Intercell initiates Phase II Pseudomonas aeruginosa vaccine trial

In the Phase II clinical trial, 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, sepsis or soft tissue infection, will be vaccinated with Intercell’s prophylactic Pseudomonas aeruginosa vaccine. Two different dosages will be used in the trial. The dosages and vaccination schedule have been identified in a Phase I study initiated earlier in 2008.

For the current Phase II clinical trial, about 450 patients will be enrolled in more than 50 intensive care units in 11 countries in Europe and Latin America. The study aims to show induction of protective antibody responses against Pseudomonas aeruginosa. Antibodies are known to be the primary line of defense of human immune system against the intruding bacteria and are therefore the targeted immune response to be measured in the trial.

Additionally, the patients will be followed-up for infections caused by Pseudomonas aeruginosa, including pneumonia, sepsis, wound infections, urinary tract infections or tracheobronchitis. The overall benefit and quality of life will be assessed by parameters such as length of intensive care unit and hospital stay or number of antibiotic-free days.

In addition to the in-house development of the Pseudomonas vaccine, Merck & Co together with Intercell is developing a vaccine against Staphylococcus aureus infections, which is currently being tested in extensive Phase II clinical trials.

Intercell has also said that despite best collaborative efforts, it does not expect the FDA to complete all administrative steps of the application for Ixiaro, a vaccine for the prevention of Japanese encephalitis, by the company’s target date of December 31, 2008 and now is looking forward to a US approval in early 2009.