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Approximately 5‐10% of individuals who are vaccinated with a hepatitis B (HB) vaccine designed based on the hepatitis B virus (HBV) genotype C fail to acquire protective levels of antibodies. Here, host genetic factors behind low immune response to this HB vaccine were investigated by a genome‐wide association study (GWAS) and Human Leukocyte Antigen  (HLA)  association tests. The GWAS and  HLA  association tests were carried out using a total of 1,193 Japanese individuals including 107 low responders, 351 intermediate responders, and 735 high responders. Classical  HLA  class II alleles were statistically imputed using the genome‐wide SNP typing data. The GWAS identified independent associations of  HLA‐DRB1‐DQB1 ,  HLA‐DPB1  and  BTNL2  genes with immune response to a HB vaccine designed based on the HBV genotype C. Five  HLA‐DRB1‐DQB1  haplotypes and two  DPB1  alleles showed significant associations with response to the HB vaccine in a comparison of three groups of 1,193 HB vaccinated individuals. When frequencies of  DRB1‐DQB1  haplotypes and  DPB1  alleles were compared between low immune responders and HBV patients, significant associations were identified for three  DRB1‐DQB1  haplotypes, and no association was identified for any of the  DPB1  alleles. In contrast, no association was identified for  DRB1‐DQB1  haplotypes and  DPB1  alleles in a comparison between high immune responders and healthy individuals. Conclusion: The findings in this study clearly show the importance of  HLA‐DR‐DQ  (i.e., recognition of a vaccine related HB surface antigen (HBsAg) by specific  DR‐DQ  haplotypes) and BTNL2 molecules (i.e., high immune response to HB vaccine) for response to a HB vaccine designed based on the HBV genotype C. (H epatology  2018).

Key HLA‐DRB1‐DQB1 haplotypes and role of the BTNL2 gene for response to a hepatitis B vaccine