Vaccine Therapy in Chronic Hepatitis B Carriers: A Randomised Double-Blind Controlled Trial

Introduction: Chronic carriers of Hepatitis B Virus (HBV) are persistent sources of the virus and may transmit HBV to healthy individuals. Aim: This study was conducted to assess therapeutic effects of HBV vaccine on Chronic HBV Carriers (CHC). Methods and Materials: This clinical trial was conducted on CHCs aged 20-65 years, randomly allocated into four groups. Group 1 (control) did not receive vaccine. Group 2, 3 and 4 (vaccine groups) received different doses of HBV vaccine. HBV viral load (IU/mL) was assessed at baseline and two months after the last dose of HBV vaccine. Reduction or elimination of HBV viral load was considered as positive response. Absolute Response Rates (ARR) was calculated for each group. Subgroup analysis was done on subjects with baseline viral load of <100,000 and negative HBeAb. Relative Response Rates (RRR) was defined as ARR in vaccine group divided by that of control. RRRs were calculated for total participants (overall RRR) and the above-mentioned subgroup of subjects (subgroup RRR). Results: In total, 97 CHCs were recruited. No adverse reaction was reported. There was no significant difference in ARRs between study groups (p-value=0.09). An overall RRR of 0.78 and a subgroup RRR of 1.18 has been reported. A 50% increase was found in the RRR in subgroups of subjects with baseline viral load of <100,000 and negative HBeAb compared to the overall RRR. Conclusion: It may be worth future studies to assess the therapeutic effects of HBV vaccine.