing 5 mcg of HBsAg). The overall frequency of adverse events was similar for the 2-dose schedule compared to the 3-dose schedule. Follow-up data indicate that the rate of decline in antibody levels for the 2-dose schedule was similar to that for the 3-dose schedule. No data are available to assess long-term protection (beyond 2 years) or immune memory following vaccination with the 2-dose schedule, and it is not known whether booster doses of vaccine will be required. 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 dose of 5 mcg 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 child 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 licensed 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?
It depends on the schedule and manufacturer of the vaccine that you are using. For children age 11 through 15 years, the 2-dose Recombivax HB volume is 1.0 mL or 10 micrograms. Otherwise the 3-dose schedule of Recombivax HB is 0.5 mL or 5 micrograms and of Engerix-B is 0.5 mL or 10 micrograms. 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
According to the CDC hepatitis B recommendations for adults, which adults should be vaccinated?
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 disease (STD)
Men who have sex with men (MSM)
Current or recent illegal injection drug users
Household contacts of HBsAg-positive people
Residents and staff of facilities for developmentally challenged 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 wwwn.cdc.gov/travel/default.aspx for countries with intermediate or high levels of HBV infection
People with chronic liver disease
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
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 adults are available at www.cdc.gov/mmwr/PDF/rr/rr5516.pdf.
 
Would you please provide details about the recent ACIP recommendations for the use of hepatitis B vaccine in adult diabetic patients
In December 2011, CDC published new 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.
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. See pages 1709-11 of the CDC recommendations Use of Hepatitis B Vaccination for Adults with Diabetes Mellitus.
In which adult healthcare setting(s) is hepatitis B vaccination recommended routinely?
In certain settings, a high proportion of people are likely to be at risk for HBV infection. Examples of these settings are the following:
STD/HIV testing and treatment facilities
Drug-abuse treatment and prevention settings including injection-drug-user (IDU) care settings
Healthcare settings targeting services to MSM
Correctional facilities
Chronic hemodialysis facilities and end-stage renal disease programs
Institutions and non-residential day care facilities for developmentally challenged people
In these settings, CDC recommends universal hepatitis B vaccination for all adults who have not completed the vaccine series. Certain people with risk factors (for example, MSM and IDUs) should be vaccinated against hepatitis A as well. Although a risk assessment is not required in these settings before offering and encouraging hepatitis B vaccine, it still might be useful, and especially for consideration of hepatitis A vaccine, given that not all people visiting these settings are recommended to receive hepatitis A vaccine. A hepatitis A vaccination screening questionnaire is available at: www.immunize.org/catg.d/p2190.pdf. A hepatitis B vaccination screening questionnaire is available at: www.immunize.org/catg.d/p2191.pdf.
How should hepatitis B vaccination be managed in primary care and specialty medical settings?
In primary care and specialty medical settings, CDC recommends implementation of standing orders for identifying adults recommended for hepatitis B vaccination and for administering vaccination as part of routine services. To ensure vaccination of adults at risk for HBV infection who have not completed the vaccine series, CDC recommends the following:
Provide information to all adults regarding the health benefits of hepatitis B vaccination, including risk factors for HBV infection and people for whom vaccination is recommended
Help all adults assess their need for vaccination by obtaining a history that emphasizes risks for sexual transmission and percutaneous or mucosal exposure to blood
Vaccinate all adults who report risk(s) for HBV infection
Vaccinate all adults requesting protection from HBV infection, without requiring them to acknowledge a specific risk factor
A hepatitis B vaccination screening questionnaire is available at www.immunize.org/catg.d/p2191.pdf. Standing orders for administering hepatitis B vaccine to adults are also available at www.immunize.org/catg.d/p3076.pdf.
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. For men and women who weigh less than 130 pounds (less than 60 kg), a 5/8-inch needle is sufficient to ensure intramuscular injection in the deltoid muscle if the injection is made at a 90-degree angle and the tissue is not bunched. For men and women who weigh 130 to 152 pounds (60 to 70 kg), a 1-inch needle is sufficient. For women who weigh 152 to 200 pounds (70 to 90 kg) and men who weigh 152 to 260 pounds (70 to 118 kg), a 1- to 1 1/2 -inch needle is recommended. For women who weigh more than 200 pounds (more than 90 kg) or men who weigh more than 260 pounds (more than 118 kg), a 11/2-inch needle is recommended.
