Pneumonia, Ventilator-Associated
Conditions
Brief summary
Randomized, placebo-controlled, partially blinded phase 2 pilot study. Multicenter study (approximately 50 centers) in approximately 9 countries. Proposed start date is December 2008. The study duration per patient is estimated to be 90 days. Overall study duration is estimated to be 12-18 months.
Detailed description
This is a randomized, placebo-controlled, multi-center, partially blinded \[i.e., 100 mcg and 200 mcg IC43 with Al(OH)3,, respectively\] and placebo, but unblinded for non-adjuvanted IC43 \[i.e., 100 mcg w/o Al(OH)3\] phase 2 pilot study. The study population consists of male or female ICU patients with a need for mechanical ventilation for more than 48 hours, aged between 18 and 80 years.
Interventions
BIOLOGICALIC43
DRUGPlacebo
NaCl
Sponsors
Valneva Austria GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Male or female patients aged between 18 and 80 years * Patients admitted to an ICU with a need for mechanical ventilation for more than 48 hours at visit 0 * At high risk for acquiring infection against P. aeruginosa at visit 0. * Patients who, as determined by the investigator, have a high probability of survival for at least 48 hours. * In females, either childbearing potential terminated by surgery or 1 year post menopausal, or a negative pregnancy test and the willingness of practicing a reliable methods of contraception * Written informed consent or waiver according to the national regulations
Exclusion criteria
* Known use of any other investigational or non-registered drug within 30 days prior to IC43 vaccination at Visit 0 * Low severity of illness defined by an acute physiology score \< 8 at visit 0 * Patients \< 6 months post organ transplantation * Severe thrombocytopenia or other coagulopathy which in the opinion of the investigator makes the patient unsuitable for intramuscular injection * Pregnancy, lactation * Persons who have been committed involuntarily to an institution, e.g. mental health facility or prison, will not participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Immunogenicity at day 14 as determined by OprF/I specific IgG antibody titer measured by ELISA in patients receiving IC43 or placebo | Day 14 |
Secondary
| Measure | Time frame |
|---|---|
| Immunogenicity at day 7 | Day 7 |
| Rate of serious adverse events | Day 7 |
| Safety laboratory parameters | Day 7 |
| Systemic tolerability | Day 7 |
| Local tolerability | Day 7 |
Countries
Austria
Outcome results
None listed