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:

• Adults 18 years of age and older who have a specific risk, or lack a risk factor but want protection. See ACIP Recommended Immunization Schedule for Adults for risk factors.

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. 

For more information, please see:

• Recommendations of the Advisory Committee on Immunization Practices for Use of a Hepatitis B Vaccine with a Novel Adjuvant
• Hepatitis B ACIP vaccine recommendations