Study Assessing Immunogenicity and Safety of IC43 In Intensive Care Patients - Full Text View

Sponsored by:	Intercell AG
Information provided by:	Intercell AG
ClinicalTrials.gov Identifier:	NCT00876252

Purpose

Randomized, placebo-controlled, double blinded phase 2 pilot study. Multicenter study (approximatelt 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.

Condition	Intervention	Phase
Ventilated Associated Pneunomia	Biological: IC43 Pseudomonas Aeruginosa Drug: phosphate buffered saline (PBS)	Phase II

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety Study
Official Title:	A Phase 2 Pilot Study Assessing Immunogenicity and Safety of IC43 in Itensive Care Patients

Further study details as provided by Intercell AG:

Primary Outcome Measures:

Immunogenicity at day 14 as determined by OprF/I specific IgG antibody titer measured by ELISA in patients receiving IC43 or placebo [ Time Frame: Day 14 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Immunogenicity at day 7 [ Time Frame: Day 7 ] [ Designated as safety issue: Yes ]
Rate of serious adverse events [ Time Frame: Day 7 ] [ Designated as safety issue: Yes ]
Safety laboratory parameters [ Time Frame: Day 7 ] [ Designated as safety issue: Yes ]
Systemic tolerability [ Time Frame: Day 7 ] [ Designated as safety issue: Yes ]
Local tolerability [ Time Frame: Day 7 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	450
Study Start Date:	December 2008
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator IC43 100 mcg	Biological: IC43 Pseudomonas Aeruginosa
2: Active Comparator IC43 200 mcg	Biological: IC43 Pseudomonas Aeruginosa
3: Placebo Comparator phosphate buffered saline solution containing 0,9 % NaCl and 400 mcg aluminum hydroxide as an adjuvant	Drug: phosphate buffered saline (PBS) NaCl

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00876252

Show 35 Study Locations

Sponsors and Collaborators

Intercell AG

Investigators

Study Director:	Nicole Haas	Intercell AG
Study Director:	Sonja Ernsthofer	Intercell AG

More Information

No publications provided

Responsible Party:	Intercell AG ( Intercell AG )
Study ID Numbers:	IC43-201
Study First Received:	April 3, 2009
Last Updated:	April 3, 2009
ClinicalTrials.gov Identifier:	NCT00876252 History of Changes
Health Authority:	Germany: Bundesamt für Sicherheit im Gesundheitswesen

ClinicalTrials.gov processed this record on May 07, 2009