What to Know About the Heplisav-B Vaccine

Heplisav-B is a vaccine used in adults 18 and over to prevent hepatitis B, a viral infection of the liver. It is one of three vaccines approved by the U.S. Food and Drug Administration (FDA) for the prevention of hepatitis B infection.

Heplisav-B is a recombinant vaccine that stimulates the production of protective antibodies that specifically target the hepatitis B virus (HBV). Recombinant vaccines work by inserting DNA coding from HBV into cells, providing them with instructions on how to produce HBV-specific antibodies.

Heplisav-B is delivered in a series of two injections. One of the major benefits of Heplisav-B is that it requires fewer shots over a shorter period of time compared to the other vaccine options. This better helps ensure that people will complete the vaccination series rather than stopping short.

Uses

Heplisav-B is a newer vaccine option used for the primary immunization of hepatitis B in adults 18 and over. Immunization is the process of making a person immune to infection either by vaccination or exposure to natural infection.

With hepatitis B, natural exposure is not an option as it can lead to chronic infection, a condition that may be controlled but is not curable. In some, chronic HBV infection can lead to cirrhosis, liver failure, and liver cancer.

Hepatitis B is caused by exposure to HBV-infected blood and, to a lesser extent, bodily fluids like semen.

The Advisory Committee on Immunization Practices (ACIP), a panel of experts that's part of the CDC, recommends HBV vaccination for all unvaccinated adults ages 59 and younger, and adults ages 60 and up who have risk factors for HBV, including:

• People who have sex with someone who has hepatitis B
• Sexually active individuals who are not in a long-term, mutually monogamous relationship
• People seeking testing or treatment for a sexually transmitted disease
• Men who have sex with men
• People who share needles, syringes, or other drug paraphernalia
• Healthcare professionals and others at risk of blood exposure
• People who live in the same household as someone with hepatitis B
• Residents and staff of facilities for developmentally challenged people
• People with end-stage kidney disease who require dialysis
• People with chronic liver disease, including hepatitis C
• People living with HIV
• People with diabetes
• Incarcerated people
• International travelers to regions with moderate to high rates of hepatitis B
• Anyone who requests HBV vaccination

Before Use

Heplisav-B is generally considered safe for use in adults. The only absolute contraindication is a severe allergy to a previous dose of any hepatitis B vaccine or to any component of Heplisav-B, including yeast. It should also be used with extreme caution in people with a severe yeast allergy as the vaccine is cultivated from yeast cells.

Other Hepatitis B Vaccines

There are two other hepatitis B vaccines, both of which are approved for people of all ages and delivered in three intramuscular injections:

• Engerix-B
• Recombivax HB

There is also a combination vaccine called Twinrix that protects against both hepatitis A and hepatitis B. It is only approved for use in adults 18 and over and is delivered in a series of three or four injections.

A non-vaccine option called HepaGam B is sometimes used to protect against infection in people who have been exposed to HBV through sex or contact with infected blood (including maternal blood during childbirth). It is a form of immunoglobulin therapy in which protective antibodies are harvested from donated blood. It is not used for primary immunization.

Dosage

Heplisav-B is supplied in disposable, prefilled syringes, each of which contains 0.5 milliliters (mL) of the vaccine. The injections are administered by a healthcare professional.

Heplisav-B is not interchangeable with any of the other hepatitis B vaccines.

Modifications

Immunocompromised people—including organ transplant recipients, people with HIV, and those undergoing chemotherapy or hemodialysis—may not attain the same level of protection due to their diminished immune response.

For these individuals, an additional dose of Heplisav-B may be needed to achieve protection. This can be determined by performing an HBV antibody test one to two months after completion of the primary series. If the antibody levels are below 10 milli-international units per milliliter (mIU/mL), revaccination would usually be advised.

Side Effects

As with all vaccines, Heplisav-B may cause side effects, although they tend to be mild and transient. Severe side effects, while possible, are relatively rare.

Common

Pre-market clinical trials have reported the following side effects (in order of frequency) among recipients of Heplisav-B:

• Injection site pain
• Fatigue
• Headache
• Malaise
• Injection site redness
• Injection site swelling

Fever can also occur, usually mild. Most side effects tend to be mild and resolve within a day or so. Call your healthcare provider if you experience unusual, persistent, or worsening side effects.

Severe

Severe side effects are rare with Heplisav-B. Arguably, the most serious concern is the risk of a potentially life-threatening, whole-body allergy known as anaphylaxis. Pre-market clinical trials reported no such incidents.

With that said, the Institute of Medicine concluded that there is a causal link between the HBV vaccination and anaphylaxis in yeast-sensitive people. Even so, the incidence is only around one per every 1.1 million doses.

Warnings and Interactions

Animal studies involving Heplisav-B have suggested a potential for fetal complications, but no well-controlled human studies are available. The potential benefits may warrant the use of the drug despite the potential risks.

If pregnant or planning to get pregnant, speak with your healthcare provider to fully understand the benefits and risks of HBV vaccination in your case.

Heplisav-B may interact with immunosuppressants. This category of drugs, which blunts the immune response, may impede the body's ability to produce protective antibodies.

Let your healthcare provider know if you take any of the following before getting vaccinated:

• Biologic drugs like Humira (adalimumab) and Xeljanz (tofacitinib)
• Chemotherapy drugs, including alkylating agents like Cytoxan (cyclophosphamide) and antimetabolites like Gemzar (gemcitabine)
• Cyclosporine, used to prevent organ transplant rejection and acute symptoms of inflammatory bowel disease (IBD)
• Disease-modifying antirheumatic drugs (DMARDs), including methotrexate
• High-dose corticosteroids, including prednisone

People undergoing radiation therapy should also advise their healthcare provider before getting vaccinated. Depending on the individual, the vaccination may need to be delayed or the vaccine dosage increased.