Summary Background Seroprevalence data suggest that a third of the world's population has been infected with the hepatitis E virus. Our aim was to assess efficacy and safety of a recombinant ...hepatitis E vaccine, HEV 239 (Hecolin; Xiamen Innovax Biotech, Xiamen, China) in a randomised, double-blind, placebo-controlled, phase 3 trial. Methods Healthy adults aged 16–65 years in, Jiangsu Province, China were randomly assigned in a 1:1 ratio to receive three doses of HEV 239 (30 μg of purified recombinant hepatitis E antigen adsorbed to 0·8 mg aluminium hydroxide suspended in 0·5 mL buffered saline) or placebo (hepatitis B vaccine) given intramuscularly at 0, 1, and 6 months. Randomisation was done by computer-generated permuted blocks and stratified by age and sex. Participants were followed up for 19 months. The primary endpoint was prevention of hepatitis E during 12 months from the 31st day after the third dose. Analysis was based on participants who received all three doses per protocol. Study participants, care givers, and investigators were all masked to group and vaccine assignments. This trial is registered with ClinicalTrials.gov , number NCT01014845. Findings 11 165 of the trial participants were tested for hepatitis E virus IgG, of which 5285 (47%) were seropositive for hepatitis E virus. Participants were randomly assigned to vaccine (n=56 302) or placebo (n=56 302). 48 693 (86%) participants in the vaccine group and 48 663 participants (86%) in the placebo group received three vaccine doses and were included in the primary efficacy analysis. During the 12 months after 30 days from receipt of the third dose 15 per-protocol participants in the placebo group developed hepatitis E compared with none in the vaccine group. Vaccine efficacy after three doses was 100·0% (95% CI 72·1–100·0). Adverse effects attributable to the vaccine were few and mild. No vaccination-related serious adverse event was noted. Interpretation HEV 239 is well tolerated and effective in the prevention of hepatitis E in the general population in China, including both men and women age 16–65 years. Funding Chinese National High-tech R&D Programme (863 programme), Chinese National Key Technologies R&D Programme, Chinese National Science Fund for Distinguished Young Scholars, Fujian Provincial Department of Sciences and Technology, Xiamen Science and Technology Bureau, and Fujian Provincial Science Fund for Distinguished Young Scholars.
Summary As a member of the catenin family, expression of δ -catenin and its clinical implication in numerous tumors remain unclear. In the present study, expression of δ -catenin in esophageal ...squamous cell carcinoma (ESCC) and its correlations with patient prognosis were explored. We detected the expression of δ -catenin, by immunohistochemistry, in ESCC tissues from 299 cases and analyzed the correlation between δ -catenin expression and patient clinicopathological features. Compared with a lack of expression in adjacent normal esophageal epithelium (0%, 0/47), the frequency of δ -catenin protein was increased in ESCC tissues to 41.5% (124/299, P < .001) and expression correlated with TNM stage and lymph node metastasis ( P = .025 and .019, respectively). Furthermore, Kaplan-Meier survival analysis revealed that patients with high δ -catenin expression had shorter survival than patients with low expression ( P = .010), and multivariate Cox analysis revealed that high δ -catenin expression was also an independent prognostic factor ( P = .001). In transwell assays, migration of ESCC cells was enhanced by δ -catenin overexpression, whereas proliferation of ESCC cells was unchanged. Together, our results suggest that δ -catenin acts as an oncoprotein when overexpressed in ESCC, and its expression is associated with poor prognosis and malignant cell behavior.
