Abstract：Objective To study whether HBsAg-HBIG immunogenic complex therapeutic vaccine (YIC) could induce S gene immune escape mutants.Methods Five chronic hepatitis B patients who had been treated with 6 injections of either 30 or 60 micrograms of YIC were recruited for this study. These patients were those who responded to YIC treatment, shown as a drop in serum HBV DNA virus load >2 log10, with serum HBeAg converted to negative at 24 weeks. However, their virus load rebound at the end of 24 weeks follow-up. As controls, one was a patient who did not respond to YIC treatment and remained serum HBV DNA positive at similar level during and after treatment, while the other one was a patient immunized with the alum placebo. Serum samples before treatment and 6 months after termination of treatment were collected, and DNA extracted. PCR was used to amplify HBV S gene, the precore/core gene and the core promoter regions followed by sequencing.Results In all 7 patients treated with YIC or alum no S gene mutation was found in the “a” determinant, nor was precore stop codon mutation detected. However, three patients had mutations in the 1762/1764 core-promoter region, other two patients had mutations in the core promoter region other than the 1762/1764 double mutation.Conclusion The rebound of HBV replication in five YIC-treated patients was not due to the emergence of HBV S immune-escape mutants.
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