Study design (if review, criteria of inclusion for studies)
Randomised trials (published or unpublished) comparing Pseudomonas aeruginosa vaccines (oral, parenteral or intranasal) with control vaccines or no intervention in cystic fibrosis.
List of included studies (3)
Döring 2007; Lang 2004b; Langford 1983
Participants
Patients with CF, diagnosed on the basis of abnormal sweat test or genotype, or both, of all ages and degrees of disease severity, regardless of the P. aeruginosa colonisation status.
Interventions
Vaccines for preventing infection with Pseudomonas aeruginosa
Outcome measures
Primary outcomes 1. Time to chronic P. aeruginosa infection 2. Pulmonary function (FEV1, FVC) 3. Mortality
Main results
Six trials were identified. Two trials were excluded since they were not randomised and one old, small trial because it was not possible to assess whether is was randomised. The three included trials comprised 483, 476 and 37 patients, respectively. No data have been published from one of the large trials, but the company stated in a press release that the trial failed to confirm the results from an earlier study and that further clinical development was suspended. In the other large trial, relative risk for chronic infection was 0.91 (95% confidence interval 0.55 to 1.49), and in the small trial, the risk was also close to one. In the large trial, one patient was reported to have died in the observation period. In that trial, 227 adverse events (4 severe) were registered in the vaccine group and 91 (1 severe) in the control group. In this large trial of a vaccine developed against flagella antigens, antibody titres against the epitopes contained in the vaccine were higher in the vaccine group compared to the placebo group (P < 0.0001).
Authors' conclusions
Vaccines against Pseudomonas aeruginosa cannot be recommended.