A double-blind, randomised, placebo-controlled phase III study of the efficacy of a bivalent Pseudomonas aeruginosa flagella vaccine in patients with cystic fibrosis
- Conditions
- Cystic fibrosisNutritional, Metabolic, Endocrine
- Registration Number
- ISRCTN98785888
- Lead Sponsor
- The Society for the fight of Cystic Fibrosis (The Gesellschaft zur Bekämpfung der Mukoviszidose e.V.) (Germany)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 483
1. Cystic fibrosis that has been diagnosed according to conventional criteria
2. Patients aged between two and 18 years
3. No infection with P. aeruginosa as assessed by a negative throat swab culture and negative serum antibody titres against the P. aeruginosa antigens exotoxin A
4. Alkaline protease and elastase in enzyme-linked immunosorbent assays (ELISAs)
5. A forced expiratory volume in one second (FEV1) of at least 70% of the predicted value
6. A weight-to-height ratio of at least 90%
7. An oxygen saturation of at least 92%
1. A known allergy to thiomersal or mercury
2. A prolonged bleeding time or a pathological partial thromboplastin time (PTT) value
3. Were using immunosuppressive drugs such as systemic corticosteroids
4. Participating in other clinical studies
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The lower frequency or complete absence of P. aeruginosa pulmonary infection in the vaccine group compared to the placebo group during the two-year observation period of the study. Infection was defined by having one or more P. aeruginosa positive throat swabs or positive serum antibody titres against the P. aeruginosa antigens alkaline proteinase, elastase and exotoxin A (primary endpoint one). The primary endpoint two was defined as three positive throat swabs and/or three positive serum antibody titres against the P. aeruginosa antigens alkaline proteinase, elastase and exotoxin A within a 12 month period during the study, to assess chronic P. aeruginosa infection in the patient groups.
- Secondary Outcome Measures
Name Time Method Secondary criteria for efficacy were: <br>1. A difference between the vaccine and the placebo groups in specific serum antibody titres against the inoculated antigens; <br>2. The distribution of P. aeruginosa flagella subtype strains between the vaccine and the placebo groups.