Hepatitis B and Healthcare Personnelq &A IAC Answers Frequently Asked Questions About How to Protect Healthcare Personnel

Hepatitis B and Healthcare PersonnelQ &A IAC answers frequently asked questions about how to protect healthcare personnel

Experts from the Immunization Action Engerix-B (GSK) or Recombivax HB (Merck) should be vaccinated against hepatitis B if Coalition (IAC) answer your questions may be completed with Heplisav-B. However, they haven’t been previously vaccinated. about hepatitis B (HepB) vaccine. You’ll data are limited on the safety and immunoge- Receipt of the vaccine is not a reason to dis- nicity effects when Heplisav-B is interchanged continue breast-feeding. find additional &Q As about hepatitis B with hepatitis B vaccines from other manufac- There are no clinical studies of Heplisav-B in vaccine on the “Ask the Experts” section turers. When feasible, the same manufactur- pregnant women. Available human data on of immunize.org at www.immunize.org/ er’s vaccines should be used to complete the Heplisav-B administered to pregnant women askexperts/experts_hepb.asp series. However, vaccination should not be are insufficient to assess vaccine-associated deferred when the manufacturer of the previ- risks in pregnancy. Until safety data are avail- ously administered vaccine is unknown or able for Heplisav-B, providers should con- Hepatitis B Vaccination when the vaccine from the same manufac- tinue to vaccinate pregnant women needing turer is unavailable. hepatitis B vaccination with a vaccine from Which people who work in healthcare settings The 2-dose hepatitis B vaccine series only a different manufacturer. need hepatitis B vaccine? applies when both doses in the series consist Is there a recommendation for routine booster The Occupational Safety and Health Adminis- of Heplisav-B. Series consisting of a combi- doses of hepatitis B vaccine? tration (OSHA) requires that hepatitis B vac- nation of 1 dose of Heplisav-B and a vaccine cine be offered to healthcare personnel from a different manufacturer should consist No. HCP who have documentation of receiv- (HCP) who have a reasonable expectation of of 3 total vaccine doses and should adhere ing a complete series of hepatitis B vaccine being exposed to blood or body fluids on the to the 3-dose schedule minimum intervals of and who subsequently tested positive for anti- job. This requirement does not include per- 4 weeks between dose 1 and 2, 8 weeks HBs (defined as anti-HBs of ≥10 mIU/mL) sonnel who would not be expected to have between dose 2 and 3, and 16 weeks between are considered to be immune to hepatitis B. occupational risk (e.g., general office workers). dose 1 and 3. Doses administered at less than Immunocompetent persons who also have the minimum interval should be repeated. followed the protocol, have long-term pro- At what anatomic site should hepatitis B However, a series containing 2 doses of tection against HBV and do not need further vaccine be administered to adults? What needle Heplisav-B administered at least 4 weeks apart testing or vaccine doses. Some immuno- size should be used? is valid, even if the patient received a single deficient persons, including those on hemo- For adults, administer hepatitis B vaccine intra- earlier dose from another manufacturer. dialysis, may need periodic booster doses of muscularly (IM) in the deltoid muscle. A 22- hepatitis B vaccine. to 25-gauge, 1–1½-inch needle should be used. If a person who works in a healthcare setting We have a new employee with documenta- The gluteus muscle should not be used as a had one dose only of hepatitis B vaccine tion of having received a series of hepatitis B site for administering hepatitis B vaccine. For 1 year ago, should the series be restarted? vaccine as an adolescent. He now tests optimal protection, it is crucial that the vac- No. The hepatitis B vaccine series should not negative for hepatitis B surface antibody cine be administered IM, not subcutaneously. be restarted when doses are delayed; rather, the series should be continued from where it (anti-HBs). How should we manage him? Can Heplisav-B be used for vaccinating stopped. ACIP recommends that healthcare personnel healthcare professionals? with written documentation of having received Yes. Heplisav-B (Dynavax) was approved by Is it safe for HCP to be vaccinated during a properly spaced series of hepatitis B vac- the Food and Drug Administration in Novem- pregnancy? cine in the past (such as in infancy or adoles- ber 2017 for persons 18 years of age and Yes. Both Engerix-B [GSK] and Recombivax cence) but who now test negative for anti-HBs older. Heplisav-B contains a novel immunos- HB [Merck]) may be administered during should receive a single “booster” dose of timulatory adjuvant (CpG 1018) that binds to pregnancy. Many years of experience with hepatitis B vaccine and be retested 1–2 months Toll-like receptor 9 to stimulate a directed these two vaccines indicate no apparent risk later (see Figure 1). Those who test positive immune response to HBsAg. It is provided in for adverse events to a developing fetus. Cur- following the “booster” dose are immune a single dose 0.5 mL vial and given as a rent hepatitis B vaccines contain noninfec- and require no further vaccination or testing. 2-dose schedule. The doses should be sepa- tious hepatitis B surface antigen (HBsAg) Those who test negative should complete rated by at least 4 weeks. and should pose no risk to the fetus. If not a second series of hepatitis B vaccine on the vaccinated, a pregnant woman may contract usual schedule and be tested again 1–2 Can Heplisav-B be used to complete a an HBV infection during pregnancy, which months after the last dose. Heplisav-B may vaccination series started with Engerix-B or might result in severe disease for the new- be used to revaccinate new healthcare per- Recombivax HB? born. Women who breastfeed their babies sonnel (including the challenge dose) initially A HepB vaccine series that was begun with and are healthcare professionals can and vaccinated with a vaccine from a different continued on the next page �

