Safety and immunogenicity of a combined vaccine against hepatitis A and B in patients with autoimmune hepatitis.

Patients with autoimmune hepatitis (AIH) are a group at risk of disease exacerbation or relapse of the underlying disease should they fall ill with infectious hepatitis A (HAV) or B (HBV). Therefore, it seems appropriate to protect this group of persons against HAV and HBV disease by vaccination. An open study evaluated the safety, reactogenicity and immunogenicity of a combined HAV and HBV vaccine in 10 patients with AIH (6 patients aged 1-15 years and four patients aged 16+ years). The vaccine was administered using a three-dose vaccination schedule (0, 1 and 6 months). The vaccine course was well tolerated, safe and did not aggravate the clinical course of the underlying disease. Patients responded with 100% seroconversion for antibody to the HAV vaccine component and geometric mean antibody concentration (GIVIC) comparable to healthy cohorts. Response to the HBV component antigen was comparable to previous reports of HBV vaccination in immune compromised individuals with lower GMC than observed in healthy populations. One month after the third vaccine dose (month 7), all six vaccinees in the 1-15 years age group developed protective levels of anti-HBs as compared to two of the four vaccinees in the 16+ years age group.