Paper of the Month - March, 2011

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Efficacy and safety of a recombinant hepatitis E vaccine in healthy adults: a large-scale, randomized, double-blind placebo-controlled, Phase 3 trial

Zhu FC, Zhang J, Zhang XF et al.
In this study from China, a recombinant hepatitis E vaccine was evaluated for efficacy and safety in healthy adults aged 16–65 years. Patients were randomly assigned to either placebo (hepatitis B vaccine) or three doses of hepatitis E virus 239 (HEV 239) vaccine (30 µg purified recombinant hepatitis E antigen adsorbed to 0.8 mg aluminum hydroxide) at 0, 1, and 6 months. The primary endpoint was prevention of hepatitis E within 12 months from 1 month after the third dose.


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