No, gestational diabetes is not classified as a risk factor for acute hepatitis B infection. The increased risk of acute hepatitis B infection has been associated with type 1 and type 2 diabetes; however, all people age 59 years or younger are now recommended to be vaccinated against hepatitis B.
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 HepB. Please refer to the Immunize.org 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.
Serologic testing for immunity after HepB 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 anti-HBs testing of certain adults is recommended for the following reasons:
Testing should be performed 1 to 2 months after the last dose of vaccine.
Sexually transmitted infections, including hepatitis B, can be transmitted by sexual assault. Unless the victim has a documented history of completed HepB vaccination, a series of HepB 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 (HBIG) is not necessary.
Neither the Advisory Committee on Immunization Practices (ACIP) nor the manufacturers address the timing of vaccination and dialysis. People 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.
Recommendations for immunocompromised people, such as hemodialysis patients, are different than those for immunocompetent people. Hemodialysis patients who do not respond to an initial vaccine series should be revaccinated with two to four additional doses of HepB (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 HepB 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 HepB should be given and annual anti-HBs testing should be continued. Retesting immediately after the booster dose is not necessary.
There is no maximum number of HepB 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.
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). Heplisav-B and PreHevbrio have not been evaluated for use in dialysis patients.
When using Engerix-B or Recombivax HB brands of HepB to vaccinate hemodialysis or other immunocompromised people, a higher dose is recommended, 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 clinical judgment. Heplisav-B and PreHevbrio have not been evaluated for use in dialysis or pre-dialysis patients.
The safety and effectiveness of Heplisav-B and PreHevbrio have not been established for adult patients on hemodialysis. ACIP recommendations only address the use of Engerix-B or Recombivax HB in this population at this time.
Twinrix (GSK) 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 hepatitis A and who are recommended to receive hepatitis B vaccination, such as certain international travelers, people with chronic liver disease, men who have sex with men, people who use drugs, or to people who want to be immune to both diseases.
A standard Twinrix series consists of 3 doses given intramuscularly on a 0, 1, and 6 month schedule.
In March 2007, the FDA 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 some people traveling imminently. Twinrix cannot be used for post-exposure prophylaxis.
No. Twinrix contains 50% less hepatitis A antigen component than Havrix, GSK’s monovalent HepA [720 vs. 1440 El. U.], so the patient would not receive the recommended dose of HepA antigen.
Minimum intervals for Twinrix are 4 weeks between dose #1 and dose #2, and 5 months between dose #2 and dose #3.
It seems tempting to wait for screening test results, but since this is a 2- or 3-dose series that most adults need, we do not recommend missing an opportunity to vaccinate. Vaccination today helps protect a person who needs it. Even for specialists who work with patient groups with an increased likelihood of previous infection, such as people who use injection drugs, we encourage administering the first dose just after screening (at the same visit). If results show no further vaccination is needed then the vaccine series can be stopped at that point. If the results show further vaccination is needed, as it will with most people, then only one or two more doses will be needed to complete the series.
Because HepB vaccination is a series of 2 or 3 doses of vaccine, and because most older adults need vaccination, we recommend initiating the series whenever and in whatever setting the opportunity arises. There’s no downside to vaccinating, but delaying vaccination could leave someone vulnerable to infection. Patients who are vaccinated should be informed of the recommendation for a one-time triple panel screening test in the future.
Draw the blood for screening first. It is possible to detect HBsAg from the HepB vaccine in serologic tests up to 18 days after vaccination, so CDC recommends obtaining blood for the screening triple panel before administering the first dose of vaccine to avoid any chance of a false positive HBsAg result. If the triple panel screening test needs to be done later, wait one month after administration of the most recent dose of HepB vaccine.
CDC’s General Best Practice Guidelines for Immunization states that, in general, you should only accept written records as proof of vaccination. If the person’s recollection is wrong, and the person is susceptible, then not vaccinating leaves them at ongoing risk.