I want to be able to start vaccinating adults at increased risk of HBV infection in our clinic; however, we know that many of them are uninsured or have minimal insurance coverage. Is there any way that we can get free vaccine from CDC?
CDC does not provide vaccine directly to clinicians. The availability of free or low cost vaccine from other sources is variable. Some states have special programs that make hepatitis B vaccine available for certain groups of adults with increased risk of HBV infection. Check with your state immunization program manager or hepatitis B coordinator on the availability of low-cost or free vaccine. A list of state immunization program managers and a list of hepatitis B coordinators is available at: www.immunize.org/coordinators.
 
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.
 
I still am not clear about the need for testing if the hepatitis B vaccine series was completed many years ago. Please advise.
All healthcare personnel (HCP) with risk of exposure to hepatitis B should be tested 1 to 2 months after receiving the third dose of hepatitis B vaccine. CDC does not recommend testing healthcare personnel who were not tested within the 1 to 2 month postvaccination time frame. HCP who are exposed can be tested as part of postexposure management, if indicated. For more information, see Hepatitis B and Healthcare Personnel, available at www.cdc.gov/mmwr/pdf/rr/rr6007.pdf.
 
For which workers in healthcare settings does the Occupational Safety and Health Administration (OSHA) require that hepatitis B vaccine be provided?
OSHA requires that hepatitis B vaccine be provided free of charge to HCP who have reasonably anticipated contact with blood or body fluids on the job. This requirement does not include HCP who would not be expected to have occupational risk, such as billing staff and 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.
If a person has been sexually assaulted, should he/she be offered HBIG and hepatitis B vaccine?
There have been no studies to determine the risk of HBV infection following sexual assault. However, it is known that other STDs are transmitted following such episodes. So hepatitis B post-exposure prophylaxis to victims of sexual assault should be provided. Unless the victim has a documented history of completed hepatitis B vaccination, hepatitis B vaccine alone on a 0-, 1-, 6-month vaccination schedule should be administered with the first dose as soon as possible after the assault. There is no need to give HBIG for the following reasons: 1) vaccine alone has high efficacy in post-exposure prophylaxis in people exposed to chronic HBV infection; 2) HBIG is only needed to improve efficacy of postexposure prophylaxis of sex contacts of people with acute HBV infection. In most cases, it could be assumed that if the rapist were HBV infected, he/she would have chronic HBV infection, not acute HBV infection, and hence might be less infectious. For details, please refer to Appendix B of CDC's adult hepatitis B recommendations at: www.cdc.gov/mmwr/PDF/rr/rr5516.pdf.
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 three or four additional doses of hepatitis B vaccine (depending on the brand) using the dialysis-specific dosing regimen. 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.
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 postexposure 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 (hepatitis A-hepatitis B vaccine; GSK)?
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).
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.
Is it safe for HCP 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 can and should be vaccinated against hepatitis B if needed. Receipt of the vaccine is not a reason to discontinue breastfeeding.
Which HCP need serologic testing after receiving 3 doses of hepatitis B vaccine?
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 who have the 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 person's postvaccination anti-HBs test is negative (less than 10 mIU/mL) 1–2 months after the last dose of vaccine?
Repeat the 3-dose series and test for anti-HBs 1–2 months after the third dose of vaccine. 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 3-dose 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 3-dose hepatitis B vaccine series (anti-HBs of at least 10 mIU/ mL) are protected from chronic HBV infection for at least 22 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 (>3 doses)
No action needed
Documented nonresponder
after 6 doses
Positive/unknown —** HBIG x2 separated
by 1 month
No
Negative No action needed
Response unknown after
3 doses
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 4–6 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 >3 doses of HepB vaccine.
