Intercell AG has announced the start of a pivotal Phase II/III efficacy trial of its investigational Pseudomonas aeruginosa vaccine.
The trial follows an exploratory Phase II study in which lower all-cause mortality rates were observed in the vaccine groups as compared to the control group.
Pseudomonas aeruginosa is one of the leading causes of nosocomial infections, which are infections acquired or occurring during the course of hospitalization for other conditions.
Of the 2 million nosocomial infections in the U.S. alone per year, 10% are caused by Pseudomonas aeruginosa.
The bacterium is the number 1 cause of ventilator-associated pneumonia, the number 2 cause of hospital-acquired pneumonia and the number 4 cause of surgical site infections. Currently, there is no vaccine against Pseudomonas aeruginosa available.
The Phase II/III trial is a randomized, placebo-controlled double-blind study which will enroll a total of 800 ventilated intensive-care unit patients in approximately 40 study sites across five European countries.
Patients will be vaccinated twice with either the Pseudomonas aeruginosa vaccine candidate or placebo at a 7-day interval in addition to the standard of care.
The Pseudomonas aeruginosa vaccine candidate used will be the non-adjuvanted product formulation which was found to most impact the observed survival in the previous Phase II clinical study.
The primary objective of the trial is to compare all-cause mortality rates at day 28 after first vaccination between the two study groups.
Secondary objectives include comparison of infection-related mortality-rates and Pseudomonas aeruginosa infection rates between the groups and to investigate the vaccine candidate’s immunogenicity, safety and tolerability.
The study is sufficiently powered to show a clinically meaningful reduction in all-cause mortality with statistical significance between the vaccine and control group.
A futility analysis is planned after approximately 400 patients have been enrolled. The study has previously received positive scientific advice from the European Medicines Agency (EMA).
“We are very pleased that we can investigate our vaccine candidate to confirm the encouraging findings obtained in the previous Phase II trial. There are not many vaccine candidates in the final steps of development and this one could result in a major medical breakthrough”, said Thomas Lingelbach, CEO of Intercell AG.
First interim data are expected mid-2013. The Pseudomonas aeruginosa program is part of the Strategic Alliance between Novartis and Intercell - the trial will be conducted by Intercell and costs will be shared between both parties.