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Although hepatitis E virus (HEV) generally does not cause chronic infection except in immunocompromised individuals, it is a major cause of acute hepatitis globally, with high case fatality rates in pregnant women. In a previous randomized, placebo-controlled, double-blind, phase III trial, researchers in China evaluated the efficacy of a candidate vaccine in healthy adults (NEJM JW Infect Dis Oct 2010 and Lancet 2010; 376:895). Promising results at 19-month follow-up led to licensure of the vaccine in China.
Now, researchers (some of them employees of the vaccine maker) have followed the trial participants for 54 months to determine the vaccine's long-term efficacy, immunogenicity, and safety. During the extended follow-up period, double-bl…