A "vaccine non-responder" is a person who does not develop protective surface antibodies after completing two full series of the hepatitis B vaccine and for whom an acute or chronic hepatitis B infection has been ruled out.
Although the majority of persons vaccinated against hepatitis B successfully respond to vaccination, an estimated 5-15% of persons may not respond. It is possible that a person who does not respond to the vaccine may already be infected with hepatitis B. Therefore, testing for the presence of the virus (HBsAg) is recommended before diagnosing a person as a "vaccine non-responder".
CDC Recommendations for Vaccine Non-responders
- Persons who do not respond to the primary vaccine series (i.e., anti-HBs <10 mIU/mL) should complete a second 3-dose vaccine series or be evaluated to determine if they are HBsAg-positive.
- Revaccinated persons should be retested at the completion of the second vaccine series. Persons who do not respond to an initial 3-dose vaccine series have a 30%--50% chance of responding to a second 3-dose series.
- Persons exposed to HBsAg-positive blood or body fluids who are known not to have responded to a primary vaccine series should receive a single dose of HBIG and restart the hepatitis B vaccine series with the first dose of the hepatitis B vaccine as soon as possible after exposure. Alternatively, they should receive two doses of HBIG, one dose as soon as possible after exposure, and the second dose 1 month later.
- The option of administering one dose of HBIG and restarting the vaccine series is preferred for non-responders who did not complete a second 3-dose vaccine series.
- For persons who previously completed a second vaccine series but failed to respond, two doses of HBIG are preferred.
- Non-responders to vaccination who are HBsAg-negative should be considered susceptible to HBV infection and should be counseled regarding precautions to prevent HBV infection and the need to obtain HBIG prophylaxis for any known or probable percutaneous or permucosal exposure to HBsAg-positive blood.
- Non-responders to vaccination who prove to be HBsAg-positive should be counseled regarding how to prevent HBV transmission to others and regarding the need for medical evaluation.