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The trial will enroll up to 57 subjects. Qualified normal healthy volunteers will be enrolled in the study to receive the vaccine or placebo vaccine. Subjects will receive 2 vaccinations with a needle and will be followed for 6 months to evaluate the safety of and the immune system's response to the vaccine. The safety and immune system response will be studied throughout the trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2 | Experimental |
| |
| 3 | Experimental |
| |
| 4 | Experimental |
| |
| 5 | Placebo Comparator |
| |
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VCL-IPT1 | Biological | IM, 0.1 mg/mL, 2 injections, 0 and 21 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability of VCL-IPT1 and VCL-IPM1 in adult subjects | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Influenza-specific immunogenicity of VCL-IPT1 and VCL-IPM1 | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Don Guterwill, BS, MT | Vical | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Accelovance | San Diego | California | 92108 | United States | ||
| SNBL |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| D005585 | Influenza in Birds |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| VCL-IPT1 |
| Biological |
IM, 0.5 mg/mL, 2 injections, 0 and 21 days |
|
| VCL-IPT1 | Biological | IM, 1 mg/mL, 2 injections, 0 and 21 days |
|
| VCL-IPM1 | Biological | IM, 1 mg/mL, 2 injections, 0 and 21 days |
|
| PBS | Biological | IM, 1 mL, 2 injections, 0 and 21 days |
|
|
| Baltimore |
| Maryland |
| 21201 |
| United States |
| SUNY at Stonybrook, Stony Brook Medical Center | Stony Brook | New York | 11794-8153 | United States |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| D001715 | Bird Diseases |
| D000820 | Animal Diseases |