Safety and immunogenicity of a BPL-inactivated, whole-virus, universal influenza vaccine: a randomized, double-blinded, double-dummy, placebo-controlled, phase 1 clinical trial
Year: 2026
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
Abstract: Influenza inflicts substantial burden of disease, but current vaccines have limited breadth of protection against strains and subtypes not in the vaccine. BPL-1357, a whole-virus, inactivated vaccine containing four wild-type, low-pathogenicity avian influenza viruses has demonstrated remarkable protection in animal models against a wide range of influenza viruses. In this phase I trial, forty-five healthy participants were randomized to receive BPL-1357 intramuscularly (IM), intranasally (IN), or placebo, in a prime and boost strategy, 28-days apart. The primary endpoints consisted of adverse events (AEs) and serious adverse events (SAEs) from enrollment through 28 days after the boost. The secondary endpoints were AEs and SAEs through 182 days after the boost and measurement of serum IgG and nasal IgA titers against hemagglutinin and neuraminidase vaccine antigens. Adverse effects were mostly mild and, other than mild injection-site pain more frequently observed in the IM group, occurred in a minority of patients. IM BPL-1357 induced higher serum IgG titers against H3, H5, and H7 relative to placebo, with 71.4%, 71.4%, and 85.7% of participants demonstrating a response. IM BPL-1357 vaccinated participants also experienced serum neutralizing and NA-specific responses, but no mucosal IgA responses against HA or NA. Subtle mucosal and serum responses were observed after IN vaccination, similar to preclinical experiments. These results suggest that BPL-1357 is well tolerated and immunogenic, particularly when given IM, but more work is needed to assess other dose levels, further characterize induced immunity, and evaluate efficacy against influenza infection and disease (NCT05027932).
Source: Nature Communications
Authors: Luca T. Giurgea, Alison Han, Lindsay M. Czajkowski, Holly Ann Baus, Gregory Mak, Matthias Lingemann, Ian Bellayr, Adriana Cervantes-Medina, Monica Gouzoulis, Kimberly Adao, Jenna Sherry, Rani Athota, Jackqueline Ardo, Robert Daniels, Viviane Callier, Jaekeun Park, Sally Hunsberger, Mattia Bonsignori, John H. Powers, John C. Kash, Jeffery K. Taubenberger, Matthew J. Memoli
Institutions: National Institutes of Health, National Institute of Allergy and Infectious Diseases, Center for Biologics Evaluation and Research, United States Food and Drug Administration, Frederick National Laboratory for Cancer Research, Virginia–Maryland College of Veterinary Medicine, University of Maryland, College Park, University of Trento, Office of the Director
Language: English
Subfield: Epidemiology
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $6,990
OpenAlex ID: W7225722942