Last reviewed · How we verify
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
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.
Details
| Lead sponsor | Jiangsu Province Centers for Disease Control and Prevention |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 120 |
| Start date | 2014-12 |
| Completion | 2015-07 |
Conditions
- Ebola Virus Disease
Interventions
- Low dose Ebola Zaire vaccine (Ad5-EBOV)
- High dose Ebola Zaire vaccine (Ad5-EBOV)
- placebo (one dose)
- placebo (two doses)
Primary outcomes
- Occurrence of adverse reactions after vaccination. — 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). — 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). — 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)
Countries
China