Nanoemulsion-adjuvanted influenza vaccine: Phase I data

In a single-blind, active- and placebo-controlled, dose-escalation Phase I trial in 199 healthy volunteers who had not previously received the Fluzone trivalent inactivated 2008-2009 vaccine, single doses of intranasal NB-1008 were well tolerated and exhibited adjuvant activity with doses of antigen that were 30% lower than commercial intramuscular vaccines. Specifically, NB-1008 administered as a 10% oil-in-water emulsion combined with 30 µg Fluzone elicited "clinically meaningful" systemic immunity as measured by >2.5-fold increases in geometric mean titer and >40% seroconversion for all 3 influenza strains in the vaccine. ...