A nonresponder is defined as a person with anti-HBs <10 mIU/mL after >6 doses 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 was adapted from "CDC Guidance for Evaluating Health-Care Personnel for Hepatitis B Virus Protection and for Administering Postexposure Management," MMWR, 2013; 62(RR10):1–19; www.cdc.gov/mmwr/pdf/rr/rr6210.pdf
In December 2013, CDC released a new document titled CDC Guidance for Evaluating Health-Care Personnel for Hepatitis B Virus Protection and for Administering Postexposure Management (MMWR 2013;62[RR-10]) available at www.cdc.gov/mmwr/pdf/rr/rr6210.pdf. Does the content of this document update ACIP recommendations on healthcare personnel vaccination and hepatitis B?
The new guidance published by CDC was created based on the opinions of an expert panel convened by CDC. According to the document, the guidance from CDC "augments the 2011 recommendations" of the ACIP document titled Immunization of Health-Care Personnel published November 25, 2011 (www.cdc.gov/mmwr/pdf/rr/rr6007.pdf), for evaluating hepatitis B protection among healthcare personnel and administering postexposure prophylaxis.
Does CDC now 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 postexposure) depends on the healthcare worker’s profession and work setting. An expert panel convened by CDC acknowledged that 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. The guidance document provides an algorithm for settings where the choice is to use a pre-exposure approach and IAC has made it available as an educational material at www.immunize.org/catg.d/p2108.pdf. Table 3 provides the algorithm when postexposure management is implemented.
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 4 months after receipt of the HBIG. However, a new recommendation in the 2013 document is to test for hepatitis B core antibody (anti-HBc) and hepatitis B surface antigen (HBsAg) among certain HCP (those previously unvaccinated, incompletely vaccinated, or revaccinated) with an exposure from an HBsAg-positive or unknown HBsAg-status patient at the time of the exposure and approximately 6 months after the exposure (that is, after the HBV incubation period). The CDC expert panel determined that it would be more efficient to do all the follow-up testing at one time, and recommended testing at 6 months after the exposure. Anti-HBs could be measured at a minimum of 4 months after the administration of HBIG, but testing for infection would then follow approximately 2 months later.
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 properly spaced 3-dose 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 3-dose series, then be tested for anti-HBs 1 to 2 months after the final dose.
Is there now a recommendation for a routine booster dose of hepatitis B vaccine?
No. HCP who have documentation of receiving a 3-dose 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, as described in the 2006 adult hepatitis B vaccine ACIP recommendations (MMWR 2006;55[RR-16]:26–9). These recommendations have not changed.
Does CDC now recommend restarting the hepatitis B vaccine series in the event the series is interrupted?
No. This recommendation has not changed. The series should not be restarted. Simply continue 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, the 3-dose vaccination series should be administered and postvaccination testing should be performed 1–2 months after the third dose of vaccine. There is no harm in receiving extra doses of vaccine. Care should always be taken to document vaccine lot, date, manufacturer, route, and vaccine dosages. 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 3-dose 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 3-dose 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?
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.
Chronic HBV Infection Back to top
What does the term "chronic HBV infection" mean?
Chronic infection with HBV refers to life-long HBV infection. The risk of progressing to chronic infection from acute infection is age dependent (less than 5% of people over age 5 years; 30% of children age 1 through 5 years; and up to 90% of infants). People with chronic HBV infection can infect others and are at increased risk of serious liver disease including cirrhosis and liver cancer. In the United States, CDC data from 2009 indicate that an estimated 800,000 to 1.4 million people are living with chronic hepatitis B. An annual 3000 deaths due to chronic liver disease associated with viral hepatitis are estimated to occur.
A person is considered to have chronic HBV infection if he or she is (1) HBsAg positive on two occasions at least 6 months apart, or (2) HBsAg positive and IgM class anti-HBc negative on a single blood draw (an IgM class anti-HBc test will be positive for 4 to 6 months after acute HBV infection). For information on the recommendations for identification and public health management of people with chronic HBV infection see: www.cdc.gov/mmwr/preview/mmwrhtml/rr5708a1.htm
What are some important Do's and Don'ts for people with chronic HBV infection?
