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Hepatitis E virus is a common cause of illness worldwide and is associated with severe complications, especially in pregnant women. In this report, the long-term efficacy, immunogenicity, and safety of a hepatitis E vaccine are described. Hepatitis E virus (HEV) is a common cause of acute hepatitis worldwide. 1 , 2 HEV infection occurs in two distinct epidemiologic patterns. 3 The most common pattern is waterborne infection, which is caused by HEV genotype 1 or 2 and occurs mainly in resource-limited countries, often in large, protracted outbreaks or in sporadic cases associated with high mortality among pregnant women. 4 – 6 The other pattern is transmission from animals and humans, which is caused by HEV genotype 3 or 4 and occurs widely in both resource-limited and developed countries. 1 , 7 – 9 Rein et al. 10 estimated the incidence of hepatitis E in areas . . .

The effectiveness of the hepatitis E vaccine in high-risk groups, such as chronic hepatitis B (CHB) patients, remains understudied. A key clinical manifestation of CHB is the persistent positivity of hepatitis B surface antigen (HBsAg). We conducted a test-negative design study involving 2,926 HBsAg-positive individuals (born 1941–1991; median age 49.0; male-to-female ratio of 1.4), identified through a hepatitis surveillance system, as part of the phase 3 trial (NCT01014845) of the recombinant hepatitis E vaccine HEV 239 (Hecolin). This system monitored suspected hepatitis cases and performed diagnoses across 11 townships in Dongtai, Jiangsu, China, from 2007 to 2017. Vaccine effectiveness of HEV 239 was assessed by comparing vaccination status between confirmed 96 hepatitis E cases and 2830 test-negative controls, using logistic regression adjusted for sex and age. We found that HEV 239 vaccination was associated with a reduced risk of hepatitis E among HBsAg-positive individuals, with an estimated effectiveness of 72.1% [95% confidence interval (CI) 11.2–91.2], and 81.5% (95% CI 35.9–94.6) among phase 3 trial participants. Our findings show that HEV 239 is highly effective in HBsAg-positive adults, supporting its future recommended use in this population. Effectiveness of the hepatitis E vaccine HEV 239 amongst high-risk groups isn’t well studied. Here, Zhuang et al. analyse a decade of surveillance data (2007–2017) from Dongtai, China, and estimate HEV 239 effectiveness of 72% amongst hepatitis B virus infected people.

Hepatitis E virus (HEV) is a major public health concern in developing countries where the primary transmission is via contaminated water. Zoonotic HEV cases have been increasingly described in Europe, Japan, and the United States, with pigs representing the main animal reservoir of infection. We report an unusual acute hepatitis infection in a previously healthy man caused by a rat HEV with a considerably divergent genomic sequence compared with other rat HEV strains. It is possible that rat HEV is an underrecognized cause of hepatitis infection, and further studies are necessary to elucidate its potential risk and mode of transmission.

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. 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. 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. 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. 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.

The management of viral hepatitis in the setting of pregnancy requires special consideration. There are five liver-specific viruses (hepatitis A, B, C, D, E), each with unique epidemiology, tendency to chronicity, risk of liver complications and response to antiviral therapies. In the setting of pregnancy, the liver health of the mother, the influence of pregnancy on the clinical course of the viral infection and the effect of the virus or liver disease on the developing infant must be considered. Although all hepatitis viruses can harm the mother and the child, the greatest risk to maternal health and subsequently the fetus is seen with acute hepatitis A virus or hepatitis E virus infection during pregnancy. By contrast, the primary risks for hepatitis B virus (HBV), hepatitis C virus (HCV) and hepatitis D virus are related to the severity of the underlying liver disease in the mother and the risk of mother-to-child transmission (MTCT) for HBV and HCV. The prevention of MTCT is key to reducing the global burden of chronic viral hepatitis, and prevention strategies must take into consideration local health-care and socioeconomic challenges. This Review presents the epidemiology of acute and chronic viral hepatitis infection in pregnancy, the effect of pregnancy on the course of viral infection and, conversely, the influence of the viral infection on maternal and infant outcomes, including MTCT. The management of viral hepatitis in the setting of pregnancy requires special consideration. This Review examines each hepatitis virus individually to address the effect of pregnancy on the natural history of infection and how the viral infections influence maternal and infant outcomes, including mother-to-child transmission. Key points Acute hepatitis A virus (HAV) infection during pregnancy might increase the rates of adverse pregnancy outcomes; cases leading to fetal liver injury and mother-to-child transmission (MTCT) of HAV have been reported. Pregnant women with chronic hepatitis B virus (HBV) infection might have an increased risk of preterm delivery and gestational diabetes. There is risk of MTCT of HBV, especially in mothers with high levels of HBV DNA, but this risk is reduced with the use of maternal antiviral therapy and prompt administration of infant immunoprophylaxis. Pregnant women with chronic hepatitis C virus (HCV) infection have increased rates of adverse pregnancy outcomes; MTCT occurs in 5% and is linked with invasive fetal monitoring and prolonged rupture of membranes. Risks related to underlying cirrhosis can be more frequent in pregnant women with hepatitis D virus (HDV) infection; MTCT of HDV is rare and management is the same as HBV monoinfection. Acute hepatitis E virus (HEV) infection in pregnancy is associated with an increased risk of maternal death and infant mortality, including higher rates of preterm delivery and stillbirths; MTCT of HEV can occur.

