Clinical Trial: A Phase I Clinical Trial to Evaluate the Ebola Adenovirus Vector Vaccine (Ad5-EBOV) in Healthy Adults.

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

Official Title: A Phase 1 Double-blind, Dose-escalation, Clinical Trial to Evaluate the Safety, Tolerability and Immunogenicity of the Ebola Adenovirus Vector Vaccine (Ad5-EBOV) in Health

Brief Summary:

Since its first outbreak occurred in 1976, Zaire Ebola virus have been associated with 14 outbreaks reported up to 2014. The Zaire Ebola virus in 2014 causing the most serious outbreak was considered to be a new epidemic strain, with GP homology of the gene was only 97.6%, compared to the GP gene of the strain in 1976. This investigational Ad5-EBOV vaccine was developed according to the 2014 epidemic Zaire strain and formulated as freeze-dry products which could be stored at 4℃.

This is a single center, double-blind, placebo control, dose-escalation phase 1 clinical trial. This study will determine the safety and side-effect profile, and immunogenicity of an investigational Ad5-EBOV vaccine.

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 the vaccination ]
  Occurrence of adverse reactions within 7 days after vaccination with the Ebola Zaire vaccine (Ad5-EBOV).
• Specific anti-EBOV antibody responses to the Ebola Zaire vaccine (Ad5-EBOV). [ Time Frame: 28 days after the vaccination ]
  Specific anti-EBOV antibody responses to the Ebola Zaire vaccine (Ad5-EBOV) as measured by ELISA.
• Specific T cell immune responses to the Ebola Zaire vaccine (Ad5-EBOV). [ Time Frame: 28 days after the vaccination ]
  Specific T cell immune responses to the Ebola Zaire vaccine (Ad5-EBOV) as measured by intracellular cytokine staining assays (ICS)

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Occurrence of adverse events after the vaccination. [ Time Frame: within 28 days after the vaccination ]
  Occurrence of adverse events within 28 days after vaccination with the Ebola Zaire vaccine (Ad5-EBOV).
• Changes of the laboratory examinations after vaccination. [ Time Frame: day 0-28 after the vaccination ]
  Changes of the laboratory examinations after vaccination with the Ebola Zaire vaccine (Ad5-EBOV) on day 3, 14 and 28.
• Occurrence of serious adverse events after the vaccination. [ Time Frame: within 6 months after the vaccination ]
  Occurrence of serious adverse events within 6 months after the vaccination with the Ebola Zaire vaccine (Ad5-EBOV).
• Specific anti-EBOV antibody responses to the Ebola Zaire vaccine (Ad5-EBOV). [ Time Frame: 168 days after the vaccination ]
  Specific anti-EBOV antibody responses to the Ebola Zaire vaccine (Ad5-EBOV) at day 168 as measured by ELISA.
• Specific T cell immune responses to the Ebola Zaire vaccine (Ad5-EBOV). [ Time Frame: 168 days after the vaccination ]
  Specific T cell immune responses to the Ebola Zaire vaccine (Ad5-EBOV) at day 168 as measured by intracellular cytokine staining assays (ICS).
• Anti-adenovirus neutralizing antibody responses to the Ebola Zaire vaccine (Ad5-EBOV). [ Time Frame: 168 days after the vaccination ]
  Anti-adenovirus neutralizing antibody responses to the Ebola Zaire vaccine (Ad5-EBOV) at day 168.

Original Secondary Outcome: Same as current

Information By: Jiangsu Province Centers for Disease Control and Prevention

Dates:
Date Received: December 22, 2014
Date Started: December 2014
Date Completion:
Last Updated: August 27, 2015
Last Verified: August 2015