Clinical Trial

Anthrax Vaccine

Study Description

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

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 (50A?g and 100A?g 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.

Location

Locations Selected Location

Methods

No pharmaceutical medication involved No pharmaceutical medication involved
Patients and healthy individuals accepted Patients and healthy individuals accepted

Biological - BW-1010: 50 µg - sprayer - IN

20% Nanoemulsion and 50 µg recombinant protective antigen administered intranasally by Aptar Bidose Sprayer (400µL). Two doses administered 4 weeks apart.

Biological - BW-1010: 50 µg - pipette - IN

20% Nanoemulsion and 50 µg recombinant protective antigen administered intranasally by pipette (400µL). Two doses administered 4 weeks apart.

Biological - BW-1010: 100 µg - sprayer - IN

20% Nanoemulsion and 100 µg recombinant protective antigen administered intranasally by Aptar Bidose Sprayer (400µL) Two doses administered 4 weeks apart

Biological - BW-1010: 100 µg - pipette - IN

20% Nanoemulsion and 100 µg recombinant protective antigen administered intranasally by pipette (400µL). Two doses administered 4 weeks apart.

Biological - Saline (Placebo) - sprayer - IN

Saline (negative control) administered intranasally by Aptar Bidose Sprayer (400µL). Two doses administered 4 weeks apart.

Biological - Saline (Placebo) - pipette - IN

Saline (negative control) administered intranasally by pipette (400µL). Two doses administered 4 weeks apart.

Biological - BioThrax (positive control) - SC

BioThrax licensed vaccine administered subcutaneously (500µL). Three doses administered 2 weeks apart.

Additional Information

Official Study Title

A 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

Clinical Trial ID

NCT04148118

ParticipAid ID

bmZJ0d