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

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

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

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

Safety of hepatitis E vaccine in pregnancy: an emulated target trial following a mass reactive vaccination campaign in Bentiu internally displaced persons camp, South Sudan. (PubMed, Lancet Glob Health) - "No evidence of increased risk of fetal loss was found among individuals vaccinated during pregnancy."

Journal • Hepatology • Inflammation

Raising the case of hepatitis E: Report from the 2nd international HEV symposium. (PubMed, Vaccine) - "The conference highlighted presentations on several critical HEV vaccine studies that will greatly impact the field, including the largest effectiveness study of Hecolin vaccine outside of China and the first reactive mass-vaccination campaign in South Sudan. This report summarizes information shared at the convening and offers perspectives on the steps forward for hepatitis E."

Journal • Hepatology • Inflammation

Safety and Immunogenicity of Hecolin® in Healthy Pregnant Women (clinicaltrials.gov) - P2 | N=2358 | Recruiting | Sponsor: International Vaccine Institute | Not yet recruiting ➔ Recruiting

Enrollment open • Hepatology • Infectious Disease • Inflammation

Safety and Immunogenicity Study of Thiomersal-free Hepatitis E Vaccine in People Ages 16 Years and Above (clinicaltrials.gov) - P4 | N=612 | Completed | Sponsor: Xiamen Innovax Biotech Co., Ltd

New P4 trial • Hepatology • Inflammation

Progress and Challenges to Hepatitis E Vaccine Development and Deployment. (PubMed, Vaccines (Basel)) - "The only licensed hepatitis E vaccine worldwide, the HEV 239 (Hecolin) vaccine, has been demonstrated to be safe and efficacious in Phase III clinical trials, in which the efficacy of three doses of HEV 239 remained at 86.6% (95% confidence interval (CI): 73.0-94.1) at the end of 10 years follow-up. In this review, the progress and challenges for hepatitis E vaccines are summarized."

Journal • Review • Hepatitis C • Hepatology • Inflammation

Safety and effectiveness of a recombinant hepatitis E vaccine in women of childbearing age in rural Bangladesh: a phase 4, double-blind, cluster-randomised, controlled trial. (PubMed, Lancet Glob Health) - P4 | "The effectiveness of HEV239 in pregnant women remains uncertain. HEV239 was safe and well tolerated in non-pregnant women, but findings regarding miscarriage warrant further investigation."

Clinical • Journal • P4 data • Hepatitis B • Hepatology • Infectious Disease • Inflammation • Pain

Receipt of hepatitis E vaccine and fetal loss in rural Bangladesh: further analysis of a double-blind, cluster-randomised, controlled trial. (PubMed, Lancet Glob Health) - P4 | "HEV239 given shortly before or during pregnancy was associated with an elevated risk of miscarriage. This association poses a possible safety concern for programmatic use of HEV239 in women of childbearing age."

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

Immunisation of pigs with recombinant HEV vaccines does not protect from infection with HEV genotype 3. (PubMed, One Health) - "While Hecolin® only partial protected pigs from HEV shedding, the novel p239(gt3) vaccine was at least able to prevent infected pigs from virus shedding. The results highlight the need for further development of HEV vaccines that exhibit broad protection against multiple HEV genotypes and the use of appropriate animal infection models."

Journal • Hepatology • Infectious Disease • Inflammation

A Phase 1, Double-blinded, Placebo-Controlled Clinical Trial to Evaluate the Safety and Immunogenicity of HEV-239 (Hecolin®) Vaccine in Healthy US Adults. (PubMed, J Infect Dis) - P1 | "HEV-239 is safe and elicits a durable immune response through at least 6 months after the third dose in healthy US adults."

Clinical • Journal • P1 data • Hepatology • Inflammation

Immunogenicity and Safety of Hecolin® in HIV Positive/Negative Adults and in Children (clinicaltrials.gov) - P2 | N=860 | Not yet recruiting | Sponsor: International Vaccine Institute

New P2 trial • Hepatology • Human Immunodeficiency Virus • Infectious Disease • Inflammation