Vaccines for preventing infection with <I>Pseudomonas aeruginosa</I> in cystic fibrosis

Johansen HK, Gøtzsche PC

Published Online:

July 6, 2011

Cystic 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 No data are available from one of the large trials, which is unpublished.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.

Abstract (click to read)

Background:

Chronic 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.

Objectives:

To assess the effectiveness of vaccination against Pseudomonas aeruginosa in cystic fibrosis.

Search strategy:

We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Trials Register using the terms vaccines AND pseudomonas (last search 19 April 2011) and PubMed using the terms vaccin* AND cystic fibrosis (last search 25 May 2011).

Selection criteria:

Randomised trials (published or unpublished) comparing Pseudomonas aeruginosa vaccines (oral, parenteral or intranasal) with control vaccines or no intervention in cystic fibrosis.

Data collection and analysis:

The authors independently selected trials, assessed them and extracted data.

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. There was a marked rise in flagella antibody titres in the vaccine group and no change in the placebo group (P < 0.0001).

Authors' conclusions:

Vaccines against Pseudomonas aeruginosa cannot be recommended.

This record should be cited as:

Johansen HK, Gøtzsche PC. Vaccines for preventing infection with Pseudomonas aeruginosa in cystic fibrosis. Cochrane Database of Systematic Reviews 2008, Issue 4. Art. No.: CD001399. DOI: 10.1002/14651858.CD001399.pub2

Assessed as up to date:

May 25, 2011

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Primary Review Group:

Cystic Fibrosis and Genetic Disorders Group

Health topics:

Genetic disorders > Cystic fibrosis > Influenza

Genetic disorders > Cystic fibrosis > Vaccine

Lungs & airways > Cystic fibrosis > Influenza

Lungs & airways > Cystic fibrosis > Vaccine

Cochrane Summaries^beta

Independent high-quality evidence for health care decision making

Vaccines for preventing infection with <I>Pseudomonas aeruginosa</I> in cystic fibrosis

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