DO's
Cover all cuts and open sores with a bandage
Discard used items such as bandages and menstrual pads carefully so no one is accidentally exposed to your blood
Wash hands well after touching your blood or infectious body fluids
Clean up blood spills. Then clean the area again with a bleach solution (one part household chlorine bleach to 10 parts of water)
Tell your sex partner(s) you have hepatitis B so they can be tested and vaccinated (if not already infected or vaccinated). Partners should be tested for adequate anti-HBs 1 to 2 months (no sooner and no later) after three doses of vaccine are completed to be sure the vaccine worked
Use a condom during sex unless your sex partner has had hepatitis B or has been immunized and has had a blood test demonstrating immunity to HBV infection. Condoms might also protect you from other sexually transmitted diseases.
Tell household members to see their doctors for testing and vaccination for hepatitis B
Tell your doctors that you are chronically infected with HBV
See your doctor every 6 to 12 months to check your liver for abnormalities, including cancer
If you are pregnant, tell your doctor that you have HBV infection. It is critical that your baby is started on hepatitis B vaccine and HBIG within a few hours of birth
DONT's
Don't share chewing gum, toothbrushes, razors, washcloths, needles for ear or body piercing, personal injection equipment, glucometers or other diabetes
testing equipment or anything that might have come in contact with your blood or infectious body fluids
Don't pre-chew food for babies
Don't share syringes and needles
Don't donate blood, plasma, body organs, tissue, or sperm
Should all HBsAg-positive adults and children be referred to specialists in liver disease such as a hepatologist or gastroenterologist?
All HBsAg-positive adults and children should have a medical evaluation to determine whether they have active liver disease (for example, liver enzymes, biochemical tests of liver function) and whether they are candidates for antiviral therapy. Depending on your practice situation or setting, this can be done by referral or consultation with a physician knowledgeable about chronic viral hepatitis such as a hepatologist, infectious disease specialist, or gastroenterologist.
I understand that if a person is HBeAg negative and HBsAg positive, s/he is not infectious. Am I correct?
No, you are NOT correct. HBsAg-positive people are infectious independent of their HBeAg status. HBeAg-positivity indicates higher levels of HBV in the blood compared to an HBeAg-negative person. A person who is HBsAg positive and HBeAg negative is still infectious, but has lower levels of HBV in their blood.
I have had patients tell me that their doctor said their HBV infection is "in remission." Would you please comment on the appropriateness of this terminology?
"Remission" is not a good term to be used for a persistent infection, such as HBV. HBV infection should be described in terms of virologic markers, infectivity, and evidence of liver disease. Some people might resolve their infection (that is, become HBsAg negative, and so are not infectious) spontaneously or from antiviral therapy. Other people might remain HBsAg positive and infectious, but have no evidence of chronic liver disease (this is the often used term "healthy carriers"). We assume that the use of "remission" in the question might refer to either of these scenarios.
Does giving hepatitis B vaccine to a chronically infected person cause any harm?
No, it will neither harm nor help the person.
What are possible risk factors for developing liver disease among people with chronic HBV infection?
Risk factors for developing liver disease among people with chronic HBV infection include older age, male gender, presence of HBeAg, HBV genotype, mutations in the precore and core promoter regions of the viral genome, and coinfection with hepatitis D (delta) virus. An association between alcohol use and progression to hepatocellular carcinoma in people with chronic hepatitis B has been reported in some studies, but not in others; these discrepancies might be related to accuracy of the alcohol history.
We have a 12-year-old patient who has been HBsAg positive since infancy. Now that the state requires proof of hepatitis B vaccination, what do we do? His mom is less than enthusiastic about telling the school that he is HBsAg positive, and I can't find any recommendations on vaccinating kids in this situation.
We would not vaccinate the child. You should check with your state health department, as states might be different in what they require for declination of vaccination. Depending on state regulations, as the child's physician, you could provide the school with a letter stating that hepatitis B vaccination is not indicated for the child. There is no need to add that the child is HBsAg positive.
 
This page was reviewed on 7/14
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