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Heplisav-B® (HepB-CpG) Vaccine

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Advisory Committee on Immunization Practices (ACIP) recommendations

In February 2018, ACIP approved recommendations for Heplisav-B (HepB-CpG) vaccine as an option for previously unvaccinated or incompletely vaccinated persons, including:

 

Screen for contraindications and precautions

  • Do not administer Heplisav-B to individuals with a history of severe allergic reaction (e.g., anaphylaxis) after a previous dose of any hepatitis B vaccine or to any component of Heplisav-B, including yeast.
  • Consult the package insert for precautions, warnings, and contraindications and Hepatitis B Vaccine Safety for additional information and possible side effects.

 

Administer the vaccine correctly

  • Schedule: Administer 2 doses at least 4 weeks apart
  • Dose (volume): 0.5 mL each dose
  • Route: Intramuscular (IM) injection
  • Site: Deltoid muscle is preferred
    • Identify the site carefully using anatomical landmarks. Shoulder injury related to vaccine administration (SIRVA) has been reported after IM injections in the deltoid muscle.
  • See Vaccine Administration and SIRVA infographic [1 page] for more information about proper IM vaccine administration.

 

Interchangeability and Dosing Schedule

  • 2-dose HepB vaccine series only applies when both doses consist of HepB-CpG, administered at least 4 weeks apart.
  • Series consisting of a combination of 1 dose of HepB-CpG and a vaccine from a different manufacturer (HepB-alum) should do the following:
    • 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. However, if HepB-CpG is substituted for dose 2 of HepB-alum, a provider has the option of administering the next dose of HepB-CpG a minimum of 4 weeks from the previous dose for a complete series.
  • Doses administered at less than the recommended minimum interval should be repeated.
  • See Recommended Immunization Schedule for Adults for details. 

 

Special Populations

  • Until safety data are available for HepB-CpG, providers should continue to vaccinate pregnant women needing HepB vaccination with HepB-alum.
  • Postvaccination serologic testing 1–2 months after the final dose of vaccine is recommended for certain persons, including those who are immunocompromised and health care personnel. 

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