From the Guidelines
For a patient previously immunized against Hepatitis B who now tests negative for Hepatitis B surface antibody (anti-HBs), a booster dose of the Hepatitis B vaccine is recommended. The patient should receive a single dose of the Hepatitis B vaccine (either Engerix-B 20 mcg or Recombivax HB 10 mcg for adults) intramuscularly in the deltoid muscle. After receiving this booster dose, antibody testing should be performed 1-2 months later to confirm the development of protective immunity (anti-HBs ≥10 mIU/mL) 1. If the antibody level remains negative after this booster, the patient should complete a second full series of Hepatitis B vaccination, consisting of two additional doses given at 1 month and 6 months after the booster dose. This recommendation is based on the understanding that some individuals who were previously immunized may experience waning immunity over time 1. The booster dose typically triggers an anamnestic response in those who were previously adequately immunized, rapidly restoring protective antibody levels. For those who fail to respond to the booster, completing a second series helps ensure protection against Hepatitis B infection, which can lead to serious liver complications including cirrhosis and hepatocellular carcinoma. Key considerations for the immunization schedule include:
- Administering the booster dose as soon as possible after the negative anti-HBs test result
- Performing antibody testing 1-2 months after the booster dose to assess response
- Completing a second full series of vaccination if the antibody level remains negative after the booster dose
- Ensuring that the patient understands the importance of completing the recommended vaccination series to achieve and maintain protective immunity against Hepatitis B infection 1.
From the FDA Drug Label
If Hepatitis B Immune Globulin (Human) is indicated (see Table 1), an injection of 0. 06 mL/kg of body weight should be administered intramuscularly (see PRECAUTIONS) as soon as possible after exposure and within 24 hours, if possible. Consult Hepatitis B Vaccine package insert for dosage information regarding that product. * Hepatitis B Immune Globulin (Human), dose 0. 06 mL / kg IM. † HB Vaccine dose 20 μg IM for adults; 10 μg IM for infants or children under 10 years of age. First dose within 1 week; second and third doses, 1 and 6 months later.
The immunization schedule for a patient previously immunized against Hepatitis B who now tests negative for Hepatitis B surface antibody is as follows:
- HB Vaccine dose: 20 μg IM for adults; 10 μg IM for infants or children under 10 years of age
- Schedule:
- First dose: within 1 week
- Second dose: 1 month later
- Third dose: 6 months later 2
From the Research
Immunization Schedule for Previously Immunized Patients Testing Negative for Hepatitis B Surface Antibody
- The immunization schedule for a patient previously immunized against Hepatitis B (HB) who now tests negative for Hepatitis B surface antibody (anti-HBs) is not explicitly defined in the provided studies 3, 4, 5, 6, 7.
- However, it is mentioned that a titer of anti-HBs antibodies ≥ 10 IU/L has long been considered to be seroprotective 3.
- According to the study by 4, the absence of anti-HBs after vaccination does not necessarily mean absence of immune response, and some individuals may still be protected by low antibody levels or cellular immune memory.
- The study by 5 suggests that coordinated activation of Tfh and B-cell lineages after HB vaccination is involved in the acquisition and maintenance of anti-HBs, and that higher anti-HBs antibody titer acquisition is related to longer term maintenance of anti-HBs.
- There is no clear recommendation for a specific immunization schedule for patients who have previously been immunized against HB and now test negative for anti-HBs, but it is suggested that these individuals may still be protected against HBV infection 3, 4, 7.
- The decision to revaccinate or provide booster doses should be made on a case-by-case basis, taking into account the individual's immune status, medical history, and risk of exposure to HBV 3, 6.