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.