ABSTRACT. Concurrent detection of hepatitis B surface antigen (HBsAg) and anti-HBs antibody or hepatitis B surface E antigen (HBeAg) and anti-HBe antibody in patients with chronic hepatitis B (CHB) infection is well established. However, the clinical implications of these proteins remain largely unknown. In this study, demographic, clinical, and laboratory data from 124,865 patients with chronic CHB infection were analyzed. Viral genotypes were determined by nested polymerase chain reaction. A chemiluminescent assay was applied to measure HBsAg, HBsAb, HBeAg, HBeAb, and HBcAb in sera. Among 124,865 patients with CHB infection, 324 (0.3%) were concurrently positive for HBsAg and anti-HBs, and 206 (0.2%) were concurrently positive for HBeAg and anti-HBe. The HBeAg+/anti-HBe+ group was composed of younger patients (P < 0.05). Subgenotype B2 was prevalent in HBV patients concurrently positive for HBeAg and anti-HBe, while HBV patients positive for both HBsAg and anti-HBs exhibited the C2 subgenotype. Among 530 concurrent patients, 126 (39%) HBsAg+/ anti-HBs+ patients were in the low-replication phase, and 62 (19%) were in the reactivation phase; 87 (42%) HBeAg+/anti-HBe+, and 19 (6%) HBsAg+/anti-HBs+ patients were in the immune clearance phase. In this large-scale analysis, the clinical and viral characteristics of HBV infections with concurrent HBs Ag/antibody or HBe Ag/antibody presentations have been examined, and the results may contribute to the diagnosis and treatment of CHB patients.

In this study, anti-hepatitis B virus (HBV) immunity was evaluated in mice using several regimens of the HBV recombinant protein vaccine HBSS1 that expressed in CHO cells containing S (1-223 aa) and preS1 (21-47 aa) and recombinant adenovirus rAdSS1 vaccine. Further, the protective efficacy of these vaccine regimens was studied in a mouse model. High titres of antigen-specific antibodies and neutralizing activity were elicited in mice after vaccination. However, robust multi-antigen (preS1 and S)-specific cell-mediated immunity (CMI) was only detected in mice primed with HBSS1 and boosted with rAdSS1. Moreover, functional T-cell responses with high levels of cytokines and antigen-specific cytotoxic T-cell responses (CD107a CD8 ) were also detected in the mice. Rapid clearance of hepatitis B surface antigen and HBV DNA in blood and significantly decreased hepatitis B envelope antigen levels were observed in mice immunized with the heterogeneous prime-boost vaccine after hepatitis B virus challenge by hydrodynamic injection (HI) of pCS-HBV1.3. The clearance of HBV correlated well with antigen-specific CMI (Th1 and CTL responses) and cytokine profiles (IFN-γ, TNF-α, IL-2) elicited by vaccination. Taken together, our results might contribute to the development of new human HBV vaccines and a better understanding of the mechanisms underlying immune protection and clearance of hepatitis B virus infection.