Phase I Trial Finds Intranasal H5N1 Vaccine Safely Primes Broad Immune Response

Overview

• Researchers tested a recombinant H5 intranasal vaccine with BlueWillow’s NanoVax W805EC adjuvant in a randomized, controlled Phase I study of 40 healthy adults with placebo and non-adjuvanted controls.
• The regimen was safe and well tolerated, eliciting mucosal and systemic immunity including IgA and IgG antibodies, memory B and T cells, and antibody-dependent cellular cytotoxicity.
• Only those primed intranasally with the adjuvanted vaccine mounted strong responses after a single intramuscular H5 booster given six months later, indicating effective immune priming.
• Immune responses recognized multiple H5N1 clades, indicating early signs of breadth that require confirmation in larger efficacy studies.
• The peer-reviewed Nature Communications paper highlights shelf stability and possible dose sparing with the adjuvant and proposes ADCC and surface plasmon resonance assays as candidate biomarkers; funding came from NIAID (U01AI148081).