Hecolin HEV Vaccination Shows Safety and Immunogenicity in Patients With CHB

Recent research published in Clinical Microbiology and Infection shows that Hecolin (HEV 239; Xiamen Innovax Biotech Co. Ltd.), a recombinant vaccine indicated for hepatitis E virus (HEV), demonstrated safety and immunogenicity in patients with chronic hepatitis B (CHB) with compensated liver cirrhosis. The authors noted their optimism of the vaccine in this high-risk patient population, as it can prevent HEV superinfection.¹

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HEV is a global health concern that can cause acute hepatitis with severe consequences, notably in individuals with chronic liver disease. HEV is a common cause of acute viral hepatitis, and genotypes 1 and 2 are transmitted through contaminated food and water, causing large outbreaks across Asia and Africa. Additionally, the global burden of hepatitis E is difficult to estimate because of poor clinical surveillance and laboratory testing; however, an estimate in 1 publication suggests that there were over 70,000 HEV-related (genotypes 1 and 2) deaths in 2005.^1,2

Previously, Hecolin has demonstrated its safety and immunogenicity in patients, including those with pre-existing liver cirrhosis. In addition to its 3-dose regimen, which showed benefits—100% protective efficacy against clinically apparent HEV infections—and favorable safety profiles across different clinical trials, a case-control study that evaluated patients aged 16 to 40 years with acute jaundice who were suspected to have HEV also determined that a 2-dose vaccine regimen was effective. In the primary analysis, the authors estimated there was an unadjusted 2-dose vaccine effectiveness of approximately 67.8% (95% CI –28.6 to 91.9), and this increased to 84.0% (95% CI –208.5 to 99.2) following the adjustment for potential confounders.²

Knowing the efficacy of Hecolin, the study investigators aimed to assess the safety and immunogenicity of the 3-dose vaccine regimen in individuals with compensated liver cirrhosis who have CHB. This study was conducted in Shenzhen City, China, from November 2019 to June 2022. Depending on their disease status, 162 adult patients were assigned into 1 of the following groups: untreated CHB (n = 50); CHB treatment (n = 50); CHB cirrhosis (n = 43); and control (n = 19). The study’s safety assessment included adverse events (AEs) and liver function tests. Additionally, serological samples were collected from participants prior to Hecolin vaccination, and again 1 month following the first and third doses of vaccination to assess anti-HEV immunoglobulin G (IgG) antibodies.¹

Among the 162 participants, 157 (96.9%) received 3 doses of the Hecolin vaccine. The safety analysis revealed that 7-day local AEs were observed in approximately 14.0% of patients with CHB cirrhosis, 24.0% of those with treated CHB, 12.0% of those with untreated CHB, and 5.26% of controls. Additionally, systemic AEs were observed in 6.98%, 12.0%, 4.0%, and 0% of patients in these respective groups. No serious AEs were believed to be casually related to Hecolin vaccination, according to the investigators.¹

Further, in the per-protocol set for immunogenicity, all participants with cirrhosis (95% CI: 88.1-100%) who were vaccinated were seroconverted, and 82.8% (n = 24) had anti-HEV IgG levels that were higher than 1.0 WU/ml at the 1-month period following the final dose (median: 38 days; IQR: 31-44). The investigators emphasized that these data support the use of Hecolin in patients with CHB to prevent HEV superinfection, which can be significant for this high-risk population; however, further research is needed to strengthen and confirm the findings.¹

REFERENCES

1. Liao X, Li D, Su Y, et al. Safety and immunogenicity of hepatitis E vaccine in compensated liver cirrhosis with chronic hepatitis B. Clin Microbiol Infect. Published online February 28, 2025. doi:10.1016/j.cmi.2025.02.027

2. McGovern G. Two-Dose Hepatitis E Virus Vaccination Regimen Demonstrates Efficacy, Study Finds. Pharmacy Times. January 22, 2025. Accessed March 18, 2025. https://www.pharmacytimes.com/view/two-dose-hepatitis-e-virus-vaccination-regimen-demonstrates-efficacy-study-finds