Demographics, immunogenicity and safety data of the study group
| Demographics | Nutritional status | ||
| Patients enrolled: 48 | |||
| Mean age: 14.4 years (range 8 months–26 years) | |||
| M/F: 20/28 | Patients<18 years (n=32): | mean HAP 25.1 | |
| F508del (37/48, 77.1%): | 8 homozygotes | mean WAP 41.8 | |
| 29 heterozygotes | |||
| Pseudomonas colonisation: 29/48 (60.4%) | Patients≥18 yrs (n=16): | mean BMI 21.9 | |
| Mean FEV1: 86.5%±25.1 | |||
| O2 therapy: 1 patient | |||
| Immunogenicity* | |||
| Patients assessed: 33 | Baseline | 21 days postimmunisation | |
| CD4 T cell/μl (%) | 1163 (42.3) | – | |
| Geometric mean titre (95% CI) | 40 (20–81) | 582 (388–872) | |
| Geometric mean ratio of HI titre (95% CI) | – | 13.9 (6.9–26.7) | |
| % Seroconversion (95% CI) | – | 83 (60–91) | |
| Safety | |||
| Local reactions: | 13/48 (27.1%) | Pain | 12/48 (25%) |
| Swelling/redness | 7/48 (14.6%) | ||
| Systemic reactions: | 12/48 (25%) | Fever | 5/48 (10.4%) |
| Myalgia | 4/48 (8.3%) | ||
| Headache | 3/48 (6.3%) | ||
| Fatigue | 3/48 (6.3%) | ||
| Chills | 1/48 (2.1%) | ||
↵* Immunogenicity was assessed according to the CPMP criteria: seroconversion was defined as prevaccination antibody titre of 1:10 or less and a postvaccination titer of 1:40 or more or a prevaccination titre greater than 1:10 and an increase in the antibody titre by a factor of four or more. Seroconversion rate was calculated as the percentage of patients that displayed seroconversion. Serum antibody titres were determined using the haemagglutination inhibition (HI) assay. Sera geometric mean titres (GMT) and ratios (as fold increase) in HI titres of day 21 to day 0 titres were also calculated.
HAP, height for age percentile; WAP, weight for age percentile; BMI, body mass index; FEV1, forced expiratory volume in 1 s.