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
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