A Safety and Immunogenicity of Intranasal Nanoemulsion Adjuvanted Recombinant Anthrax Vaccine in Healthy Adults

Summary

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.

Timeline

Start

2020-01-08

Primary completion

2021-09-02

Completion

2021-09-02

Drugs

Indications