Nanoemulsion Adjuvanted Recombinant Pandemic Flu Vaccine(BlueWillow Biologics, Inc.)

The purpose of this clinical trial is to evaluate the safety and immunogenicity of BW-1014.
BW-1014 is a nanoemulsion (NE) adjuvanted recombinant Hemagglutinin 5 (rH5) that would protect against pandemic flu.
The study will be conducted in 40 healthy adults volunteers, age 18 - 45, in one center in the United States.
The study will compare 3 different dose levels of rH5 (25µg, 50µg and 100µg rH5 in 20% NE adjuvant using a pipette dropper with rH5 control (100µg without NE adjuvant) and placebo control (saline). The investigational product will be administered in 2 doses intranasally (IN). This will be followed 6 months later with a licensed H5N1 IIV IM vaccine.
In addition to safety outcome, homologous and heterologous immunological outcomes will be tested in nasal wash, serum, and blood cells.