If you have no record of HepB vaccination and you intend to do the triple panel screen, it is reasonable to proceed with giving the first dose of HepB vaccine after drawing blood for screening. If that triple panel screening test shows evidence that further vaccination is not needed, or if the patient locates records later, then discontinue vaccination at that point. If screening is not done, and records are unavailable, complete the series. If you screen the patient after a partial HepB vaccination series, the screening results might show a positive anti-HBs antibody; however, you should complete the vaccine series to ensure the patient develops the intended long-term protection from infection.
The triple panel is important for vaccinated adults to find out if they have evidence of current or past infection, which could have occurred before vaccination. Antiviral treatment may be needed in certain situations.
For most people the answer is NO. A negative anti-HBs result is a common finding when tested years after completing vaccination, and most healthy people may be reassured that they would still be protected from illness, if exposed.
Antibody titers naturally drift lower over the years; however, studies have shown that the majority of people who were effectively immunized decades earlier can mount an effective antibody response and prevent symptomatic or chronic infection after exposure. A study of members of the Alaskan Native population published in 2022 estimated that 86% had effective protection 35 years following vaccination. Even those few with serologic evidence of hepatitis B infection at some point after vaccination showed no evidence of active infection, which is the most important health outcome.
Revaccination is indicated for certain people at ongoing high risk, as specified in the 2018 ACIP recommendation (e.g., nonresponder infants born to people who tested positive for HBsAg, health care providers at risk of occupational exposure, and people on hemodialysis or with significant immunocompromise). For further details, see the 2018 ACIP recommendation, pages 23 and 24: www.cdc.gov/mmwr/volumes/67/rr/pdfs/rr6701-H.pdf.
There are 4 different HepB vaccines approved for adults, plus the Twinrix (GSK) combination HepA-HepB vaccine. While all of the HepB vaccines licensed for adults are acceptable and recommended, with no preference among them expressed by ACIP, some of the differences among them are outlined below. Clinicians choosing among products may find it useful to consider these differences when making choices for their patient population.
The schedule for Heplisav-B (Dynavax) is 2 doses, given at least one month apart, while all other products require a 3-dose series given over a period of 6 months. Twinrix protects adults against both hepatitis A and B in 3 doses given over 6 months, if vaccination against both is desired. Heplisav-B and PreHevbrio (VBI), both show higher seroconversion rates among some groups that traditionally respond poorly to HepB; the immune response to Engerix-B (GSK) and Recombivax-HB (Merck) declines gradually after age 40, and may be lower in people who are obese or who have diabetes. PreHevbrio is the only HepB product that does not contain yeast, making it is safe for yeast-allergic recipients.
Recombivax-HB and Engerix-B are both recommended when vaccinating during pregnancy; neither Heplisav-B nor PreHevbrio are recommended during pregnancy at this time due to insufficient data available on the safety of these products when given during pregnancy. (Note: testing for pregnancy before HepB vaccination is not recommended.)
If the vaccine type is unknown, but you have documentation, simply pick up the series where you left off and give dose 2 now—you never have to restart the vaccine series. The patient will need a total of three doses since the only 2-dose series option is for Heplisav-B. If you use Heplisav-B, complete the vaccination series by giving a dose now and a second Heplisav-B dose at least 4 weeks later. If you use any other HepB vaccine product, use a minimum interval of 8 weeks between dose 2 and dose 3 to complete the series. See the CDC’s recommended immunization schedule for details, available at www.cdc.gov/vaccines/hcp/imz-schedules/adult-age.html.
In general, this is not an issue, but CDC recommends waiting at least 1 month (4 weeks) after HepB vaccination before drawing blood for the triple panel screen for hepatitis B. HBsAg present in the HepB vaccine has been detected in serologic tests up to 18 days after vaccine administration. You do not have to delay the triple panel screen until after the vaccine series is complete, as long as it’s been at least 4 weeks since the most recent dose.
If you screen the patient after a partial HepB vaccination series, the screening results might show a positive anti-HBs antibody; however, you will still need to complete the vaccine series to ensure the patient develops long-term protection from infection.
