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Hepatitis B (HB) vaccines (Heptavax-II and Bimmugen) designed based on HBV genotypes A and C are mainly used for vaccination against HB in Japan. To determine whether there are differences in the genetic background associated with vaccine responsiveness, genome-wide association studies were performed on 555 Heptavax-II and 1193 Bimmugen recipients. Further  HLA  imputation and detailed analysis of the association with  HLA  genes showed that two haplotypes,  DRB1*13:02-DQB1*06:04  and  DRB1*04:05-DQB1*04:01 , were significantly associated in comparison with high-responders (HBsAb > 100 mIU/mL) for the two HB vaccines. In particular,  HLA-DRB1*13:02-DQB1*06:04  haplotype is of great interest in the sense that it could only be detected by direct analysis of the high-responders in vaccination with Heptavax-II or Bimmugen. Compared with healthy controls,  DRB1*13:02-DQB1*06:04  was significantly less frequent in high-responders when vaccinated with Heptavax-II, indicating that high antibody titers were less likely to be obtained with Heptavax-II. As Bimmugen and Heptavax-II tended to have high and low vaccine responses to  DRB1*13:02 , 15 residues were found in the Heptavax-II-derived antigenic peptide predicted to have the most unstable HLA-peptide binding. Further functional analysis of selected hepatitis B patients with  HLA  haplotypes identified in this study is expected to lead to an understanding of the mechanisms underlying liver disease.

Importance of HBsAg recognition by HLA molecules as revealed by responsiveness to different hepatitis B vaccines