Multimeric-001 Universal Flu Vaccine: Phase IIa data

A double-blind, Israeli Phase IIa trial in 200 healthy volunteers showed that 2 doses of 500 µg adjuvanted Multimeric-001 Universal Flu Vaccine met the co-primary endpoint of significantly increasing IgG antibodies from baseline to day 42 vs. adjuvanted placebo (p<0.05). On the co-primary safety endpoint, the vaccine was well tolerated with no severe adverse events reported. Multimeric-001 also met the secondary endpoint of significantly increasing secretion of interferon (IFN) gamma vs. adjuvanted placebo (p<0.05).

Additionally, Multimeric-001 administered together with a 50% dose of the Vaxigrip seasonal trivalent inactivated influenza vaccine significantly increased the rates of hemagglutination inhibition (HAI) seroconversion vs. non-adjuvanted placebo plus the trivalent vaccine. Furthermore, the increase in HAI seroconversion rates were observed not only against strains that were included in Vaxigrip, but also against additional type A (H1N1 and H3N2) and type B influenza strains that were not included in the vaccine. Multimeric-001 was adjuvanted with Montanide ISA. Data will be presented at the BIO International Convention in Washington this month. ...