Saint Paul, Minnesota • 651-647-9009 • www.immunize.org • www.vaccineinformation.org www.immunize.org/catg.d/p2109.pdf • Item #P2109 (2/20) Hepatitis B and Healthcare Personnel (continued) page 2 of 5

manufacturer in the distant past who have risk of occupational percutaneous or mucosal sure to blood or body fluids (for example, anti-HBs less than 10 mIU/mL upon hire or exposure to blood or body fluids (for example, public safety workers and HCP without direct matriculation. For more information, see HCP with direct patient contact, HCP at risk patient contact) likely is not cost-effective; www.cdc.gov/mmwr/volumes/67/rr/pdfs/ of needlestick or sharps injury, laboratory however, those who do not undergo post- rr6701-H.PDF, pages 21–22. workers who draw, test or handle blood spec- vaccination testing should be counseled to imens) should have postvaccination testing seek immediate testing if exposed. Post-vaccination Anti-HBs Testing for antibody to hepatitis B surface antigen continued on the next page (anti-HBs). Postvaccination testing should be � Which HCP need serologic testing after done 1–2 months after the last dose of vac- receiving a hepatitis B vaccine series? cine. Postvaccination testing for persons All HCP, including trainees, who have a high at low risk for mucosal or percutaneous expo-

figure 1. Pre-exposure Management for Healthcare Personnel with a Measure antibody to hepatitis B surface antigen (anti-HBs)* Documented Hepatitis B Vaccine Series Who Have Not Had Post- vaccination Serologic Testing ▼ ▼

Healthcare personnel (HCP) with documen- anti-HBs <10mlU/mL anti-HBs ≥10 mlU/mL tation of a complete series of HepB vaccine but no documentation of anti-HBs ≥10 mIU/ mL who are at risk for occupational blood or ▼ body fluid exposure might undergo anti-HBs • Administer 1 dose of HepB vaccine. testing upon hire or matriculation. The algo- • Perform postvaccination serologic rithm at right will assist in the management testing 1–2 months after vaccine of these people. It was adapted from CDC. dose.† Prevention of Hepatitis B Virus Infection in the United States: Recommendations of ▼ ▼ ▼ the Advisory Committee on Immunization Practices, MMWR 2018; 67(RR-1), available at anti-HBs anti-HBs www.cdc.gov/mmwr/volumes/67/rr/pdfs/ <10 mlU/mL ≥10 mlU/mL ▼ rr6701-H.pdf. note: Also available as stand-alone form at ▼ www.immunize.org/catg.d/p2108.pdf. • Complete a second series of HepB No action needed for * Pre-exposure serologic testing may be recommended vaccine. hepatitis B prophylaxis for all previously vaccinated HCP who were not tested • P erform postvaccination serologic (regardless of the source 1 to 2 months after the third dose (such as people testing 1–2 months after of the patient’s hepatitis B vaccinated as children or adolescents). Trainees, HCP completion of series.† surface antigen status) in certain occupations, and HCP practicing in certain populations are at greater risk of exposure. Vaccinated HCP in these settings or occupations could benefit ▼ ▼ from pre-exposure serologic testing. anti-HBs anti-HBs † Should be performed 1–2 months after the last dose ▼ of vaccine using a quantitative method that allows <10 mlU/mL ≥10 mlU/mL detection of the protective concentration of anti-HBs (≥10 mlU/mL) (e.g., enzyme-linked immunosorbent assay [ELISA]). ▼ ‡ A nonresponder is defined as a person with anti-HBs <10 mIU/mL after 2 complete series of HepB vaccine. HCP need Persons who do not have a protective concentration of to receive anti-HBs after revaccination should be tested for hepatitis B HBsAg. If positive, the person should receive appropri- evaluation for ate management. See MMWR 2018;67(RR-1) at www. cdc.gov/mmwr/volumes/67/rr/pdfs/rr6701-H.pdf for all exposures‡ guidance on management of persons who do not respond to 2 complete series of HepB vaccine.

