NCT05976594

Long-term Effectiveness of a Recombinant Hepatitis E Vaccine

Long-term Effectiveness of a Recombinant Hepatitis E Vaccine: a Test-negative Design Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 2,900 (estimated)
• Sponsor: Xiamen University · Academic / Other
• Sex: All
• Age: 32 Years – 82 Years
• Healthy volunteers: Not accepted

Summary

This test-negative study is designed to evaluate the long-term effectiveness of hepatitis E vaccine (Hecolin®) and to explore the prevalence of rat hepatitis E in Dongtai City.

Detailed description

In this negative test study, residual clinical serum will be collected from 13 hospitals in Dongtai, if it was from patients born between 1941-1991 from 11 towns in Dongtai, who tested positive for ALT levels higher than 2.5 times the upper limit of normal (ULN). Detection of HEV IgM, IgG, antigen, RNA will be performed to diagnose hepatitis E (HE) in each individual. In addition, HE vaccination history will be collect. All the information above will be used to evaluate the long-term effectiveness of HE vaccine. Based on the study design, virological and serological detection (IgM, IgG, antigen, and RNA) of hepatitis E virus species C (HEV-C) will be performed to analyze the prevalence of rat hepatitis E infection in Dongtai.

Conditions

• Hepatitis E

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	serology and virology detection of hepatitis E virus	Serum will be tested for HEV serology and virology, including HEV-IgM, HEV-IgG, HEV-antigen, and HEV-RNA for HEV species A (HEV-A) and HEV species C (HEV-C)，and further HEV genotyping for those positive for HEV-RNA.

Timeline

• Start date: 2023-08-12
• Primary completion: 2025-07-01
• Completion: 2025-07-01
• First posted: 2023-08-04
• Last updated: 2023-08-15

Locations

1 site across 1 country: China