A multicenter vaccine trial using the Pseudomonas aeruginosa flagella vaccine IMMUNO in patients with cystic fibrosis.

Pseudomonas aeruginosa is a major pathogen in patients with cystic fibrosis (CF). In CF patients the opportunistic pathogen causes chronic pulmonary infections which are difficult to treat with antibiotics. Loss of lung function is the major cause of death in CF. Vaccination against P. aeruginosa is a possible way to prevent these infections and flagella antigens of P. aeruginosa seem to be promising vaccine candidates. In vitro and animal studies showed that flagella antigens were protective both as actively administered immunogens and in passive studies in compromised animals. Phase I studies using IMMUNO's flagella vaccines in healthy individuals revealed that, intramuscularly administered, these vaccine preparations were well tolerated, showed no adverse side effects and gave rise to high and longlasting antibody titers in the circulation of the individuals. Furthermore, immunisation with a flagella vaccine elicited specific anti-flagella antibodies not only systemically, but also in the secretory immune system of the airways. Consequently, a phase III multicenter vaccine trial using the Pseudomonas aeruginosa 5142/1210-Flagella Vaccine IMMUNO was initiated. The study design is placebo-controlled, randomized and double-blind, involving 400 CF patients without P. aeruginosa lung infection m 16 CF centers in Germany, France and Italy. The study will start in the fall of 1996 and will be carried out for 2 years.

RCT Entities:   Population Interventions Outcomes