What should be done if a person’s postexposure anti-HBs testing for all HCP who istered and postvaccination testing should vaccination anti-HBs test is negative (less than were previously vaccinated but not tested? be performed 1–2 months after the final dose 10 mIU/mL) 1–2 months after the last dose In general, no, but the type of testing (pre- of vaccine. There is no harm in receiving extra of vaccine? exposure or post-exposure) depends on the doses of vaccine. Postvaccination testing Repeat the 2- or 3-dose series (depending on healthcare worker’s profession and work results should also be documented, including vaccine brand) and test for anti-HBs 1–2 setting. The risk for hepatitis B virus (HBV) the date testing was performed. All healthcare months after the final dose of the repeat series. infection for vaccinated HCPs can vary widely settings should develop policies or guidelines Heplisav-B may be used for revaccination by setting and profession. The risk might be to assure valid hepatitis B immunization. following an initial hepatitis B vaccine series low enough in certain settings that assess- I’m a nurse who received a documented series that consisted of doses of Heplisav-B or doses ment of hepatitis B surface antibody (anti- of hepatitis B vaccine more than 10 years ago from a different manufacturer. Heplisav-B HBs) status and appropriate follow-up can be and had a positive follow-up titer (at least may also be used to revaccinate new health- done at the time of exposure to potentially 10 mIU/mL). At present, my titer is negative care personnel (including the challenge dose) infectious blood or body fluids. This approach (<10 mIU/ mL). What should I do now? initially vaccinated with a vaccine from a dif- relies on HCP recognizing and reporting ferent manufacturer in the distant past who blood and body fluid exposures and might be Nothing. Data show that vaccine-induced have anti-HBs less than 10 mIU/mL upon hire applied on the basis of documented low risk, anti-HBs levels might decline over time; how- or matriculation. implementation, and cost considerations. ever, immune memory (anamnestic anti-HBs response) remains intact following immuni- If the test is still negative after a second vac- Trainees, some occupations (such as those with frequent exposure to sharp instruments zation. People with adequate anti-HBs concen- cine series, the person should be tested for trations that have declined to less than 10 HBsAg and total anti-HBc to determine their and blood), and HCP practicing in certain populations are at greater risk of exposure to mIU/mL are still protected against HBV infec- HBV infection status. People who test nega- tion. For HCP with normal immune status tive for HBsAg and total anti-HBc should blood or body fluid exposure from an HBsAg- positive patient. Vaccinated HCP in these who have demonstrated adequate anti-HBs be considered vaccine non-responders and (≥10 mIU/mL) following full vaccination, susceptible to HBV infection. They should be settings/occupations would benefit from a pre-exposure approach. booster doses of vaccine or periodic anti-HBs counseled about precautions to prevent HBV testing are not recommended. infection and the need to obtain hepatitis B At our facility we do routine pre-employment immune globulin (HBIG) prophylaxis for any anti-HBs testing regardless of whether the known or likely exposure to HBsAg-positive Non-responders or HCP with employee has documentation of a hepatitis B Chronic HBV Infection blood. Those found to be HBsAg negative but vaccination series and consider those with total anti-HBc positive were infected in the a positive antibody to be immune. Is this the If an employee does not respond to hepatitis past and require no vaccination or treatment. recommended strategy? B vaccination (employee has had two full If the HBsAg and total anti-HBc tests are pos- series of hepatitis B vaccine), does s/he need itive, the person should receive appropriate No. HCP with written documentation of to be removed from activities that expose counseling for preventing transmission to receipt of a complete, properly spaced series her/him to bloodborne pathogens? others as well as referral for ongoing care to a of hepatitis B vaccine AND a positive anti- specialist experienced in the medical manage- HBs can be considered immune to HBV and No. There are no regulations that require ment of chronic HBV infection. They should require no further testing or vaccination. Test- removal from job situations where exposure to not be excluded from work. ing unvaccinated or incompletely vaccinated bloodborne pathogens could occur; this is an HCP (including those without written docu- individual policy decision within an organiza- How often should I test HCP after they’ve mentation of vaccination) is not necessary and tion. OSHA regulations require that employees, received the hepatitis B vaccine series to make is potentially misleading because anti-HBs in jobs where there is a reasonable risk of sure they’re protected? of 10 mIU/mL or higher as a correlate of vac- exposure to blood, be offered hepatitis B vac- For immunocompetent HCP, periodic testing cine-induced protection has only been deter- cine. In addition, the regulation states that or periodic boosting is not needed. Post- mined for persons who have completed a adequate personal protective equipment be vaccination testing (anti-HBs) should be done hepatitis B vaccination series. Persons who provided and that standard precautions be 1–2 months after the last dose of the hepatitis cannot provide written documentation of a followed. Check your state OSHA regulations B vaccine series. If adequate anti-HBs (at least complete hepatitis B vaccination series should regarding additional requirements. If there 10 mIU/mL) is present, nothing more needs complete the series, then be tested for anti- are no state OSHA regulations, federal OSHA to be done. This information should be made HBs 1 to 2 months after the final dose. regulations should be followed. Adequate documentation should be placed in the employee available to the individual and recorded in his Several physicians in our group have no doc- record regarding non-response to vaccination. or her health record. If postvaccination testing umentation showing they received hepatitis B is less than 10 mIU/mL, the vaccine series vaccine. They are relatively sure, however, HCP who do not respond after 2 complete should be repeated and anti-HBs testing that they received the doses many years ago. series of vaccine should be tested for HBsAg should be completed 1–2 months after the What do we do now? and total anti-HBc to determine if they have last dose of the second series. chronic HBV infection. If the HBsAg and total Because there is no documentation of vacci- Does CDC now recommend routine pre- nation, a vaccination series should be admin- continued on the next page �

