40
Participants
Start Date
July 7, 2022
Primary Completion Date
October 12, 2023
Study Completion Date
October 12, 2023
BW-1014: 25 µg rH5 in 20% NE - pipette - IN
20% Nanoemulsion and 25 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 50 µg rH5 in 20% NE - pipette - IN
20% Nanoemulsion and 50 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
BW-1014: 100 µg rH5 in 20% NE - pipette - IN
20% Nanoemulsion and 100 µg recombinant H5 antigen administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
rH5 (100 µg) control - pipette - IN
100 µg recombinant H5 antigen (without adjuvant) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
Saline (Placebo) - pipette - IN
Saline (negative control) administered intranasally by an electronic pipette (500µL) Two doses administered 4 weeks apart
H5N1 IIV - IM
90 µg H5N1 IIV administered intramuscularly (1 mL) One booster dose administered 6 months following last immunization
Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore
Lead Sponsor
University of Maryland, Baltimore
OTHER
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
BlueWillow Biologics
INDUSTRY