Prevalence of vaccine‐induced escape mutants of hepatitis B virus in the adult population in China: A prospective study in 176 restaurant employees

Abstract

Background and Aim: Hepatitis B virus (HBV) variants with mutations in the S gene would pose a substantial risk to the community as current HBV vaccines are not effective in preventing infection with them. The majority of such vaccine escape mutants so far reported have been found while studying vertical transmission of HBV; the vaccine failure rate in connection with vaccine escape mutants in adults is not clear at the moment. The purpose of this study was to evaluate the efficacy of immunization against HBV in the adult population by analysis using polymerase chain reaction (PCR) to detect HBV‐DNA, and also to elucidate the type of mutation encountered in vaccine failure cases. Method: A total of 176 adult restaurant employees in China, who had been vaccinated according to the food epidemic law, were enrolled in a standard vaccination program. Their serum HBV‐DNA was determined before and 1 year after the completion of the vaccination program. In those infected with HBV, despite having received the HBV vaccine, direct sequencing within the S gene of the amplified samples was conducted. Results: Although only two cases were found to be hepatitis B surface antigen (HBsAg) positive 1 year after the completion of the vaccination program, six subjects (3.4%) were found to be HBV‐DNA positive assessed by a nested PCR. Four out of these six cases had a point mutation within the ‘a’ determinant; they were Gly‐145‐Ala, and Ile/Thr‐126‐Asn/Ser. Conclusion: The HBV vaccine failure rate assessed by using PCR analysis was 3.4% (six of 176) in the Chinese adult population undergoing the HBV vaccination program. Hepatitis B virus variants with missense mutation within the ‘a’ determinant were responsible in most cases.