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| Name | Class |
|---|---|
| Beijing Institute of Biotechnology | OTHER |
| Tianjin Cansino Biotechnology Inc | INDUSTRY |
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A Single-Center, Randomized, Blind, Phase II Clinical Trial to Evaluate the Safety and Immunogenicity of the Adenovirus Type 5 Vector Based Ebola Virus Disease Vaccine (Ad5-EBOV) in Healthy Adults Aged Between 18 and 50 years in Sierra Leone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | (4×10^10vp/vial, 4 vials): 1 ml sterilization injection water per dose to dilute 2 vials (4×10^10 vp/vial), one shot in each arm, total dose of 1.6×10^11vp. The inoculation site was the central lateral deltoid in the upper arm, and inoculation route was intramuscular injection |
|
| Group B | Experimental | (4×10^10vp/vial, 2 vials): 1 ml sterilization injection water per dose to dilute 1 vial (4×10^10vp/vial), total dose of 8×10^10vp, one shot in each arm. The inoculation site was the central lateral deltoid in the upper arm, and inoculation route was intramuscular injection |
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| Group C | Placebo Comparator | (0 vp/ vial, 2 vials):1 ml sterilization injection water per dose to dilute 1 vial, total dose of 0 vp. The inoculation site was the central lateral deltoid in the upper arm, and inoculation route was intramuscular injection |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ebola Vaccine | Biological |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of solicited adverse reactions after vaccination | 7 days after vaccination | |
| ELISA antigen-specific assays for antibody to GP responses | 14 days after vaccination | |
| ELISA antigen-specific assays for antibody to GP responses | 28 days after vaccination | |
| ELISA antigen-specific assays for antibody to GP responses | 168 days after vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of unsolicited adverse reactions after vaccination | 28 days after vaccination | |
| Occurrence of serious adverse reaction during the whole follow-up period | 6 months | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alie H Wurie | Ministry of Health & Sanitation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Alie H Wurie | Freetown | Sierra Leone |
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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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| ID | Term |
|---|---|
| D046129 | Ebola Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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control |
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| Post-vaccination Rate of infected with HIV |
| 6 months |
| Neutralizing antibody titers response to human Ad5 | 14 days after vaccination |
| Neutralizing antibody titers response to human Ad5 | 28 days after vaccination |
| Neutralizing antibody titers response to human Ad5 | 168 days after vaccination |
| D018702 |
| Filoviridae Infections |
| D018701 | Mononegavirales Infections |