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| Name | Class |
|---|---|
| Zhongnan Hospital | OTHER |
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This is a clinical trial to evaluate the safety and immunogenicity of a recombinant adenovirus 5 vectored COVID-19 vaccine (Ad5-nCoV) with two doses and with different adminstration routes in healthy adults aged 18 years and older.
A total of 168 healthy adult volunteers will be vaccinated in this clinical trial according to open, partly randomized design from the healthy adults aged 18 years and older. The safety and immunogenicity of intramuscular vaccination and mucosal vaccination of two doses of Ad5-nCoV in different administration schedules will be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: Intramuscular administration | Experimental | 24 subjects. 5E10 VP of Ad5-nCoV on Day 0 and on Day 56. |
|
| Group B: Mixed administration | Experimental | 24 subjects. An intramuscular administration of 5E10 VP of Ad5-nCoV on day 0 and a mucosal administration of 2E10 VP on Day 28. |
|
| Group C: Mucosal administration, high dose | Experimental | 24 subjects. A mucosal administration of 2E10 VP of Ad5-nCoV on Day 0 and Day 28. |
|
| Group D: Mucosal administration, low dose | Experimental | 24 subjects. A mucosal administration of 1E10 VP of Ad5-nCoV on day 0 and Day 28. |
|
| Group E: Intramuscular administration, one dose | Active Comparator | 24 subjects. An intramuscular administration of 5E10 VP of Ad5-nCoV on day 0. |
|
| Group F: Intramuscular administration, two doses |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ad5-nCoV | Biological | Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of the AE in all groups | The occurrence of AE in all groups within 0-7 days after each vaccination; | 0-7 days after each vaccination |
| Seroconversion rate of the IgG antibody against SARS-CoV-2 | Seroconversion rate the IgG antibody against SARS-CoV-2 measured on Day 28 after last vaccination | Day 28 after last vaccination |
| Geomean titers of the IgG antibody against SARS-CoV-2 | Geomean titers of the IgG antibody against SARS-CoV-2 measured on Day 28 after last vaccination | Day 28 after last vaccination |
| Seroconversion rate of the neutralizing antibody against SARS-CoV-2 | Seroconversion rate of the neutralizing antibody against SARS-CoV-2 measured on Day 28 after last vaccination | Day 28 after last vaccination |
| Geomean titers of the neutralizing antibody against SARS-CoV-2 | Geomean titers of the neutralizing antibody against SARS-CoV-2 measured on Day 28 after last vaccination | Day 28 after last vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of the AE in all groups | The occurrence of AE in all groups within 0-30 minutes and 0-28 days after each vaccination. | 0-30 minutes, 0-28 days after each vaccination |
| Incidence of Serious adverse events (SAE) in all groups |
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Inclusion Criteria:
Exclusion Criteria for the first vaccination:
Exclusion Criteria for the second vaccination:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongnan Hospital | Wuhan | Hubei | 430071 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34324836 | Derived | Wu S, Huang J, Zhang Z, Wu J, Zhang J, Hu H, Zhu T, Zhang J, Luo L, Fan P, Wang B, Chen C, Chen Y, Song X, Wang Y, Si W, Sun T, Wang X, Hou L, Chen W. Safety, tolerability, and immunogenicity of an aerosolised adenovirus type-5 vector-based COVID-19 vaccine (Ad5-nCoV) in adults: preliminary report of an open-label and randomised phase 1 clinical trial. Lancet Infect Dis. 2021 Dec;21(12):1654-1664. doi: 10.1016/S1473-3099(21)00396-0. Epub 2021 Jul 26. |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C000706167 | Ad5-nCoV vaccine |
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| Experimental |
24 subjects. Two intramuscular administrations of 5E10 VP of Ad5-nCoV at left and right arms on day 0. |
|
The occurrence of Serious adverse events (SAE) in all groups within 6 months after the final vaccination.
| 6 months after the final vaccination |
| Geomean titers of the IgG antibody against SARS-CoV-2 | Geomean titers of the IgG antibody against SARS-CoV-2 measured on Day 0, 14, 28 and 56 after first vaccination and on Day 14 and Day168 after last vaccination. | Day 0, 14, 28 and 56 after first vaccination and Day 14 and Day168 after last vaccination. |
| Seroconversion rate of the IgG antibody against SARS-CoV-2 | Seroconversion rate of the IgG antibody against SARS-CoV-2 measured on Day 0, 14, 28 and 56 after first vaccination and on Day 14 and Day168 after last vaccination. | Day 0, 14, 28 and 56 after first vaccination and Day 14 and Day168 after last vaccination. |
| Geomean titers of the neutralizing antibody against SARS-CoV-2 | Geomean titers of the neutralizing antibody against SARS-CoV-2 measured on Day 0, 14, 28 and 56 after first vaccination and on Day 14 and Day168 after last vaccination. | Day 0, 14, 28 and 56 after first vaccination and Day 14 and Day168 after last vaccination. |
| Seroconversion rate of the neutralizing antibody against SARS-CoV-2 | Seroconversion rate of the neutralizing antibody against SARS-CoV-2 measured on Day 0, Day14, Day 28 or Day 56 after first vaccination and on day 14, day 28 and day168 after last vaccination. | Day 0, 14, 28 and 56 after first vaccination and on Day 14 and Day168 after last vaccination. |
| Cellular immune response by ELISpot | The positive rate of IFN-γ stimulated by S protein overlapping peptide library detected by ELISpot on Day 0 and Day 14 after each vaccination | Day 0 and Day 14 after each vaccination |
| Geomean titers of neutralizing antibody response to Ad5-vector | Geomean titers of neutralizing antibody response to Ad5-vector on Day 0, 14 and 28 after each vaccination. | Day 0, 14 and 28 after each vaccination. |
| Cellular immune response by ICS | The positive rate of the specific cytokines expressed by CD4+ and CD8+ T lymphocytes stimulated by S protein overlapping peptide library detected by intracellular cytokine staining on Day 0 and Day 14 after each vaccination | Day 0 and Day 14 after each vaccination |
| Geomean titers of the IgA antibody against SARS-CoV-2 | Geomean titers of the IgA antibody against SARS-CoV-2 on Day 0, 14 and 28 after each vaccination. | Day 0, 14 and 28 after each vaccination |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |