Hecolin (recombinant hepatitis E vaccine) / Wantai BioPharm - LARVOL DELTA

Clinical Guidelines for Hepatitis E Vaccination in India: An Expert Panel Consensus Report on the Recombinant Hepatitis E Vaccine, HEV 239. (PubMed, Pathogens) - "Although derived from HEV genotype 1, the vaccine demonstrated cross-protective efficacy against HEV genotype 4. (4) This consensus report provides a framework for deploying the HEV vaccine to mitigate disease burden in India while emphasizing the need for real-world effectiveness and safety data from India."

Clinical guideline • Journal • Review • Hepatology • Human Immunodeficiency Virus • Infectious Disease • Inflammation • Liver Failure • Solid Organ Transplantation • Transplantation

Safety of hepatitis E vaccine in pregnancy. (PubMed, Virol J) - "Focusing on a landmark study from South Sudan by Nesbitt RC et al., we provide a critical appraisal of its findings, integrate them with prior evidence from clinical trials and animal studies, and discuss implications for vaccination policy in outbreak settings, particularly in fragile and conflict-affected contexts. The comment concludes that vaccination during pregnancy shows no detected increased risk of fetal loss, providing crucial real-world data to inform life-saving vaccination policies, while acknowledging remaining uncertainties."

Journal • Inflammation

Risk factors for spontaneous abortion following hepatitis E vaccination during and shortly before pregnancy: Further analysis from a cluster-randomized trial. (PubMed, PLoS One) - "Our analyses did not uncover associations pointing to a biological mechanism underlying the original observation of an increased SAB rate connected to HEV239 vaccination shortly before or during pregnancy. Targeted studies such as placental examinations and genetic testing are needed to investigate potential mechanisms."

Clinical • Journal • Cardiovascular • Diabetes • Hepatitis B • Hypertension • Infectious Disease • Inflammation • Metabolic Disorders • Pain

Global Temporal Trends and Projections of Acute Hepatitis E Epidemiology for Adults 65 Years and Older from 1990 to 2021: Global Burden of Disease 2021 Based Study. (PubMed, Trop Med Infect Dis) - "Diverging trends of rising incidence and falling mortality highlight unmet prevention needs. High-burden regions require SDI-stratified strategies, prioritizing vaccination programs (e.g., HEV 239), zoonotic transmission control, and enhanced surveillance. The Sustainable Development Goals (SDGs) envision hepatitis elimination by 2030 (Target 3.3). However, our analysis projects ongoing AHE burden in aging populations through 2050, indicating the need for post-2030 policy adaptations."

HEOR • Journal • Inflammation

A modular nanoparticle display strategy for varicella-zoster virus gE based on a licensed protein scaffold. (PubMed, PLoS Pathog) - "Nano-gEVZV demonstrates enhanced antigen uptake by antigen-presenting cells (APCs), improved lymph node retention, and stronger B- and T-cell responses compared with Shingrix in mouse models. While RZV remains the gold standard for herpes zoster prevention, we explored a nanoparticle-based gE display platform as a complementary approach to improve manufacturability and immune presentation."

Journal • Herpes Zoster • Infectious Disease • Inflammation • Varicella Zoster

Long-Term Immunity and IgG Subclass Response Following Hepatitis E Vaccination: A Longitudinal Cohort Study in Matlab, Bangladesh. (PubMed, Int J Infect Dis) - "This research reveals the first long-term IgG subclass-specific and cellular immunity data following HEV 239 vaccination in an endemic population. The findings demonstrate durable immune responses and offer crucial evidence to inform future HEV vaccination strategies for endemic regions like Bangladesh."

Journal • Infectious Disease • Inflammation • IFNG • IL4

Cost-effectiveness Analysis of Hepatitis E Screening and Vaccination: Targeting Vulnerable Populations in Outbreak and Sporadic Settings in China. (PubMed, Emerg Microbes Infect) - "In China, where sporadic settings are more common, preventive universal HEV screening combined with standard 3-dose vaccination is cost-effective only for people with CHB. High vaccine costs render this strategy economically unfeasible for older adults, pregnant women, and women of childbearing age."