anti-HBc tests are positive, HCP should be excluded from work. Yes. HCP should not be discriminated against receive appropriate counseling for preventing Nonresponders who test negative for HBsAg because of their hepatitis B status. All HCP transmission to others as well as referral for should be considered susceptible to HBV should practice standard precautions, which ongoing care to a specialist experienced in the infection. They should be counseled about are designed to prevent HBV transmission, medical management of chronic HBV infec- precautions to prevent HBV infection and the both from patients to HCP and from HCP to tion. People who are HBsAg-positive and who need to obtain HBIG prophylaxis for any known patient. There is, however, one caveat con- perform exposure-prone procedures should exposure to blood that is HBsAg-positive or if cerning HBV-infected HCP. Those who have seek counsel from a review panel comprised the HBsAg status of the source is unknown HBV levels 1000 IU/mL or 5000 genomic of experts with a balanced perspective (e.g., (see Table 1 below). equivalents/mL or higher should not perform infectious disease specialists and their per- exposure-prone procedures (e.g., gyneco- sonal physician[s]) regarding the procedures Can a person with chronic HBV infection logic, cardiothoracic surgery) unless they have that they can perform safely. They should not work in a healthcare setting? sought counsel from an expert review panel continued on the next page �

table 1. Post-exposure management of healthcare personnel after occupational percutaneous and mucosal exposure to blood and body fluids, by healthcare personnel HepB vaccination and response status

Postexposure testing Postexposure prophylaxis Postvaccination Healthcare personnel status Source patient HCP testing serologic HBIG* Vaccination † (HBsAg) (anti-HBs) testing

§ Documented responder after No action needed complete series Positive/ HBIG x2 sepa- Not indicated __ No Documented nonresponder ¶ unknown rated by 1 month after 2 complete series Negative No action needed

Positive/ <10mIU/mL** HBIG x1 unknown Initiate Yes Response unknown revaccination after complete series Negative <10mIU/mL None

Any result ≥10mIU/mL No action needed

Positive/ Complete __** HBIG x1 Yes Unvaccinated/incompletely unknown vaccination vaccinated or vaccine refusers Negative __ None Complete Yes vaccination

