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Intercell Reports Positive Results From Its Phase II Pseudomonas Aeruginosa Investigational Vaccine Study for Certain Hospital-Acquired Infections
Date:10/25/2010

ity was similar in all vaccine groups. Functional opsonozation-uptake could be shown and correlated well with vaccine-induced IgG titers. Induction of functional antibodies is expected to be the major protective mechanism against Pseudomonas aeruginosa infections. Immune responses in intensive care patients appeared weaker compared to results from a preceding Phase I trial in healthy volunteers. This was not unexpected due to the reduced general health condition of patients enrolled.

Although this trial was not powered for efficacy the Clinical Endpoint Committee (CEC) confirmed infection rates and mortality were recorded within the secondary endpoints analysis.

A lower mortality rate was observed in all vaccine groups as compared to the control group.  The reduction in mortality rate was statistically significant (p = 0.0196) for the non-adjuvanted vaccine (21.7% day 28 mortality in the not-adjuvanted IC43 group compared to 40.0% day 28 mortality in the placebo group).

No significant difference in Pseudomonas aeruginosa infection rates between any of the groups was apparent. However, this is likely to be due to the relatively small sample size of the current Phase II study. Larger, sufficiently powered clinical studies would be required to validate and verify any vaccine effects on mortality and infection rates.

As another key objective, the current Phase II trial investigated the feasibility of performing pivotal efficacy studies in this difficult target population: Final data confirm the anticipated number of Pseudomonas aeruginosa infections. The observed attack rate of 6 - 14% is well within expectations as only study sites with estimated Pseudomonas aeruginosa invasive infection rates of 10 - 25% were selected for this trial. These results confirm the development strategy for Intercells's Pseudomonas aeruginosa vaccine and could allow a pivotal assessment o
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SOURCE Intercell AG
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