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| Name | Class |
|---|---|
| Beijing Institute of Bioengineering, Academy of Military Medical Sciences | UNKNOWN |
| Tianjin Cansino Biotechnology Inc | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| low dose | Experimental | 30 participants will be firstly recruited and assigned to receive the low dose of Recombinant Human Type 5 Adenovirus Vector Based Ebola Vaccine (Ad5-EBOV). |
|
| High dose | Experimental | After the safety of the low dose vaccination is confirmed, another 30 participants will be recruited and assigned to receive the high dose of Recombinant Human Type 5 Adenovirus Vector Based Ebola Vaccine (Ad5-EBOV). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ad5-EBOV | Biological | intramuscular injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From March to July, 2015 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lanjuan Li | First Affiliated Hospital of Zhejiang University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First affiliated hospital of Zhejiang University | Hangzhou | Zhejiang | 310003 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28708962 | Derived | Wu L, Zhang Z, Gao H, Li Y, Hou L, Yao H, Wu S, Liu J, Wang L, Zhai Y, Ou H, Lin M, Wu X, Liu J, Lang G, Xin Q, Wu G, Luo L, Liu P, Shentu J, Wu N, Sheng J, Qiu Y, Chen W, Li L. Open-label phase I clinical trial of Ad5-EBOV in Africans in China. Hum Vaccin Immunother. 2017 Sep 2;13(9):2078-2085. doi: 10.1080/21645515.2017.1342021. Epub 2017 Jul 14. |
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| ID | Term |
|---|---|
| D019142 | Hemorrhagic Fever, Ebola |
| ID | Term |
|---|---|
| D006482 | Hemorrhagic Fevers, Viral |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| D018702 |
| Filoviridae Infections |
| D018701 | Mononegavirales Infections |