A randomized placebo-controlled phase II study of a Pseudomonas vaccine in ventilated ICU patients.

ABSTRACT:

Background

Currently, no vaccine against Pseudomonas is available. IC43 is a new, recombinant, protein (OprF/I)-based vaccine against the opportunistic pathogen, Pseudomonas aeruginosa, a major cause of serious hospital-acquired infections. IC43 has proven immunogenicity and tolerability in healthy volunteers, patients with burns, and patients with chronic lung diseases. In order to assess the immunogenicity and safety of IC43 in patients who are most at risk of acquiring Pseudomonas infections, it was evaluated in mechanically ventilated ICU patients.

Methods

We conducted a randomized, placebo-controlled, partially blinded study in mechanically ventilated ICU patients. The immunogenicity of IC43 at day 14 was determined as the primary endpoint, and safety, efficacy against

SUBMITTER: Rello J 

PROVIDER: S-EPMC5291979 | biostudies-literature | 2017 Feb

REPOSITORIES: biostudies-literature