Immunogenicity and safety of hepatitis e vaccine in healthy hepatitis B surface antigen positive adults

Abstract

A recombinant hepatitis e vaccine, Hecolin®, has been proven safe and effective in healthy adults. as hepatitis B surface antigen (HBsag) positive individuals have a higher risk of poor prognosis after super-infection with hepatitis e virus (HeV), the safety and immunogenicity of Hecolin® in this population should be assessed. The present study is an extending analysis of data from a large randomized controlled clinical trial of Hecolin®. Healthy participants (n = 14,065) without current or previous evidence of chronic liver disease were randomized to receive Hecolin® or placebo (hepatitis B vaccine) and donated their blood samples before vaccination and subsequently over 31 mo. Most of the adverse events were mild and comparable between participants with and without baseline hepatitis B surface antigen (HBsag). No vaccine-related serious adverse events were reported. Rates of serious adverse events in HBsag (+) or HBsag (-) participants were also comparable between both groups. almost all participants in the Hecolin® group seroconverted to anti-HeV one month after full vaccination. The antibody response rates and levels were similar in HBsag (+) and HBsag (-) participants (98.38%, 19.32 Wu/mL vs. 98.69%, 19.00 Wu/mL). The two-year antibody dynamics of HBsag (+) participants overlapped perfectly with those of HBsag (-) participants. In conclusion, the safety and immunogenicity of Hecolin® for HBsag (+) adults is very similar to that for the general population. © 2013 Landes Bioscience.