FluINsure™, an inactivated trivalent influenza vaccine for intranasal administration, is protective in human challenge with A/Panama/2007/99 (H3N2) virus

Abstract

FluINsure™ is an intranasal influenza vaccine containing inactivated antigens with the Proteosome™ adjuvant. Preclinical and human data have shown a good safety profile and immune responses in both the systemic compartment and mucosal compartments. We immunized adults with baseline A/Panama/2007/99 serum hemagglutination inhibition (HAI) titers<20 with placebo or with one or two doses of FluINsure. Forty-two days after the first dose, subjects were challenged intranasally with A/Panama. Subjects were observed for 7 days. Clinical illness occurred in 47.6% of placebo recipients. Two-dose recipients demonstrated 71.4% protection against any illness and 100% protection against systemic illness. When only illnesses associated with evidence of A/Panama infection were considered, efficacy of the two-dose regimen was 100% and the one-dose regimen 47.5%. A confirmatory second study was recently completed.