Intercell provides update on ongoing Phase II vaccine studies
- Category: Vaccines
- Published on Wednesday, 16 December 2009 02:00
- Hits: 1106
* Pseudomonas vaccine: Study in intensive care patients to investigate immunogenicity and safety of a Pseudomonas aeruginosa vaccine and to assess Pseudomonas infection rates - Interim results from the study confirms good safety and immunogenicity of the vaccine
* Pandemic Influenza: Intercell originally anticipated it would have data available at the end of the year, but due to data processing not yet completed, data will only be available at the beginning of next year
Vienna, Austria | December 16, 2009 | Intercell AG (VSE; "ICLL") today announced that interim data from a Phase II clinical trial investigating the company's vaccine candidate for the prevention of infections with the bacterium Pseudomonas aeruginosa are available. Intercell's vaccine is a recombinant subunit vaccine consisting of two outer membrane proteins of Pseudomonas aeruginosa.
In the Phase II clinical trial, mechanically ventilated intensive care patients are vaccinated with Intercell's prophylactic Pseudomonas aeruginosa vaccine. These patients are at a particularly high risk of acquiring severe and often life-threatening forms of Pseudomonas aeruginosa infections, such as ventilator-associated Pneumonia, Sepsis or soft tissue infection. Two different dosages of alum-adjuvanted vaccine and one formulation without adjuvant are used in the placebo-controlled trial.
The interim analysis from 225 out of 400 total patients to be vaccinated in this study has shown good safety and tolerability of the vaccine. In addition, robust immunogenicity by antibody induction which were assessed by standard and avidity IgG ELISA and functional opsonization assays could be shown. Functional antibodies are expected to be the major protective mechanism against Pseudomonas aeruginosa infections. Immune responses and safety data observed in intensive care patients appear largely comparable to results from a preceding Phase I trial in healthy volunteers. Based on these interim data an independent Safety Board recommended the continuation of the study. Meanwhile, the trial is fully enrolled, having achieved recruitment of 400 patients in more than 40 intensive care units in nine countries in Europe and Latin America.
"We are pleased with the state of the clinical conduct although the interim data are not yet decisive. Intercell's approach to develop vaccines against the major causes of nosocomial infections has the clear potential to become the unique strategic solution for a dramatically increasing medical need," comments Thomas Lingelbach, COO of Intercell AG.
As another objective, the current Phase II trial investigates the feasibility of performing pivotal efficacy studies in this target population. The interim analysis confirms the anticipated number of Pseudomonas aeruginosa infections; in total 73/225 patients tested positive for Pseudomonas aeruginosa at any point in time, 23/225 fulfilled the secondary endpoint definitions of invasive disease (Bacteremia, Pneumonia). This observed rate of ~10% is well within expectations, as only study sites with estimated infection rates of 10-25% were selected for this trial. These results confirm the development strategy for Intercell's Pseudomonas aeruginosa vaccine and suggest feasibility of the pivotal assessment of vaccine efficacy in future Phase III trials.
However, no conclusions concerning pilot efficacy can yet be drawn at this stage with regards to a meaningful reduction of infections in the different study groups. This assessment will only be concluded at the point of the final data analysis of all 400 patients in the study.
SOURCE: Intercell AG