IC43: Additional Phase II data

A double-blind, European and Latin American Phase II trial in about 400 mechanically-ventilated intensive care patients showed that all IC43 vaccine groups met the primary endpoint of a significantly greater proportion of patients who achieved a seroconversion rate of 65-81% and IgG antibody geometric mean titers of 995-2,117 units/mL vs. placebo at day 14 post-first vaccination. Patients received placebo, 100 or 200 µg IC43 plus alum adjuvant, or 100 µg IC43 without adjuvant on days 0 and 7. Although the trial was not powered to detect statistical significance on the secondary endpoints, Intercell said all IC43 vaccine groups also met the secondary immunogenicity endpoints vs. placebo, including significant improvements in IgG response assessed 7 times over a 90-day period, functional antibody activity as measured by an opsonophagocytosis assay and antibody avidity. Intercell also said a lower mortality rate was observed in all vaccine groups vs. placebo, with a significantly lower rate in the non-adjuvanted IC43 group at day 28 vs. placebo (21.7 vs. 40%, p=0.0196). There were no significant differences in rates of P. aeruginosa infection or treatment emergent adverse events between treatment groups. ...