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The purpose of the study is to determine the safety and tolerability of ND1.1, an adjuvanted adenoviral-based avian influenza vaccine, when delivery is targeted to the ileum, using a radio controlled capsule. The secondary objective is to evaluate the immune response (cellular and humoral) of two doses of ND1.1 oral vaccine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intestinal Delivery | Experimental | ND1.1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ND1.1 | Biological |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety | Frequency and magnitude of adverse events | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity | Antibody and T cell responses to HA | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Liebowitz, MD, PhD | Vaxart, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scintipharma | Lexington | Kentucky | United States |
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| ID | Term |
|---|---|
| D005585 | Influenza in Birds |
| ID | Term |
|---|---|
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| D001715 |
| Bird Diseases |
| D000820 | Animal Diseases |