From the Guidelines
Patients who were previously vaccinated for hepatitis B but now have titers showing no immunity (anti-HBs levels <10 mIU/mL) should receive a booster dose of the hepatitis B vaccine, and if necessary, complete a full revaccination series to ensure protection against hepatitis B virus infection. According to the most recent guidelines from the Advisory Committee on Immunization Practices (ACIP) 1, individuals with anti-HBs concentrations of <10 mIU/mL after the primary vaccine series should be revaccinated. The ACIP recommends administration of all doses in the second series, on an appropriate schedule, followed by anti-HBs testing 1–2 months after the final dose.
For adults, this typically consists of three doses of the hepatitis B vaccine (such as Engerix-B or Recombivax HB) given at 0,1, and 6 months. For immunocompromised patients, higher doses may be recommended. After completing the revaccination, titers should be checked 1-2 months later to confirm immunity. This approach is recommended because hepatitis B vaccine-induced immunity can wane over time in some individuals, particularly those who were initially low responders. The booster or revaccination stimulates memory B cells to produce protective antibodies again.
Key points to consider include:
- Anti-HBs levels of ≥10 mIU/mL are generally considered seroprotective 1
- Immunocompetent persons have long-term protection and do not need further periodic testing to assess anti-HBs levels, but immunocompromised persons might need annual testing to assess anti-HBs concentrations 1
- Persons who do not have a protective concentration of anti-HBs after revaccination should be tested for HBsAg, and if the HBsAg test result is positive, the person should receive appropriate management 1
- The ACIP recommends postvaccination serologic testing for certain groups, including health-care and public safety workers, chronic hemodialysis patients, HIV-infected persons, and other immunocompromised persons, as well as sex or needle-sharing partners of HBsAg-positive persons 1
From the FDA Drug Label
Antibody titers ≥10 mIU/mL against HBsAg are recognized as conferring protection against hepatitis B. Patients immunized approximately 3 years previously with plasma-derived vaccine and whose antibody titers were <100 mIU/mL (GMT: 35 mIU/mL; range: 9-94) were given a 20-mcg dose of ENGERIX-B. All patients, including 2 who had not responded to the plasma-derived vaccine, showed a response to ENGERIX-B (GMT: 5,069 mIU/mL; range: 624-15,019)
Patients with low antibody titers may require a booster dose of the hepatitis B vaccine. If a patient's antibody titers are no longer showing immunity, they may need to receive an additional dose of the vaccine to boost their immunity. However, the decision to administer a new series of vaccines should be made on a case-by-case basis, considering the individual's risk factors and medical history. 2
From the Research
Hepatitis B Vaccine Booster
- Patients who have been originally vaccinated for hepatitis B and no longer show immunity may require a new series of vaccines or a booster dose 3.
- A study found that 26% of patients who were vaccinated against hepatitis B lost immunity after a median time of 12 months, suggesting the need for regular follow-up and potential booster doses 3.
- Another study recommended that patients with end-stage renal disease should be followed up regularly for loss of HBV immunity after vaccination and receive a boosting dose when this occurs 3.
Vaccine Schedules and Doses
- Different vaccine schedules and doses have been studied to improve seroconversion rates in patients with end-stage renal disease, including a 6-month schedule starting earlier in chronic kidney disease stages 4 and 5 4.
- A study found that a 6-month vaccination schedule with a third-generation recombinant hepatitis B vaccine resulted in seroprotective anti-HBs levels in 86% of patients who had not responded to a second-generation vaccine 5.
- Another study found that patients with end-stage renal disease who received three 20-μg doses of recombinant HBV vaccine had a seroconversion rate of 83% 6.
Factors Affecting Immune Response
- Factors such as older age, diabetes mellitus, obesity, and low vaccine dose have been identified as risk factors for inadequate anti-HBs response in patients with end-stage renal disease 7.
- A study found that hepatitis B vaccine dose was the only independent predictive factor of impaired antibody response in patients with end-stage renal disease 7.
- Natural infection with hepatitis B has been found to result in more stable and longer-lasting anti-HBs titers compared to vaccination 3.