A Cochrane review that has found no evidence that Pseudomonas aeruginosa vaccine is effective in patients with cystic fibrosis has called for unpublished data to be released.
The Cystic Fibrosis and Genetic Disorders Group said results from two trials showed that after vaccination the risk of getting a chronic infection did not decrease and lung function was not improved.
However they noted that data from one of the trials published in 2004 by Lang et al. had not been made public.
A press release distributed in 2006 announced that the company had suspended further clinical development but did not contain any data, said review authors Helle Johansen and Peter Gøtzche.
They contacted the company and were initially informed that they could obtain the unpublished data but have not received any information, they explained.
“We believe it is an obligation towards the patients who volunteered for the trial that the results of their efforts and altruism become publicly available,” they wrote.
“Other researchers may develop vaccines and it is important to know about past successes and failures to proceed as rationally as possible,” they added.