HEOR • Journal • Hepatitis B • Infectious Disease • Inflammation

The effectiveness of two doses of Hecolin vaccine in response to outbreaks in resource-limited settings. (PubMed, Virol Sin) - No abstract available

Journal

Avian HEV triggered egg decline: Viral-host, immune-neuroendocrine mechanisms in layers. (PubMed, Vet Microbiol) - "We propose that antioxidant therapies, receptor-blocking strategies, and multi-epitope vaccines targeting conserved ORF2/ORF3 regions could mitigate aHEV's economic impact. Furthermore, unresolved questions regarding viral latency, transovarial transmission, and zoonotic risks necessitate integrated approaches combining organoid models, single-cell omics, and One Health surveillance to address this evolving challenge."

Journal • Review • Inflammation

Safety and immunogenicity of thiomersal-free recombinant hepatitis E vaccine: A randomized, double-blind, active-controlled study. (PubMed, Vaccine) - P4 | "The thiomersal-free hepatitis E vaccine demonstrated non-inferior immunogenicity compared with the licensed hepatitis E vaccine Hecolin® and showed an acceptable safety profile."

Clinical • Journal • Inflammation

Hepatitis E vaccine landscape update 2025. (PubMed, Expert Rev Vaccines) - "Ongoing trials in Pakistan and South Africa will offer key data on safety in pregnancy, immunogenicity in children, and use in people with HIV. WHO prequalification of HEV 239 vaccine is critical to expand access globally."

Journal • Review • Human Immunodeficiency Virus • Infectious Disease • Inflammation

Cellular and Humoral Immune Profiles After Hepatitis E Vaccination and Infection. (PubMed, Viruses) - "Longitudinal antibody assessments confirmed sustained antibody production, primarily against the E2 domain of genotypes 1 and 3, persisting up to two years post-vaccination. Despite limitations related to sample size and assay sensitivity, our findings underscore the immunogenic potential of HEV239 and support a broader use in HEV-endemic regions."

Journal • Infectious Disease • Inflammation • IFNG • IL4

Vaccination Strategies and Research Gaps in Hepatitis E Virus for Special Populations. (PubMed, Vaccines (Basel)) - "Addressing regulatory, economic, and logistical barriers remains crucial for effective HEV vaccination programs. A multidisciplinary approach integrating public health policy, rigorous clinical evaluations, and collaborative frameworks is essential to ensure equitable access to HEV vaccination, ultimately improving health outcomes on a global scale."

Journal • Review • Hepatology • Infectious Disease • Inflammation

Immunogenicity and Safety of Hecolin® in HIV Positive/Negative Adults and in Children (clinicaltrials.gov) - P2 | N=1040 | Recruiting | Sponsor: International Vaccine Institute | Not yet recruiting ➔ Recruiting

Enrollment open • Hepatology • Human Immunodeficiency Virus • Infectious Disease • Inflammation

High confidence and demand for hepatitis E vaccine during an outbreak in Bentiu, South Sudan: A qualitative study. (PubMed, PLOS Glob Public Health) - "Personal experiences with hepatitis E illness, perceived severity of illness, and confidence in organizations recommending the vaccine were drivers of high demand for hepatitis E vaccines in the first-ever use of the vaccine in an outbreak setting. Addressing practical issues related to population mobility can improve coverage in future campaigns."

Journal • Hepatology • Inflammation

Safety and immunogenicity of hepatitis E vaccine in compensated liver cirrhosis with chronic hepatitis B. (PubMed, Clin Microbiol Infect) - "This study suggests that Hecolin is safe and immunogenic in CHB patients with compensated liver cirrhosis, supporting its use in preventing HEV superinfection in this high-risk population."

