What to Know About Heplisav-B Vaccine

Heplisav-B is a vaccine used in adults 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 its 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 and saliva.

The Advisory Committee on Immunization Practices (ACIP), a panel of experts who operate under the auspices of the Centers for Disease Control and Prevention (CDC), recommends HBV vaccination for the following adults:

• People who live with or 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 living with HIV
• People who share needles, syringes, or other drug paraphernalia
• Healthcare professionals and others at risk of blood exposure
• People with end-stage kidney disease who require dialysis
• People with chronic liver disease, including hepatitis C
• People with diabetes
• Incarcerated people
• International travelers to regions with moderate to high rates of hepatitis B
• Individuals who have immigrated from countries with moderate to high rates of hepatitis B
• Anyone who considers themselves to be at risk

Before Use

Heplisav-B is generally considered safe for use in adults. Its safety and efficacy in children and teenagers have not yet been established.

The only absolute contraindication to Heplisav-B is a severe allergy to a previous dose of the vaccine. 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 other vaccines used for the prevention of hepatitis B:

• Engerix-B, approved for use from birth through 19 years and given in a series of three injections
• Recombivax HB, approved for use in people of all ages and given in series of three injections

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 avert 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 (by 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 doctor 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

To date, there have been no well-controlled studies in humans investigating the effect of Heplisav-B during pregnancy or breastfeeding. However, an animal study reported no adverse events in either pregnant lab rats or their offspring following a 0.3 mL dose of Heplisav-B.

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

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 doctor know if you take any of the following before getting vaccinated:

• Biologic drugs like Humira (adalimumab) and Xeljanx (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 doctor before getting vaccinated. Depending on the individual, the vaccination may need to be delayed or the vaccine dosage increased.