What are the indications for a 4-dose Hepatitis B (Hep B) vaccine series?

From the Guidelines

The four-dose hepatitis B vaccine schedule is specifically indicated for adults on hemodialysis and other immunocompromised adults aged ≥20, using Engerix-B with doses of 40 μg at 0,1,2, and 6 months. This recommendation is based on the most recent guidelines from the Advisory Committee on Immunization Practices (ACIP) in 2022 1. The use of a four-dose schedule for these populations is aimed at enhancing immune response and providing stronger protection against hepatitis B, given their compromised immune status.

Key points to consider in the administration of the four-dose hepatitis B vaccine schedule include:

• The schedule involves doses at 0,1,2, and 6 months for immunocompromised adults, including those on hemodialysis.
• Engerix-B is the recommended vaccine for this schedule, with a higher dose of 40 μg used for adults on hemodialysis and other immunocompromised adults.
• The four-dose regimen is crucial for populations requiring enhanced protection, such as those with immunocompromised conditions.
• It's essential to follow the recommended schedule and dosing to ensure adequate immune response, as indicated by the ACIP guidelines 1.

In clinical practice, it's critical to identify patients who would benefit from the four-dose hepatitis B vaccine schedule and ensure they receive the appropriate doses and follow-up care, including antibody titer checks to confirm adequate immune response 1.

From the FDA Drug Label

For an infant with perinatal exposure to an HBsAg-positive and HBeAg-positive mother, a regimen combining one dose of Hepatitis B Immune Globulin (Human) at birth with the hepatitis B vaccine series started soon after birth is 85%–95% effective in preventing development of the HBV carrier state. Hepatitis B Vaccine should be administered IM in three doses of 0. 5 mL of vaccine (10 μg) each. The first dose should be given within 7 days of birth and may be given concurrently with Hepatitis B Immune Globulin (Human) but at a separate site. The second and third doses of vaccine should be given 1 month and 6 months, respectively, after the first.

The indications for a 4-dose hep B vaccine are not explicitly stated in the provided drug labels. However, the labels do provide information on the administration of hepatitis B vaccine in certain situations, such as:

• Perinatal exposure: A 3-dose series of hepatitis B vaccine is recommended for infants born to HBsAg-positive mothers, with the first dose given within 7 days of birth, and the second and third doses given 1 month and 6 months after the first, respectively.
• Postexposure prophylaxis: The labels do not provide information on a 4-dose hepatitis B vaccine series for postexposure prophylaxis. The FDA drug label does not answer the question.

From the Research

Indications for 4 Dose Hep B Vaccine

The following are indications for a 4 dose Hep B vaccine:

• Individuals with HIV-1 infection, as both 4 intramuscular double-dose and 4 intradermal low-dose regimens have been shown to improve serological response compared to the standard HBV vaccine regimen 2
• Persons with HIV, who are at a higher risk for acquiring HBV and experience more rapidly waning immunity than those without HIV 3
• Individuals with isolated antibodies to HBV core antigen, who may benefit from vaccination against hepatitis B virus (HBV) 4
• HIV-positive adults, who may require a 4 dose vaccine schedule to achieve and maintain seroprotection 3, 5

Patient Characteristics

Patient characteristics that may influence the indication for a 4 dose Hep B vaccine include:

• CD4 cell count: patients with higher CD4 cell counts may respond better to vaccination 2, 5
• HIV viral load: patients with lower viral loads may respond better to vaccination 5
• History of injecting drug use: patients with a history of injecting drug use may be more likely to elicit an anamnestic response to vaccination 4

Vaccine Regimens

Different vaccine regimens that have been studied for a 4 dose Hep B vaccine include:

• 4 intramuscular double-dose regimen: has been shown to improve serological response compared to the standard HBV vaccine regimen 2
• 4 intradermal low-dose regimen: has been shown to improve serological response compared to the standard HBV vaccine regimen 2
• 3 dose vaccine schedule with a booster dose: may be necessary to achieve and maintain seroprotection in some individuals 5