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A study to evaluate the immune response and safety of AdCOVID administered as an intranasal spray in healthy adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Low Dose AdCOVID | Experimental |
| |
| Single Medium Dose AdCOVID | Experimental |
| |
| Single High Dose AdCOVID | Experimental |
| |
| Two Low Doses AdCOVID | Experimental |
| |
| Two Medium Doses AdCOVID | Experimental |
| |
| Two High Doses AdCOVID | Experimental |
| |
| Single Dose Placebo | Placebo Comparator |
| |
| Two Dose Placebo |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AdCOVID | Biological | Administered intranasally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reactogenicity | Counts and percentages of subjects with local and systemic events | For 7 days after vaccination |
| Adverse Events (AEs) | Counts and percentages of subjects with AEs | Day 1 to Day 57 |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-SARS-CoV-2 spike IgG antibody levels | Day 1 to Day 366 | |
| Neutralizing antibody titer against live and/or pseudotyped SARS-CoV-2 virus | Day 1 to Day 366 |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-SARS-CoV-2 RBD T cell responses by interferon (IFN)-gamma enzyme-linked immunosorbent spot (ELISpot) | Day 1 to Day 366 | |
| Mucosal antibody responses in nasopharyngeal swabs (anti-SARS-CoV-2 spike IgA titers) | Day 1 to Day 366 |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AGA Clinical Trials | Hialeah | Florida | 33012 | United States | ||
| Optimal Research |
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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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|
| Placebo | Other | Administered intranasally |
|
| Melbourne |
| Florida |
| 32934 |
| United States |
| Optimal Research | Peoria | Illinois | 61614 | United States |
| Optimal Research | Rockville | Maryland | 20850 | United States |
| Optimal Research | Austin | Texas | 78705 | United States |
| Clinical Trials of Texas | San Antonio | Texas | 78229 | United States |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |