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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
120
one dose, Low 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.
placebo, one doses
placebo, two doses, with one dose to each arm at a same time.
Phase 1 vaccine clinical trial center of Jiangsu Provincial Center for Disease Control and Prevention
Taizhou, Jiangsu, China
Occurrence of adverse reactions after vaccination.
Occurrence of adverse reactions within 7 days after vaccination with the Ebola Zaire vaccine (Ad5-EBOV).
Time frame: within 7 days after the vaccination
Specific anti-EBOV antibody responses to the Ebola Zaire vaccine (Ad5-EBOV).
Specific anti-EBOV antibody responses to the Ebola Zaire vaccine (Ad5-EBOV) as measured by ELISA.
Time frame: 28 days after the vaccination
Specific T cell immune responses to the Ebola Zaire vaccine (Ad5-EBOV).
Specific T cell immune responses to the Ebola Zaire vaccine (Ad5-EBOV) as measured by intracellular cytokine staining assays (ICS)
Time frame: 28 days after the vaccination
Occurrence of adverse events after the vaccination.
Occurrence of adverse events within 28 days after vaccination with the Ebola Zaire vaccine (Ad5-EBOV).
Time frame: within 28 days after the vaccination
Changes of the laboratory examinations after vaccination.
Changes of the laboratory examinations after vaccination with the Ebola Zaire vaccine (Ad5-EBOV) on day 3, 14 and 28.
Time frame: day 0-28 after the vaccination
Occurrence of serious adverse events after the vaccination.
Occurrence of serious adverse events within 6 months after the vaccination with the Ebola Zaire vaccine (Ad5-EBOV).
Time frame: within 6 months after the vaccination
Specific anti-EBOV antibody responses to the Ebola Zaire vaccine (Ad5-EBOV).
Specific anti-EBOV antibody responses to the Ebola Zaire vaccine (Ad5-EBOV) at day 168 as measured by ELISA.
Time frame: 168 days after the vaccination
Specific T cell immune responses to the Ebola Zaire vaccine (Ad5-EBOV).
Specific T cell immune responses to the Ebola Zaire vaccine (Ad5-EBOV) at day 168 as measured by intracellular cytokine staining assays (ICS).
Time frame: 168 days after the vaccination
Anti-adenovirus neutralizing antibody responses to the Ebola Zaire vaccine (Ad5-EBOV).
Anti-adenovirus neutralizing antibody responses to the Ebola Zaire vaccine (Ad5-EBOV) at day 168.
Time frame: 168 days after the vaccination
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