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

PHASE1CompletedINTERVENTIONAL
Enrollment

84

Participants

Timeline

Start Date

January 8, 2020

Primary Completion Date

September 2, 2021

Study Completion Date

September 2, 2021

Conditions
Anthrax
Interventions
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."

Trial Locations (1)

66219

Johnson County Clin-Trial, Lenexa

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Porton Biopharma Ltd.

UNKNOWN

lead

BlueWillow Biologics

INDUSTRY