Intercell Starts Phase 2 Trial for P. aeruginosa Vaccine

Intercell AG (Vienna, Austria) has begun the Phase 2 clinical trial of the company's vaccine candidate to prevent infections with the bacterium Pseudomonas aeruginosa. The vaccine (IC43) is a recombinant subunit vaccine consisting of two outer membrane proteins of P. aeruginosa.

In the Phase 2 clinical trial, mechanically ventilated intensive care patients, who are at particular high risk of acquiring severe and often life-threatening forms of P. aeruginosa infections such as ventilator-associated pneumonia, sepsis, or soft tissue infection, will be vaccinated with the prophylactic P. aeruginosa vaccine. Two different dosages will be used in the trial. The dosages and vaccination schedule have been identified in a Phase 1 study initiated earlier this year.

For the current Phase 2 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 P. aeruginosa. The patients also will be assessed for infections caused by P. 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 ICU and hospital stay or number of antibiotic-free days.Intercell also announced that it has transferred its preclinical Group B Streptococcus (GBS) vaccine program to Novartis (Basel, Switzerland). At the same time,

Intercell has kept and received co-exclusive rights for the development of therapeutic antibodies against GBS and has in-licensed additional rights on GBS antibodies from Novartis.