There a several potential interpretations of an isolated anti-HBc positive result (with a negative HBsAg and negative anti-HBs). Additional evaluation of the patient’s immune status and risk history is needed. A 2011–2018 national survey found the prevalence of isolated positive anti-HBc is about 0.8%. The total anti-HBc tests are very accurate, at about 99.8% specificity; however, if a person has no risk factors for hepatitis B, the result may be a false positive. Other possibilities include: a past resolved infection; an occult infection (HBV DNA is detectable but surface antigen is not detected); an early infection tested during the brief period of time before anti-HBs antibodies are detectable; or, an infection with a hepatitis B virus with a mutant surface antigen not detectable by standard tests. Depending upon the circumstances, consultation with a specialist may be helpful.
Additional resources for the evaluation of isolated anti-HBc antibody results are available from the University of Washington: www.hepatitisb.uw.edu/go/screening-diagnosis/diagnosis-hbv/ core-concept/all and from CDC: www.cdc.gov/hepatitis-b/hcp/diagnosis-testing/#cdc_hcp_diagnosis_interpreting-how-to-interpret-test-results.
Documentation is very important to the success of the adult HepB catch-up vaccination program. First, give the patient a personal record: let them know that taking a digital photo of their record is wise. Second, all states have an immunization information system, known as an IIS or immunization registry. Check the IIS for the patient’s vaccination records and report doses administered to the IIS to ensure a permanent record of vaccination exists that is accessible to other healthcare providers who need the information. This is the best way to minimize unnecessary repeated hepatitis B evaluation and vaccination in the future.
While breakthrough infections can happen, it is very uncommon in an otherwise healthy young adult. In this scenario, it is unknown when the HBV infection occurred. It is possible that the person had an unrecognized exposure to hepatitis B virus at some time before they were vaccinated: they may even have been born to a hepatitis B-infected mother and infected at birth. This is the reason triple panel screening of every adult, regardless of vaccination history, is recommended. People who decline or defer screening but accept vaccination should understand that vaccination will not alter a pre-existing infection, which is why hepatitis B screening is important for everyone.
The Occupational Safety and Health Administration (OSHA) requires that HepB 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 HepB vaccination sign a declination form. For a fact sheet about this OSHA requirement, go to: www.osha.gov/OshDoc/data_BloodborneFacts/bbfact05.pdf.
As of April 2022, CDC recommends that all people younger than age 60 years be vaccinated against hepatitis B. All adults age 60 or over with risk factors for acquiring hepatitis B (including HCP expected to be exposed to blood and body fluids) also should be vaccinated. Any adult age 60 or older may be vaccinated.
The ACIP HepB vaccine recommendations published in MMWR on January 12, 2018, remain in effect concerning vaccination of healthcare professionals, management of post-vaccination testing for evidence of immunity, revaccination considerations for nonresponders, and post-exposure management. Access these recommendations, beginning on page 18, at www.cdc.gov/mmwr/volumes/67/rr/pdfs/rr6701-H.pdf.
The 2023 CDC recommendation is for all adults to have a triple panel screen for hepatitis B at least once in a lifetime. If the healthcare worker has never been screened, it would be ideal to do the triple panel screen in this situation.
Yes. However, data are limited on the safety and immunogenicity effects when Heplisav-B or PreHevbrio is interchanged with HepB 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 (4 weeks apart) HepB 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, any 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.
The minimal intervals for the 3-dose HepB vaccines 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.
Yes. Many years of experience with Engerix-B and Recombivax HB brands of HepB vaccines indicate no apparent risk for adverse events to a developing fetus. Current HepB products contain noninfectious hepatitis B surface antigen (HBsAg) and should pose no risk to the fetus. If not vaccinated, a pregnant person may contract an HBV infection during pregnancy, which might result in severe disease for the newborn.
Available human data on Heplisav-B and PreHevbrio administered during pregnancy are insufficient to assess vaccine-associated risks in pregnancy. For this reason, until safety data are available for Heplisav-B or PreHevbrio, providers should continue to vaccinate people needing HepB during pregnancy with either Engerix-B or Recombivax HB. Pregnancy testing prior to vaccination is not recommended.
