Overview
- In a randomized, controlled Phase I trial, 40 healthy adults received two intranasal doses of a recombinant H5 vaccine with or without BlueWillow’s NanoVax W805EC adjuvant, followed by an intramuscular H5 booster six months later.
- The intranasal regimen was safe and well tolerated, with adverse events largely limited to mild, transient nasal symptoms.
- Recipients mounted mucosal and systemic immune responses, and adjuvanted dosing produced higher IgA and IgG levels, more memory immune cells, and stronger antibody-dependent cellular cytotoxicity.
- Immune responses demonstrated activity against six H5N1 strains, including a currently circulating lineage associated with animal outbreaks and reported human cases in the United States.
- Investigators propose ADCC and surface plasmon resonance assays plus direct mucosal antibody measurements as biomarker readouts, and note the shelf-stable, potentially dose-sparing formulation now requires validation in larger trials.