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Vaccines for preventing infection with Pseudomonas aeruginosa in cystic fibrosisJohansen HK, Gøtzsche PC
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SummaryVaccines for preventing infection with Pseudomonas aeruginosa in cystic fibrosisCystic fibrosis is a hereditary disease where thick mucus is produced in the lungs. Pseudomonas aeruginosa and other bacteria cause long-lasting lung infections which result in permanent lung damage. Vaccines aimed at reducing infection with Pseudomonas aeruginosa have been developed, and it is important to know whether vaccination can prevent lung infection. We searched for randomised controlled trials and included three trials with 483, 476 and 37 patients respectively. No data are available from one of the large trials, which is unpublished. In the other large trial and in the small trial, the risk of getting a chronic infection was not decreased. In the large trial, one patient was reported to have died in the observation period. In that trial, 227 adverse events (four severe) were registered in the vaccine group and 91 (one severe) in the control group. We cannot recommend the use of vaccines against Pseudomonas aeruginosa.
This is a Cochrane review abstract and plain language summary, prepared and maintained by The Cochrane Collaboration, currently published in The Cochrane Database of Systematic Reviews 2010 Issue 1, Copyright © 2010 The Cochrane Collaboration. Published by John Wiley and Sons, Ltd.. The full text of the review is available in The Cochrane Library (ISSN 1464-780X).
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January 25. 1999 AbstractBackgroundChronic pulmonary infection in cystic fibrosis results in progressive lung damage. Once colonisation of the lungs with Pseudomonas aeruginosa occurs, it is almost impossible to eradicate. Vaccines, aimed at reducing infection with Pseudomonas aeruginosa, have been developed. ObjectivesTo assess the effectiveness of vaccination against Pseudomonas aeruginosa in cystic fibrosis. Search strategyWe searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Trials Register using the terms vaccines AND pseudomonas (last search 07 May 2009) and PubMed using the terms vaccin* AND cystic fibrosis (last search 11 May 2008). Selection criteriaRandomised trials (published or unpublished) comparing Pseudomonas aeruginosa vaccines (oral, parenteral or intranasal) with control vaccines or no intervention in cystic fibrosis. Data collection and analysisThe authors independently selected trials, assessed them and extracted data. Main resultsSix 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. There was a marked rise in flagella antibody titres in the vaccine group and no change in the placebo group (P < 0.0001). Authors' conclusionsVaccines against Pseudomonas aeruginosa cannot be recommended. |