NCT02603055

A Clinical Trial to Evaluate a Recombinant Hepatitis E Vaccine in Healthy Adults

A Phase Ib Single Center, Randomized, Blinding, Parallel-controlled Clinical Trial to Evaluate the Safety and Immunogenicity of a Recombinant Hepatitis E Vaccine in Healthy Adults Aged 16 to 65 Years Old in China

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Jiangsu Province Centers for Disease Control and Prevention · Network
• Sex: All
• Age: 16 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Hepatitis E is characteristic by sporadic and local epidemic around the world, and mainly infects adults aged 15 to 40 years old, resulting in the infection rate ranged from 1% to 15%. The investigational hepatitis E vaccine is a recombinant aluminium-adjuvant hepatitis E vaccine. This is a single center, randomized, blinding, parallel-controlled phase Ib clinical trial. This study will determine the safety and immunogenicity of the investigational recombinant hepatitis E vaccine in healthy adults between 16 and 65 years.

Conditions

• Hepatitis E

Interventions

Type	Name	Description
BIOLOGICAL	30μg/0.5ml Hepatitis E vaccine	three doses, 30μg/0.5ml per dose
BIOLOGICAL	30μg/0.5ml Recombinant Hepatitis E vaccine	30μg/0.5ml Hepatitis E vaccine developed by Xiamen innovax biotech Co.,Ltd.,three doses, 30μg/0.5ml per dose

Timeline

• Start date: 2015-07-01
• Primary completion: 2016-04-01
• Completion: 2016-08-01
• First posted: 2015-11-11
• Last updated: 2016-09-01

Locations

1 site across 1 country: China