Protective antibodies to hepatitis B virus in haemophiliacs.

Haemophilic patients are at increased risk from hepatitis B virus infection because of their need for blood product therapy. They are potentially poor responders to hepatitis B vaccine due to immunological abnormalities resulting from two causes: infection with the human immunodeficiency virus and treatment with clotting factor concentrates. The protective antibody response to hepatitis B virus in vaccinated haemophiliacs was investigated using a competitive enzyme-linked immunosorbent assay which employs a monoclonal antibody, RF-HBs-1, that recognises a virus-neutralising epitope on HBsAg. Serum samples from 55 haemophilic patients were studied at 7, 12, and 24 months after the first injection with HB vaccine. Twenty-four vaccinated normal subjects were used as controls. The level of neutralising antibody was found to correlate with the polyclonal anti-HBs response in the majority of subjects in both the control and patient groups. There was a small but statistically significant reduction in both antibody responses in the patients compared with the normal controls. Treatment with FVIII or FIX concentrate did not influence the antibody response in the patients. Eleven of the haemophilic patients were anti-HIV seropositive. This group had a significantly lower antibody response than anti-HIV negative patients, and this correlated with the duration of anti-HIV seropositivity, rather than with their T4 counts. We conclude that, following vaccination, the majority of haemophiliacs are able to mount a protective antibody response to hepatitis B virus. HIV infection was found to be the sole cause of immunological suppression of this response.