Product image of Heplisav B (Hepatitis B Surface Antigen, Cpg 1018) supplied by GNH India

Heplisav B

Active Ingredient:
Hepatitis B Surface Antigen, Cpg 1018
Origin:
EU

Heplisav B (Hepatitis B Surface Antigen, Cpg 1018)

Heplisav B is a recombinant hepatitis B surface antigen vaccine that contains hepatitis B surface antigen and the CpG 1018 adjuvant. It is supplied as an injectable solution for intramuscular administration. The product is marketed in the European Union and is prescribed (Rx) for active immunization against hepatitis B virus. Strength details are not specified in the publicly available labeling, currently official and in the EU.

Manufacturer / TM Owner

Dynavax Gmbh

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Indications & Clinical Uses

Heplisav B is indicated for the prevention of hepatitis B infection in specific populations.

  • Adults 18 years and older who have not been previously vaccinated against hepatitis B.
  • Adolescents 12–17 years of age who are at risk for hepatitis B exposure.
  • Individuals with occupational exposure risk, such as health‑care workers.
  • Persons with chronic liver disease, diabetes, or other conditions that increase susceptibility to hepatitis B.
  • Travelers to regions where hepatitis B is endemic.

Side Effects

The safety profile of Heplisav B includes both common, mild reactions and rare, more serious events.

Common

  • Pain, redness, or swelling at the injection site.
  • Low‑grade fever.
  • Headache or fatigue.
  • Mild muscle aches.
  • Nausea.
  • Mild joint pain.
  • Transient rash.

Serious

  • Severe allergic reaction (anaphylaxis).
  • Guillain‑Barré syndrome (rare).
  • High fever with chills.
  • Neurological symptoms such as weakness or numbness.
  • Severe injection site reaction (e.g., necrosis).
  • Thrombocytopenia.

Precautions & Warnings

Before administering Heplisav B, healthcare providers should consider several precautionary factors to ensure safe use.

  • Known hypersensitivity to any component of the vaccine, including the CpG 1018 adjuvant.
  • History of severe allergic reaction to a previous hepatitis B vaccine.
  • Immunocompromised patients, as response may be reduced.
  • Pregnancy and breastfeeding status, because safety data are limited.
  • Acute moderate or severe illness at the time of vaccination.
  • Use in individuals younger than 12 years, which is not approved.

Avoid Interactions

Heplisav B may interact with other agents; certain combinations should be avoided while others require careful monitoring.

Avoid

  • Concurrent administration of other live vaccines (e.g., measles, mumps, rubella).
  • Simultaneous use of immunosuppressive biologics that could blunt vaccine response.
  • High‑dose chemotherapy administered within 2 weeks of vaccination.

Use with caution

  • Antiviral therapy for chronic hepatitis B, as it may affect serologic testing.
  • Systemic corticosteroids, which may reduce immunogenicity.
  • Blood products or immunoglobulins given within 4 weeks of vaccination.
  • Patients receiving interferon therapy.
  • Interferon therapy may alter immune response to the vaccine.

Frequently Asked Questions

Heplisav B induces active immunity by presenting recombinant hepatitis B surface antigen together with the CpG 1018 adjuvant, which activates Toll‑like receptor 9 and enhances B‑cell and T‑cell responses.

Heplisav B is approved for adults 18 years and older and adolescents 12–17 years of age who have not been previously vaccinated and are at risk of hepatitis B exposure.

The standard schedule consists of two intramuscular doses administered at least one month apart to achieve optimal seroprotection.

Yes, persons with chronic liver disease are considered a priority group for hepatitis B vaccination, including Heplisav B, to reduce the risk of infection.

Typical local reactions include pain, redness, swelling, and occasionally mild rash at the injection site, usually resolving within a few days.

Serious events are rare but may include anaphylaxis, Guillain‑Barré syndrome, severe fever, or neurological symptoms; any such reaction requires immediate medical attention.

Safety data in pregnancy and lactation are limited; vaccination should be considered only if the potential benefit outweighs any theoretical risk.

Live vaccines should not be given concurrently, and immunosuppressive biologics or high‑dose chemotherapy may reduce the vaccine’s effectiveness.

Yes, travelers lacking immunity to hepatitis B are advised to receive Heplisav B as part of pre‑travel health preparation.

The provider should stop the injection, treat the reaction according to standard anaphylaxis protocols, and report the event to pharmacovigilance authorities.

Blood products or immunoglobulins should be given at least four weeks before or after Heplisav B to avoid interference with the immune response.

Heplisav B is administered by intramuscular injection, typically into the deltoid muscle.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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