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

Summary

The purpose of this clinical trial is to evaluate the safety and immunogenicity of BW-1014. BW-1014 is a nanoemulsion (NE) adjuvanted recombinant Hemagglutinin 5 (rH5) that would protect against pandemic flu. The study will be conducted in 40 healthy adults volunteers, age 18 - 45, in one center in the United States. The study will compare 3 different dose levels of rH5 (25µg, 50µg and 100µg rH5 in 20% NE adjuvant using a pipette dropper with rH5 control (100µg without NE adjuvant) and placebo control (saline). The investigational product will be administered in 2 doses intranasally (IN). This will be followed 6 months later with a licensed H5N1 IIV IM vaccine. In addition to safety outcome, homologous and heterologous immunological outcomes will be tested in nasal wash, serum, and blood cells.

Timeline

Start

2022-07-07

Primary completion

2023-10-12

Completion

2023-10-12

Publications

• Deming ME, Toapanta FR, Pasetti M, Golding H, Khurana S, Hamouda T, Fattom A, Liang Y, Tennant SM, McGilvray MF, Bernal PJ, Oshinsky JJ, Datta S, Booth JP, Coughlan L, Neuzil KM, Costley CD, Kotloff KL, Sztein MB, Ortiz JR; rH5 Writing Group. An intranasal adjuvanted, recombinant influenza A/H5 vaccine primes against diverse H5N1 clades: a phase I trial. Nat Commun. 2025 Nov 6;16(1):9321. doi: 10.1038/s41467-025-64686-3.

Drugs

Indications