Intercell and Novartis have agreed to advance Intercell’s investigational Pseudomonas aeruginosa vaccine into a confirmatory clinical efficacy trial in ventilated intensive care unit patients.
The double-blind study is designed to demonstrate a clinically meaningful and statistically significant reduction in overall mortality between the vaccine and control group.
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The study will compare two groups, who will receive standard of care in addition to the vaccine or a placebo.
The primary endpoint of the study will be mortality at day 28 after first vaccination in both study groups.
Secondary objectives are to assess Pseudomonas aeruginosa infections, infection-related mortality, immune response to the vaccine candidate, and its safety and tolerability.
The study will be conducted in various countries, predominantly in the EU, and will enrol approximately 800 subjects across 50 study sites.
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By GlobalDataIntercell will execute the trial, while the costs will be shared with Novartis.
Intercell CEO Gerd Zettlmeissl said that Pseudomonas infections are a major cause of mortality in artificially ventilated intensive care unit patients.
“Our Phase II data showed a statistically significant improved survival of patients vaccinated and we are happy that we will, together with Novartis, move the programme forward,” Zettlmeissl said.
