A double-blind, randomised, placebo-controlled phase III study of the efficacy of a bivalent Pseudomonas aeruginosa flagella vaccine in patients with cystic fibrosis

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN98785888

Enrollment

483

Registered

2006-12-12

Start date

1997-05-06

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic fibrosis Nutritional, Metabolic, Endocrine Cystic fibrosis

Interventions

For each patient a package of four pre-filled 1 ml syringes, numbered with the randomisation code, and containing either 40 µg flagella protein (20 µg flagella of subtype a0a1a2 from P. aeruginosa str

Eligibility

Inclusion criteria

Inclusion criteria: 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%

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
Secondary criteria for efficacy were: 1. A difference between the vaccine and the placebo groups in specific serum antibody titres against the inoculated antigens; 2. The distribution of P. aeruginosa flagella subtype strains between the vaccine and the placebo groups.	—

Countries

Austria, France, Germany, Italy

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026