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Clinical Trials associated with BW-1010A Phase 1 Randomized, Observer-Blind, Active- and Placebo-Controlled Dose Comparison, Safety, Tolerability and Immunogenicity Study of Intranasal Adjuvanted Anthrax Vaccine (BW-1010; rPA + 20%W805EC) in Healthy Adult Volunteers Administered by Nasal Sprayer and Pipette With an Additional Unblinded Positive Control Arm
The purpose of this clinical trial is to evaluate the safety and immunogenicity of BW-1010.
BW-1010 is a nanoemulsion adjuvanted recombinant protein (rPA) that would protect against fatal outcome resulting from exposure to anthrax.
The vaccine will be administered intranasally (IN) to healthy adults, age 18 - 49.
The study will be conducted in 84 volunteers in one center in the United States.
The study will compare 2 different dose levels of rPA (50µg and 100µg rPA), and 2 different administration methods (a sprayer and dropper) with a negative control (saline) and a positive control (the injectable BioThrax licensed vaccine).
The vaccines and negative controls will be administered in 2 IN doses (4 weeks apart). The positive control will be 3 subcutaneous doses, 2 weeks apart. All volunteers will be observed for 1 year after the last dose.
Immunological outcome studied will be from the serum, blood cells and nasal washes.
100 Clinical Results associated with BW-1010
100 Translational Medicine associated with BW-1010
100 Patents (Medical) associated with BW-1010
100 Deals associated with BW-1010