Mothers who breastfeed their babies and need HepB can be vaccinated. Although data are not available to assess the effects of Heplisav-B and PreHevbrio on breastfed infants or on maternal milk production and excretion, there is no theoretical risk to the infant and vaccination with any HepB product is acceptable.
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 individuals 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.
There are two options for healthcare professionals who test negative after completing their first HepB series. The first option is to give one dose of HepB, then retest for anti-HBs. If the result is positive, the person should be considered immune. If negative, the person should receive the remaining doses in the series, and then retest for anti-HBs. If the result is positive, the person should be considered immune. If negative, 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.
The second option is to 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 or PreHevbrio may be used for revaccination following an initial HepB series that consisted of doses from a different manufacturer. Heplisav-B or PreHevbrio 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.
The choice of option 1 and option 2 should be based on epidemiologic considerations and likelihood that the patient is HBsAg positive, since there is a delay in option 1 in determining HBsAg status.
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 HepB 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.
No. Immunocompetent people known to have responded to HepB 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 HepB 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 people living with HIV) 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 people living with HIV.
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
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.
Because CDC recommends, as of March 2023, that all adults receive a triple panel screening test for HBV once in their lifetime, it may be practical to conduct the routine triple panel test on any HCP who needs testing and has not had a triple panel screening test.
ACIP recommends that healthcare personnel with written documentation of having received a properly spaced series of HepB in the past (such as in infancy or adolescence) but who now test negative for anti-HBs should receive a single “booster” or “challenge” dose of HepB 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 2- or 3-dose series of HepB on the usual schedule and be tested again 1–2 months after the last dose. The “booster” dose counts as the first dose in this series. Heplisav-B or PreHevbrio 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.
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.
No. HCP with written documentation of receipt of a complete, properly spaced HepB series 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 HepB vaccination series. Persons who cannot provide written documentation of a complete HepB vaccination series should complete the series, then be tested for anti-HBs 1 to 2 months after the final dose.
No. HCP who have documentation of receiving a complete HepB series 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.
No. The series should not be restarted. Continue the series from where you left off.
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 anti-HBs 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.
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.
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 healthcare professionals 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.
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 HepB 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. People 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).
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.
Yes. HepB vaccines have been demonstrated to be safe when administered to infants, children, adolescents, and adults. Since 1982, well over 100 million people, including infants, children, and adults living in the United States have received at least one dose of HepB vaccine; more than a billion doses of HepB vaccine have been given worldwide. Vaccination causes a sore arm occasionally, but serious reactions are very rare.
Many years of experience with Engerix-B and Recombivax HB vaccines indicate 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 of a risk factor 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), vaccination should be initiated as soon as the risk factor is identified during the pregnancy. HBV infection during pregnancy might result in severe disease for the mother and chronic infection for the newborn.
There are no clinical studies of Heplisav-B or PreHevbrio during pregnancy. Available human data on these products administered during pregnancy are insufficient to assess vaccine-associated risks in pregnancy. Until safety data are available for Heplisav-B or PreHevbrio, providers should continue to use Engerix-B, Recombivax HB, or Twinrix for individuals needing hepatitis B vaccination during pregnancy.
No. Administration of HepB 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.
A serious allergic reaction to a prior dose of HepB or a vaccine component is a contraindication to further doses of HepB. Engerix-B, Recombivax HB, Twinrix, and Heplisav-B are synthesized in yeast cells into which a plasmid containing the gene for HBsAg has been inserted. People with a severe allergic reaction to yeast should not be vaccinated with vaccines produced in yeast cells. PreHevbrio is produced in mammalian cells and may be used (in the absence of other contraindications) in an adult with a severe allergic reaction to yeast.
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-Barré syndrome, or autoimmune diseases such as systemic lupus erythematosus or rheumatoid arthritis.
All hepatitis B-containing vaccines should be stored at refrigerator temperature at 2°C to 8°C (36°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.