Journal • Fibrosis • Gastroenterology • Hepatitis B • Hepatology • Immunology • Infectious Disease • Inflammation • Liver Cirrhosis

Effectiveness of a hepatitis E vaccine against medically-attended symptomatic infection in HBsAg-positive adults from a test-negative design study. (PubMed, Nat Commun) - P3 | "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)...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."

Journal • Hepatitis B • Hepatitis C • Hepatology • Infectious Disease • Inflammation

Immunogenicity and Efficacy of an Accelerated Vaccination Schedule Against Hepatitis E Virus Infection in Rabbits. (PubMed, J Med Virol) - "Our results suggest that an accelerated vaccination schedule (0 and 7 days) could provide protective antibodies in a shorter time. The accelerated schedule should be further recommended for use as a backup in FCV settings or during a hepatitis E outbreak."

Journal • Preclinical • Hepatology • Infectious Disease • Inflammation

Evaluating the Efficacy and Safety of Hepatitis E Vaccination in Reproductive-Age Women: A Systematic Review and Meta-Analysis. (PubMed, Vaccines (Basel)) - "HEV239 is effective in preventing HEV infection among women of childbearing age, although caution is advised when administering the vaccine near conception due to potential miscarriage risks. Future studies should focus on understanding the biological mechanisms and timing-specific safety to guide vaccination recommendations."

Journal • Retrospective data • Review • Hepatology • Infectious Disease • Inflammation

Immunogenicity, Efficacy, and Effectiveness of Two-Dose and Shorter Schedules of Hepatitis E Vaccine: A Systematic Review. (PubMed, Vaccines (Basel)) - "Administration of two doses was also associated with a high protective efficacy against HEV infection and associated disease. The available data indicate that two doses of HEV 239 administered one month apart confer sufficiently high antibody titers and protection for at least 13 months, a duration which should be adequate for its use as an outbreak control measure."

Journal • Review • Hepatology • Infectious Disease • Inflammation

The effectiveness of two doses of recombinant hepatitis E vaccine in response to an outbreak in Bentiu, South Sudan: a case-control and bias indicator study. (PubMed, Lancet Infect Dis) - "Despite the small sample size, our estimates provide evidence of effectiveness of a two-dose regimen against HEV genotype 1 during a protracted outbreak, supporting its use in similar contexts."

Journal • Hepatology • Infectious Disease • Inflammation

Hecolin vaccination strategies for hepatitis E outbreak control in resource-constrained settings. (PubMed, Lancet Infect Dis) - No abstract available

Journal • Hepatology • Inflammation

Immunogenicity and safety of HepE Hecolin® in chronic hepatitis B patients at clinically stable stage: An open-label study in China. (PubMed, Hum Vaccin Immunother) - "Changes in the liver function indicators were not of clinical significance. The HepE was highly immunogenic and well tolerated among clinically stable CHB patients and healthy adults."

Journal • Hepatitis B • Hepatology • Infectious Disease • Inflammation

Persistence of hepatitis E vaccine-induced antibody response across different dosage schedules and baseline serostatus. (PubMed, NPJ Vaccines) - P3 | "After a single dose, individuals with pre-existing immunity achieved high and sustained antibody levels for over 103 months, comparable to the two-dose regimen. Both single-dose and two-dose HEV239 regimens demonstrated notable immunogenicity and persistence, potentially offering substantial protective benefits."

Journal • Hepatology • Infectious Disease • Inflammation

Cell binding tropism of rat hepatitis E virus is a pivotal determinant of its zoonotic transmission to humans. (PubMed, Proc Natl Acad Sci U S A) - "In summary, the interactions between the viral capsid and cellular receptor(s) regulate the distinct zoonotic potentials of different HEV species. The systematic characterization of antigenic cartography and serological cross-reactivity of different HEV species provide valuable insights for the development of species-specific diagnosis and protective vaccines against zoonotic HEV infection."

Journal • Preclinical • Hepatology • Infectious Disease • Inflammation