Intercell AG announced that the phase-II clinical trial with the company's vaccine candidate to prevent infections with the bacterium Pseudomonas aeruginosa is starting. Intercell's vaccine (IC43) 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, 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 this year.
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 our 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 ICU and hospital stay or number of antibiotic-free days.
"The initiation of this phase-II trial strengthens Intercell's leading position in the field of hospital acquired infections. Intercell's approach to develop vaccines and antibodies 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, chief operating officer of Intercell AG.
In addition to the in-house development of the Pseudomonas vaccine, Merck & Co Inc, together with Intercell develops a vaccine against S aureus infections, which is currently being tested in extensive phase-II clinical trials.
"After our recent excellent achievement obtaining both, the positive opinion in Europe and the recommendation for approval in Australia, we have been in a constant and very productive interaction with the FDA to finalize the license application as quickly as possible," said Intercell's chief executive officer, Gerd Zettlmeissl. "Although our year end target date for approval in the US will be missed we are very confident that we will be able to obtain approval in time to provide this important vaccine to US travellers and military personnel according to our original timelines."