VIENNA, Oct. 25 /PRNewswire-FirstCall/ -- Intercell AG (VSE: ICLL) today announced results from a Phase II clinical trial involving the company's investigational nosocomial vaccine candidate (IC43) against infections with the bacterium Pseudomonas aeruginosa, a leading cause of hospital-acquired infections with increasing antibiotic resistance and hence a very high unmet medical need.
In the randomized, controlled Phase II clinical trial (33 sites in 8 countries), about 400 mechanically ventilated intensive care patients, who are at particular high risk of acquiring severe and often life-threatening forms of Pseudomonas aeruginosa infections, such as Ventilator-Associated Pneumonia (VAP), sepsis or soft tissue infection were vaccinated on days zero and seven in four treatment groups receiving 100 or 200mcg alum-adjuvanted vaccine, 100mcg non-adjuvanted vaccine or alum as placebo control.
The primary endpoint of the study was met in that all vaccine groups showed good seroconversion rates (65 - 81%) with IgG antibody Geometric Mean Titers (GMTs) (995-2117 ELISA units/ml). There were no significant differences in treatment emergent adverse events between the treatment arms and local and systemic tolerability appeared to be good, as far as assessable in this study population. The number and nature of reported drug related adverse events does not raise any safety concern and has been confirmed earlier by a Data Safety Monitoring Board (DSMB) based on interim data.
Secondary immunogenicity endpoints were also met in this study and included IgG response assessed seven times over a period of 90 days, measurement of functional antibody activity by opsonophagocytosis assay, and measurement of antibody avidity.
Overall robust immunogenicity following second vaccination was observed in all vaccine groups. A dose-response could be observed, whereas alum did not show a clear immune-enhancing effect. Antibody avid