Intercell receives positive scientific advice from EMA for Pseudomonas vaccine Phase II/III-study

13-Oct-2011 - Austria

Intercell AG announced that it has received positive Scientific Advice from the European Medicines Agency (EMA) regarding the planned Phase II/III efficacy trial of its investigational Pseudomonas aeruginosa vaccine. The company obtained confirmation for the proposed key elements of the study design, i.e. size, population, and primary endpoint.

The trial follows a Phase II study in which a lower mortality rate was observed in the vaccine groups as compared to the control group. Based on the positive feedback Intercell intends to initiate the confirmatory efficacy study in Q1/2012. First interim data are expected mid 2013. The program is part of the Strategic Alliance between Novartis and Intercell – the trial will be executed by Intercell and cost will be shared between both parties.

The planned double blind study is powered to show a clinically meaningful reduction in overall mortality with statistical significance between the vaccine and control group and target enrollement is about 800 patients. The trial is expected to be conducted in various countries in the EU, involving up to 50 study sites. Two study groups, both receiving standard of care in addition to vaccine or placebo, will be compared. Subjects in the vaccine group which will comprise about 400 ventilated ICU patients will be vaccinated twice within a 7-day interval with the non-adjuvanted product formulation that was found to most impact observed survival in the previous Phase II clinical study. Primary endpoint of the trial will be mortality at day 28 after first vaccination in both study groups. Secondary objectives are to investigate Pseudomonas aeruginosa infections, infection-related mortality as well as immune responses to the vaccine candidate and its safety and tolerability.

https://www.bionity.com/en/news/134799/intercell-receives-positive-scientific-advice-from-ema-for-pseudomonas-vaccine-phase-ii-iii-study.html