The first recombinant hepatitis E vaccine (Escherichia Coli), Hecolin® (Xiamen Innovax, China), was approved for people aged ≥16 years. Innovax has developed a thiomersal-free formulation process change according to the requirement of 2020 Chinese Pharmacopoeia. This study aimed to evaluate the safety and immunogenicity of the thiomersal-free hepatitis E vaccine compared with the licensed hepatitis E vaccine in people aged ≥16 years. Clinical Trial Registration: NCT06564116. This was a single-center, randomized, double-blind, active-controlled study conducted in China. Eligible participants were randomly assigned in a 1:1 ratio to the thiomersal-free hepatitis E vaccine group (HEV-TF group) or the hepatitis E vaccine group (HEV group) stratified by sex and age. Each participant received three doses of the vaccine intramuscularly at 0, 1 and 6 months. Safety was evaluated based on adverse events (AEs) occurred within 30 days following each dose, serious adverse events (SAEs) and pregnancy events occurred during the study period. Immunogenicity was evaluated through quantification of anti-HEV IgG in serum samples collected at 0 and 7 months. A total of 612 eligible participants were enrolled and received at least 1 dose of vaccine. 558 participants were included in the per protocol set for immunogenicity. All participants seroconverted in both groups by month 7. The seroconversion rate difference was 0.00 % (95 % confidence interval [CI] -1.38 to 1.34). The geometric mean concentrations (GMCs) in HEV-TF group and HEV group were 16.57 U/mL and 18.47 U/mL, respectively. The GMC ratio was 0.90 (95 % CI 0.79 to 1.01). The overall AEs rates were similar between the groups (16.88 % vs. 12.50 %). Most of AEs were grade 1 or 2. No vaccine-related SAE occurred during the study period. The thiomersal-free hepatitis E vaccine demonstrated non-inferior immunogenicity compared with the licensed hepatitis E vaccine Hecolin® and showed an acceptable safety profile.

Hepatitis E viruses (HEV) cause hepatitis E in humans. In industrialized countries, sporadic HEV infections, typically caused by HEV genotypes 3 or 4, can become chronic and progress to liver cirrhosis in immunocompromised individuals. Pigs are a significant animal reservoir, implicating raw or undercooked pork products as potential sources of human infection. To better understand HEV dissemination in the Belgian pig population, potential risk factors were investigated by linking farm-level HEV serological status to biosecurity questionnaire data. Farrow-to-finish herd type, free-range systems, and poor boot hygiene were significantly associated with higher within-herd prevalences. This enabled an initial risk profiling of various farming types and the development of predictions for all Belgian pig farms. When combined with the census of the Belgian wild boar population, the predicted HEV status of all professional Belgian pig farms (based on these associations) does not suggest that the proximity of wild boars is a main source of HEV in free-ranging herds. Identifying risk factors for increased circulation of HEV between and within pig farms is critical to controlling its spread and reducing human infection.

