Clinical Trial: A Phase I Trial to Evaluate Ad5-EBOV in Healthy Adult Africans in China.

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

Official Title: A Phase 1, Dose-escalation, Open Clinical Trial to Evaluate Safety, Tolerability and Immunogenicity of the Recombinant Human Type 5 Adenovirus Vector Based Ebola Vaccine (

Brief Summary: This is a single center, open, dose-escalation phase 1 clinical trial. This study will determine the safety and side-effect profile, and immunogenicity of an investigational Ad5-EBOV vaccine in Healthy Adult Africans aged between 18-60 years in China.

Detailed Summary:

This is a single center, open, dose-escalation clinical trial. According to the Chinese guidelines for vaccine clinical trial, the sample size of a phase 1 clinical trial should be at least 20. In this study, a total of 60 participants will be included.30 participants will be firstly recruited and assigned to receive the low dose Ad5-EBOV. After the safety of the low dose vaccination is confirmed, another 30 participants will be recruited and assigned to receive the high dose Ad5-EBOV.

The whole follow-up period for each participant will be 28 days.

Sponsor: First Affiliated Hospital of Zhejiang University

Current Primary Outcome: A Phase I, Open Clinical Trial to Evaluate the Adenovirus Type 5 Vector Based Ebola Virus Disease Vaccine (Ad5-EBOV) in Healthy Adult Africans in China. [ Time Frame: From March to July, 2015 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: First Affiliated Hospital of Zhejiang University

Dates:
Date Received: March 24, 2015
Date Started: March 2015
Date Completion:
Last Updated: July 15, 2015
Last Verified: July 2015