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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phosphate Buffered Saline (PBS) IN | Placebo Comparator |
| |
| Fluzone 4 mcg HA IN | Active Comparator |
| |
| Fluzone 15 mcg HA IM | Active Comparator |
| |
| NB-1008 4 mcg HA 5% W805EC | Experimental |
| |
| NB-1008 4 mcg HA 10% W805EC | Experimental |
| |
| NB-1008 4 mcg HA 15% W805EC | Experimental |
| |
| NB-1008 4 mcg HA 20% W805EC | Experimental |
| |
| Fluzone 10 mcg HA IN |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NB-1008 | Biological | NB-1008 is composed of Fluzone containing 4 micrograms (mcg) or 10 micrograms of strain-specific hemagglutinin (HA) and 5%, 10%, 15%, or 20% W805EC adjuvant. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events | Adverse events (AE) collected through Day 28 and Serious Adverse Events (SAE) collected through Day 365. | 365 Days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | HAI antibody titers to H1N1, H3N2, and B influenza strains contained in the vaccine. | Day 28 and Day 60 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johnson County Clin-Trials | Lenexa | Kansas | 66219 | United States |
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| Active Comparator |
|
| NB-1008 10 mcg HA 5% W805EC | Experimental |
|
| NB-1008 10 mcg HA 10% W805EC | Experimental |
|
| NB-1008 10 mcg HA 15% W805EC | Experimental |
|
| NB-1008 10 mcg HA 20% W805EC | Experimental |
|
| Control | Other | The controls include PBS placebo control as well as Fluzone IN and IM active controls. |
|
| Nasal wash anti-Fluzone IgA Geometric Mean Titer (GMT) and proportion of volunteers with >=4 fold increase in GMT anti-Fluuzone IgA titer |
Nasal Wash IgA to Fluzone. |
| Day 28 and Day 60 |