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The purpose of this study was to demonstrate the safety and immunogenicity of an oral vaccine tablet to prevent seasonal influenza. The study was a placebo controlled, double blinded trial at a single site. The study was conducted under two separate protocols. Initially single administrations at two dose levels (low dose and mid dose) of the oral vaccine was tested in a placebo controlled study (37 subjects). And subsequently a single high dose of the oral vaccine was tested in a separate placebo-controlled study (24 subjects).
Low and mid dose study was conducted under protocol number VXA02-001
High dose study was conducted under protocol number VXA02-003
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Dose VXA-A1.1 Oral Vaccine | Experimental | Two doses of replication incompetent adenovirus vaccine given in an oral tablet formulation. |
|
| VXA Placebo Tablet | Placebo Comparator | Oral tablets of the same size and number as the vaccine tablet doses. Placebo arms were included during enrollment of each of the experimental dose groups to maintain the double-blind study design. |
|
| Medium Dose VXA-A1.1 Oral Vaccine | Experimental | Two doses of replication incompetent adenovirus vaccine given in an oral tablet |
|
| High Dose VXA-A1.1 Oral Vaccine | Experimental | One dose of replication incompetent adenovirus given in an oral tablet dose. This dose was studied under protocol VXA02-003. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VXA-A1.1 Oral Vaccine | Biological | One or two doses of replication incompetent adenovirus oral tablet vaccine |
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| Measure | Description | Time Frame |
|---|---|---|
| Safety of an oral vaccine tablet as measured by reported solicited (reactogenicity) and unsolicited adverse events | One year following last vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Magnitude of humoral immune response to influenza as measured by functional assays | 28 Days and 180 Days post-vaccination | |
| Magnitude of cellular immune responses to influenza as measured by functional assays | 28 Days and 180 Days post-vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Liebowitz, MD, PhD | Vaxart, Inc. | Study Director |
| Apinya Vutikullird, DO | WCCT | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| WCCT | Cypress | California | 90630 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26333337 | Result | Liebowitz D, Lindbloom JD, Brandl JR, Garg SJ, Tucker SN. High titre neutralising antibodies to influenza after oral tablet immunisation: a phase 1, randomised, placebo-controlled trial. Lancet Infect Dis. 2015 Sep;15(9):1041-1048. doi: 10.1016/S1473-3099(15)00266-2. |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| VXA Placebo Tablet | Biological | Off-white tablets similarly formulated to the active drug product tablets. |
|
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| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |