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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase Ib Single Center, Randomized, Blinding, Parallel-controlled Clinical Trial to Evaluate the Safety and Immunogenicity of a Recombinant Hepatitis E Vaccine in Health

Brief 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.

Detailed Summary:
Sponsor: Jiangsu Province Centers for Disease Control and Prevention

Current Primary Outcome:

• Occurrence of adverse reactions after vaccination [ Time Frame: within 7 days after each vaccination ]
  Occurrence of adverse reactions within 7 days after each vaccination with the Recombinant Hepatitis E vaccine.
• The geometric mean concentration of antibody against Hepatitis E responses to the Hepatitis E vaccine [ Time Frame: 7 months after the first vaccination ]
  Antibody against Hepatitis E responses to the Hepatitis E vaccine at 7 months after the first vaccination

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Occurrence of adverse events after each vaccination [ Time Frame: within 28 days after each vaccination ]
  Occurrence of adverse events within 28 days after each vaccination with the Hepatitis E vaccine.
• Occurrence of serious adverse events after the vaccination. [ Time Frame: within 12 months after the first vaccination ]
  Occurrence of serious adverse events within 12 months after the first vaccination with the Hepatitis E vaccine.
• The positive rates of antibody against Hepatitis E responses to the Hepatitis E vaccine. [ Time Frame: 7 months after the first vaccination ]
  The positive rates of antibody against Hepatitis E responses to the Hepatitis E vaccine at 7 months after the first vaccination.

Original Secondary Outcome: Same as current

Information By: Jiangsu Province Centers for Disease Control and Prevention

Dates:
Date Received: November 10, 2015
Date Started: July 2015
Date Completion:
Last Updated: August 30, 2016
Last Verified: August 2016