NCT02326194

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

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 Healthy Adults in China

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Jiangsu Province Centers for Disease Control and Prevention · Network
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ebola Virus Disease

Interventions

Type	Name	Description
BIOLOGICAL	Low dose Ebola Zaire vaccine (Ad5-EBOV)	one dose, Low dose Ebola Zaire vaccine (Ad5-EBOV)
BIOLOGICAL	High dose Ebola Zaire vaccine (Ad5-EBOV)	two doses, High dose Ebola Zaire vaccine (Ad5-EBOV), with one dose to each arm at a same time.
BIOLOGICAL	placebo (one dose)	placebo, one doses
BIOLOGICAL	placebo (two doses)	placebo, two doses, with one dose to each arm at a same time.

Timeline

• Start date: 2014-12-01
• Primary completion: 2015-02-01
• Completion: 2015-07-01
• First posted: 2014-12-25
• Last updated: 2015-08-28

Locations

1 site across 1 country: China