Seroprevalence studies suggest that one third of the world's population has been infected with hepatitis E virus (HEV). Infection, especially during pregnancy, is associated with substantial rates of death and complications. No vaccine or specific therapy has been available for the treatment of HEV infection. In this double-blind, placebo-controlled trial involving 2000 subjects in Nepal, the administration of three doses of a novel recombinant HEV vaccine had 95.5% efficacy. Seroprevalence studies suggest that one third of the world's population has been infected with hepatitis E virus (HEV). In this trial involving 2000 subjects in Nepal, the administration of three doses of a novel recombinant HEV vaccine had 95.5% efficacy. Hepatitis E virus (HEV) infection is a major public health problem in many developing countries. 1 Hepatitis E occurs sporadically and in epidemics, causing substantial rates of death and complications, especially in pregnant women. 2 On the basis of seroprevalence, an estimated one third of the world's population has been infected with HEV. 3 In India, the lifetime infection risk is more than 60%, which translates to hundreds of thousands of illnesses annually. 4 Hepatitis E is usually self-limited and typically occurs in locations where laboratory diagnosis is unavailable. 5 Consequently, the true burden of hepatitis E is unknown. Hepatitis E is clinically indistinguishable from . . .

At least 20 million hepatitis E virus (HEV) infections occur annually, with >3 million symptomatic cases and ∼60,000 fatalities. Hepatitis E is generally self-limiting, with a case fatality rate of 0.5-3% in young adults. However, it can cause up to 30% mortality in pregnant women in the third trimester and can become chronic in immunocompromised individuals, such as those receiving organ transplants or chemotherapy and individuals with HIV infection. HEV is transmitted primarily via the faecal-oral route and was previously thought to be a public health concern only in developing countries. It is now also being frequently reported in industrialized countries, where it is transmitted zoonotically or through organ transplantation or blood transfusions. Although a vaccine for HEV has been developed, it is only licensed in China. Additionally, no effective, non-teratogenic and specific treatments against HEV infections are currently available. Although progress has been made in characterizing HEV biology, the scarcity of adequate experimental platforms has hampered further research. In this Review, we focus on providing an update on the HEV life cycle. We will further discuss existing cell culture and animal models and highlight platforms that have proven to be useful and/or are emerging for studying other hepatotropic (viral) pathogens.

Introduction Hepatitis E virus (HEV) is a leading cause of acute viral hepatitis in South Asia, frequently causing waterborne outbreaks. Despite the recognized past and potential future epidemic burden in Nepal, data on the serological and molecular characteristics of, and co-infections with, Hepatitis A, B, and C viruses remain scarce. This study aimed to perform a detailed virological and serological characterization of a 2014 outbreak in Biratnagar, Nepal, to define the etiology and evaluate diagnostic patterns. Methods In this cross-sectional study, 211 patients with suspected acute viral hepatitis were enrolled from three hospitals in Biratnagar, Nepal, during the outbreak peak (April–May 2014). Serum samples were tested for HEV RNA (qRT-PCR), antigen, IgM, and IgG (ELISA), alongside HAV IgM, HBV core antibody, and HCV antibody. Concordance between HEV markers was assessed using Cohen’s κ, associations with co-infections via Fisher’s exact tests, and clinical correlates with Mann-Whitney U tests. Results HEV marker positivity among the 211 patients was as follows: HEV RNA was detected in 12 patients (5.7%), HEV antigen in 29 patients (13.7%), and HEV IgM in 36 patients (17.1%), indicating acute or recent infection. HEV IgG, reflecting past or recent exposure, was detected in 62 patients (29.4%). All successfully sequenced HEV RNA–positive isolates were identified as genotype 1a, consistent with the predominant HEV genotype reported in Nepal. In contrast, HAV, HBV, and HCV infections were infrequent, each accounting for less than 3% of cases, and no significant co-infections were observed. Concordance between HEV markers was variable, supporting the utility of a combined molecular and serological diagnostic approach to capture infections at different stages. Conclusion This study provides a detailed characterization of HEV markers during the 2014 Biratnagar outbreak and confirms the circulation of HEV genotype 1a. HAV, HBV, and HCV infections were uncommon, with no significant co-infections observed. These findings offer valuable insights into HEV marker distribution and co-infection patterns, which can inform public health strategies, including enhanced surveillance, improved access to safe water, and consideration of targeted vaccination to mitigate future outbreaks in endemic settings.