Abstract
HEV, a positive ssRNA and nonenveloped virus, is endemic in many developing countries and one of the most frequent causes of acute hepatitis after fecal–oral transmission. Pregnant women are at particular risk for a fatal course of disease, including maternal and fetal mortality. Recent reports indicate that HEV genotype 3, possibly related to zoonotic transmission, may cause chronic hepatitis in some immunosuppressed organ transplant patients. Various approaches have been conducted to develop HEV vaccines, but only one candidate, a recombinant HEV (rHEV) vaccine generated from Spodoptera frugiperda-9 cells by baculoviruses expressing the HEV capsid antigen, has reached clinical Phase I and II trials so far. These trials suggest that the rHEV vaccine is safe and can prevent clinically overt acute hepatitis E in high-risk populations. We herein review the different approaches in HEV-vaccine development and critically discuss the current status and future directions of the rHEV vaccine used in clinical trials.
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