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Study Assessing Immunogenicity and Safety of IC43 In Intensive Care Patients

This study has been completed.
Information provided by (Responsible Party):
Valneva Austria GmbH Identifier:
First received: April 3, 2009
Last updated: October 18, 2012
Last verified: October 2012
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.

Condition Intervention Phase
Pneumonia, Ventilator-Associated
Biological: IC43
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2 Pilot Study Assessing Immunogenicity and Safety of IC43 in Intensive Care Patients

Further study details as provided by Valneva Austria GmbH:

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 ]

Secondary Outcome Measures:
  • Immunogenicity at day 7 [ Time Frame: Day 7 ]
  • Rate of serious adverse events [ Time Frame: Day 7 ]
  • Safety laboratory parameters [ Time Frame: Day 7 ]
  • Systemic tolerability [ Time Frame: Day 7 ]
  • Local tolerability [ Time Frame: Day 7 ]

Enrollment: 400
Study Start Date: December 2008
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: IC43 100 mcg
IC43 100 mcg with Aluminum hydroxide
Biological: IC43
Other Name: IC43 Pseudomonas Aeruginosa
Active Comparator: IC43 200 mcg
IC43 200 mcg with Aluminum hydroxide
Biological: IC43
Other Name: IC43 Pseudomonas Aeruginosa
Active Comparator: IC43 100 mcg w/o
IC43 100 mcg without Aluminum hydroxide
Biological: IC43
Other Name: IC43 Pseudomonas Aeruginosa
Placebo Comparator: Placebo
phosphate-buffered saline solution containing 0,9 % NaCl and 400 mcg Aluminum hydroxide as an adjuvant
Drug: Placebo
Other Name: phosphate buffered saline (PBS)

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.

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00876252

Medical University of Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Valneva Austria GmbH
Study Director: Nicole Haas Valneva Austria GmbH
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Valneva Austria GmbH Identifier: NCT00876252     History of Changes
Other Study ID Numbers: IC43-201
Study First Received: April 3, 2009
Last Updated: October 18, 2012

Additional relevant MeSH terms:
Pneumonia, Ventilator-Associated
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Cross Infection
Ventilator-Induced Lung Injury
Lung Injury
Aluminum Hydroxide
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents processed this record on May 25, 2017