* HBIG should be administered intramuscularly as ¶ A nonresponder is defined as a person with anti-HBs abbreviations soon as possible after exposure when indicated. The <10 mIU/mL after 2 complete series of HepB HCP = healthcare personnel effectiveness of HBIG when administered >7 days vaccine. HBsAg = hepatitis B surface antigen after percutaneous, mucosal, or nonintact skin expo- ** HCP who have anti-HBs <10mIU/mL, or who are sures is unknown. HBIG dosage is 0.06 mL/kg. unvaccinated or incompletely vaccinated, and sus- anti-HBs = antibody to hepatitis B surface antigen † Should be performed 1–2 months after the last tain an exposure to a source patient who is HBsAg- HBIG = hepatitis B immune globulin dose of the HepB vaccine series (and 6 months after positive or has unknown HBsAg status, should administration of HBIG to avoid detection of pas- undergo baseline testing for HBV infection as soon sively administered anti-HBs) using a quantitative as possible after exposure, and follow-up testing method that allows detection of the protective con- approximately 6 months later. Initial baseline tests Adapted from CDC. Prevention of Hepatitis B Virus centration of anti-HBs (≥10 mIU/mL). consist of total anti-HBc; testing at approximately Infection in the United States: Recommendations of the Advisory Committee on Immunization Practices, § 6 months consists of HBsAg and total anti-HBc. A responder is defined as a person with anti-HBs ≥10 MMWR 2018; 67(RR-1), available at www.cdc.gov/ mIU/mL after 1 or more complete series of HepB mmwr/volumes/67/rr/pdfs/rr6701-H.pdf. vaccine.

Immunization Action Coalition • Saint Paul, Minnesota • 651-647-9009 • www.immunize.org • www.vaccineinformation.org www.immunize.org/catg.d/p2109.pdf • Item #P2109 (2/20) Hepatitis B and Healthcare Personnel (continued) page 5 of 5 and been advised under what circumstances, source patient (if known) should be tested for For more information on vaccination if any, they may continue to perform these HBsAg as soon as possible after the exposure. recommendations for healthcare personnel, procedures. For more information on this Testing the source patient and the HCP should see the following: issue, see Updated CDC Recommendations occur simultaneously; testing the source 1 CDC. CDC Guidance for Evaluating Health-Care for the Management of Hepatitis B Virus– patient should not be delayed while waiting Personnel for Hepatitis B Virus Protection and Infected Health-Care Providers and Students, for the HCP anti-HBs test results, and like- for Administering Postexposure Management, MMWR, 2012; 61(RR03):1-12. This document wise, testing the HCP should not be delayed MMWR, 2013; 62(10):1–19, www.cdc.gov/ is available at www.cdc.gov/mmwr/pdf/rr/ while waiting for the source patient’s HBsAg mmwr/pdf/rr/rr6210.pdf rr6103.pdf. results. See Table 1 for management recom- 2 CDC. Prevention of Hepatitis B Virus Infection in mendations based on the results of testing. the United States: Recommendations of the Post-exposure Management Advisory Committee on Immunization Practices, If an employee receives both HBIG and MMWR 2018; 67(RR-1), available at www.cdc. How should a fully vaccinated employee with hepatitis B vaccine after a needlestick from gov/mmwr/volumes/67/rr/pdfs/rr6701-H.pdf. an unknown anti-HBs response be managed a patient who is HBsAg positive, how long 3 Immunization Action Coalition. “Healthcare if they have a percutaneous or mucosal expo- should one wait to check the employee’s Personnel Vaccination Recommendations,” sure to blood or body fluids from an HBsAg- response to the vaccine? www.immunize.org/catg.d/p2017.pdf positive or HBsAg-unknown source? Anti-HBs testing for HCP who receive both 4 Immunization Action Coalition. “Pre-exposure Management for Healthcare Personnel (HCP) with hepatitis B immune globulin (HBIG) and Management of the exposed HCP depends a Documented Hepatitis B Vaccine Series Who on both the anti-HBs status of the HCP and hepatitis B vaccine can be conducted as soon Have Not Had Post Vaccination Serologic Testing,” the HBsAg status of the source patient. The as 6 months after receipt of the HBIG. www.immunize.org/catg.d/p2108.pdf HCP should be tested for anti-HBs and the

Immunization Action Coalition • Saint Paul, Minnesota • 651-647-9009 • www.immunize.org • www.vaccineinformation.org www.immunize.org/catg.d/p2109.pdf • Item #P2109 (2/20)