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The purpose of this study is to test the safety and immune response of a new intranasal vaccine against influenza, called NB-1008. The vaccine is composed of a licensed vaccine that is normally given as an injection, called Fluzone, and an adjuvant (additive that helps a vaccine work better), called W805EC. In a prior clinical study this vaccine showed promising results in terms of being well tolerated and eliciting mucosal and systemic immune responses after administration by a dropper. In this study NB-1008 is being administered by dropper as well as a nasal sprayer to determine if the sprayer further enhances the immune response.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluzone 15 mcg HA 200 mcl IN by Pipette | Active Comparator |
| |
| NB-1008 15 mcg HA 20% W805EC 200 mcl IN by Pipette | Experimental |
| |
| Fluzone 15 mcg HA 200 mcl IN by Nasal Spray | Active Comparator |
| |
| NB-1008 15 mcg HA 20% W805EC 200 mcl IN by Nasal Spray | Experimental |
| |
| NB-1008 15 mcg HA 20% W805EC 400 mcl IN by Nasal Spray | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NB-1008 | Biological | NB-1008 is composed of Fluzone containing 15 micrograms (mcg) of strain-specific hemagglutinin (HA) and 20% W805EC adjuvant. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability | Number of Participants with Adverse Events (AE) collected through Day 28 and Serious Adverse Events (SAE) collected through Day 365. | 365 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Systemic Humoral Immune Response | Serum hemagglutination-inhibition (HAI) Geometric Mean Titer (GMT) and proportion of Volunteers with >=4 fold increase in titer as well as proportion of volunteers with titer >= protective level of 40 | Day 28 and Day 60 |
| Systemic Cell Mediated Immune Response |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Casey T Johnson, DO | Johnson County Clin-Trials | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johnson County Clin-Trials | Lenexa | Kansas | 66219 | United States |
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| ID | Term |
|---|---|
| D007252 | Influenza Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| Fluzone IN | Biological | The active control is Fluzone containing 15 micrograms (mcg) of strain-specific hemagglutinin (HA). |
|
Stimulation Index (SI) of antigen-specific proliferation and cytokine secretion of peripheral mononuclear cells (PBMC) |
| Day 28 |
| Mucosal Immune Response | Nasal wash anti-Fluzone IgA Geometric Mean Titer (GMT) and proportion of volunteers with >=4 fold increase in GMT anti-Fluuzone IgA titer | Day 14 and Day 28 |