Safety and Efficacy of a Hepatitis E Virus Vaccine Conducted in Nepal; Conference paper

摘要

Hepatitis E virus (HEV) causes hepatitis E, a public health problem in many developing countries. Several outbreaks of hepatitis E have been reported in military environments. We evaluated the safety and efficacy of a HEV recombinant protein (rHEV) vaccine in a randomized, double-blinded, placebo- controlled trial. In Nepal, we studied 2,000 healthy adults susceptible to HEV who were randomized to receive 3 doses of either the rHEV vaccine (1,000) or placebo (1,000) at months 0, 1 and 6. Active and hospital surveillance were used to identify acute hepatitis and adverse events. The primary endpoint was hepatitis E occurring after 3 vaccine doses.