Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Beijing Institute of Biotechnology | OTHER |
| Tianjin Cansino Biotechnology Inc | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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℃.
In 2014, a single center, double-blind, placebo control, dose-escalation phase 1 clinical trial was performed in Taizhou, China. Our findings show that the Ad5-EBOV vaccine is safe and robustly immunogenic. One shot of the high dose vaccine could mount glycoprotein-specific humoral and T-cell response against Ebola virus in 14 days. The investigators intent to evaluate the safety and immunogenicity of a booster dose of the recombinant Ebola adenovirus vector vaccine (Ad5-EBOV) in healthy adults after primary immunization in this add in study. The investigators expect that the boosting immunization with a same vaccine for primary immunization is possible and could confer a longer-lived protection when needed.
The phase I trial has been unblind 28 days after the primary vaccination, but all the subjects are still kept blind as well as the laboratory staffs. Therefore, this booster vaccination trial will be conduct in single blind.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| low dose group | Experimental | 4×10^10vp/1ml Ebola Zaire vaccine (Ad5-EBOV) |
|
| high dose group | Experimental | 1.6×10^11vp/2ml Ebola Zaire vaccine (Ad5-EBOV) |
|
| placebo group | Placebo Comparator | placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 4×10^10vp/1ml Ebola Zaire vaccine (Ad5-EBOV) | Biological | one dose, 4×10^10vp/1ml per dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of adverse reactions after vaccination | Occurrence of adverse reactions within 7 days after vaccination with the Ebola Zaire vaccine (Ad5-EBOV) | within 7 days after the boosting |
| 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 | 28 days after the boosting |
| Specific T cell immune responses to the Ebola Zaire vaccine (Ad5-EBOV) | Specific T cell immune responses to the Ebola Zaire vaccine (Ad5-EBOV) | 28 days after the boosting |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of adverse events after the vaccination | Occurrence of adverse events within 28 days after vaccination with the Ebola Zaire vaccine (Ad5-EBOV) | within 28 days after the boosting |
| Occurrence of serious adverse events after the vaccination |
Not provided
Inclusion Criteria:
Exclusion Criteria:
New occurrence of any of the following situation after the primary vaccination:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Feng-Cai Zhu | Jiangsu Province Centers for Disease Control and Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phase 1 vaccine clinical trial center of Jiangsu Provincial Center for Disease Control and Prevention | Taizhou | Jiangsu | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28017642 | Derived | Li JX, Hou LH, Meng FY, Wu SP, Hu YM, Liang Q, Chu K, Zhang Z, Xu JJ, Tang R, Wang WJ, Liu P, Hu JL, Luo L, Jiang R, Zhu FC, Chen W. Immunity duration of a recombinant adenovirus type-5 vector-based Ebola vaccine and a homologous prime-boost immunisation in healthy adults in China: final report of a randomised, double-blind, placebo-controlled, phase 1 trial. Lancet Glob Health. 2017 Mar;5(3):e324-e334. doi: 10.1016/S2214-109X(16)30367-9. Epub 2016 Dec 23. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D019142 | Hemorrhagic Fever, Ebola |
| ID | Term |
|---|---|
| D006482 | Hemorrhagic Fevers, Viral |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 1.6×10^11vp/2ml Ebola Zaire vaccine (Ad5-EBOV) | Biological | two doses, 0.8×10^11vp/1ml per dose, with one dose to each arm at the same time |
|
| placebo | Biological |
|
Occurrence of serious adverse events within 28 days after the vaccination with the Ebola Zaire vaccine (Ad5-EBOV)
| within 28 days after the boosting |
| Serum neutralizing antibody against the Ad5-vector | Serum neutralizing antibody against the Ad5-vector 28 days after the boosting | 28 days after the boosting |
| D018702 |
| Filoviridae Infections |
| D018701 | Mononegavirales Infections |