Study Assessing Immunogenicity and Safety of IC43 In Intensive Care Patients

Study Overview
=================
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.

Official Title
-----------------
A Phase 2 Pilot Study Assessing Immunogenicity and Safety of IC43 in Intensive Care Patients

Conditions
-----------------
Pneumonia, Ventilator-Associated

Intervention / Treatment
-----------------
* Biological: IC43
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: IC43 100 mcg<br>IC43 100 mcg with Aluminum hydroxide | Biological: IC43<br> <br> * Other names: IC43 Pseudomonas Aeruginosa;|
| Active Comparator: IC43 200 mcg<br>IC43 200 mcg with Aluminum hydroxide | Biological: IC43<br> <br> * Other names: IC43 Pseudomonas Aeruginosa;|
| Active Comparator: IC43 100 mcg w/o<br>IC43 100 mcg without Aluminum hydroxide | Biological: IC43<br> <br> * Other names: IC43 Pseudomonas Aeruginosa;|
| Placebo Comparator: Placebo<br>phosphate-buffered saline solution containing 0,9 % NaCl and 400 mcg Aluminum hydroxide as an adjuvant | Drug: Placebo<br>* NaCl<br>* Other names: phosphate buffered saline (PBS);|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 |