A double-blind randomized placebo-controlled phase III study of a Pseudomonas aeruginosa flagella vaccine in cystic fibrosis patients.

ABSTRACT: Pseudomonas aeruginosa causes life-threatening lung infections in patients with cystic fibrosis. We hypothesized that vaccination may prevent P. aeruginosa lung infection. In a double-blind, placebo-controlled, multicenter trial, 483 European patients, 2-18 years of age without P. aeruginosa colonization were randomly assigned to receive four intramuscular injections of a bivalent P. aeruginosa flagella vaccine or placebo over a 14-month period. Patients were evaluated quarterly for P. aeruginosa-positive throat cultures and antipseudomonal serum antibody titers during the study period of 2 years. The vaccine was well tolerated, and the patients developed high and long-lasting serum antiflagella IgG titers. In the intention-to-treat group (all patients enrolled), 82 of 239 vaccinated patie

SUBMITTER: Doring G 

PROVIDER: S-EPMC1904125 | biostudies-literature | 2007 Jun

REPOSITORIES: biostudies-literature