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The purpose of this study is to demonstrate the safety and immunogenicity of an oral vaccine to prevent avian influenza. Volunteers will receive either one or two doses of research vaccine or placebo as part of this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Low Dose | Experimental | Biological: One dose of a live replication incompetent adenovirus given in a capsule |
|
| Experimental Medium Dose | Experimental | Biological: One or two doses of replication incompetent adenovirus given in a capsule Other: Placebo capsules of the same size and shape |
|
| Experimental High Dose | Experimental | Biological: One dose of replication incompetent adenovirus in a capsule |
|
| Placebo Control | Placebo Comparator | Capsules of the same size and shape as the experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ND1.1 | Biological | adenovirus with the dsRNA adjuvant, dried and put into capsules |
|
| Measure | Description | Time Frame |
|---|---|---|
| Frequency or severity of vaccine related events as measured through reported AEs | up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Magnitude of humoral immune responses to avian influenza as measured by functional assays | up to 1 year | |
| Magnitude of cellular immune responses to avian influenza as measured by functional assays | up to 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sean N Tucker, PhD | Vaxart | Study Director |
| Martin Kabongo, MD, PhD | Accelovance | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Diego | California | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23357198 | Derived | Peters W, Brandl JR, Lindbloom JD, Martinez CJ, Scallan CD, Trager GR, Tingley DW, Kabongo ML, Tucker SN. Oral administration of an adenovirus vector encoding both an avian influenza A hemagglutinin and a TLR3 ligand induces antigen specific granzyme B and IFN-gamma T cell responses in humans. Vaccine. 2013 Mar 25;31(13):1752-8. doi: 10.1016/j.vaccine.2013.01.023. Epub 2013 Jan 25. |
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| ID | Term |
|---|---|
| D005585 | Influenza in Birds |
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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|
| Placebo control | Biological | Capsules of the same size and shape as experimental groups |
|
| D001715 |
| Bird Diseases |
| D000820 | Animal Diseases |
| D012141 | Respiratory Tract Infections |
| D012140 | Respiratory Tract Diseases |