NCT06564116

Safety and Immunogenicity Study of Thiomersal-free Hepatitis E Vaccine in People Ages 16 Years and Above

A Randomized, Double-blind, Active Comparator Clinical Trial to Evaluate Safety and Immunogenicity of Thiomersal-free Recombinant Hepatitis E Vaccine (Escherichia Coli) in People Ages 16 Years and Above

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 612 (actual)
• Sponsor: Xiamen Innovax Biotech Co., Ltd · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety and non-inferior immunogenicity of thiomersal-free Recombinant Hepatitis E Vaccine (Escherichia Coli) compared with licensed Recombinant Hepatitis E Vaccine (Escherichia Coli) when administered in participants ages 16 years and above.

Detailed description

This is a single-center, randomized, double-blind, active-comparator study to evaluate the safety and immunogenicity of thiomersal-free Recombinant Hepatitis E Vaccine (Escherichia Coli) in participants ages 16 years and above. Sex (male, female) and age (16-40 years old, 41 years old and above) are used as stratified factors. Participants are randomly assigned in a 1:1 ratio to receive three doses of thiomersal-free hepatitis E vaccine or licensed hepatitis E vaccine intramuscularly at Month 0, 1 and 6. The vaccine safety is assessed from the 1st dose vaccination to 6 months after the last dose vaccination. Serum samples are collected for anti-HEV IgG determination at Month 0 and 7.

Conditions

• Hepatitis E

Interventions

Type	Name	Description
BIOLOGICAL	Thiomersal-free Recombinant Hepatitis E Vaccine (Escherichia Coli)	Participants would receive 3 doses of thiomersal-free hepatitis E vaccine intramuscularly at month 0, 1 and 6.
BIOLOGICAL	Recombinant Hepatitis E Vaccine (Escherichia Coli)	Participants would receive 3 doses of licensed hepatitis E vaccine intramuscularly at month 0, 1 and 6

Timeline

• Start date: 2023-03-22
• Primary completion: 2024-03-28
• Completion: 2024-03-28
• First posted: 2024-08-21
• Last updated: 2024-08-21

Locations

1 site across 1 country: China